Dissolution Methods

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Drug Name	Dosage Form	USP Apparatus	Speed (RPMs)	Medium	Volume (mL)	Recommended Sampling Times (minutes)	Date Updated
Abacavir Sulfate	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Abacavir Sulfate/Dolutegravir Sodium/Lamivudine	Tablet	II (Paddle)	85	0.01 M Phosphate Buffer with 0.5% sodium dodecyl sulfate (SDS), pH 6.8	900	Abacavir and lamivudine: 10, 15, 20, 30 and 45; Dolutegravir: 5,15, 25, 35 and 45.	05/28/2015
Abacavir Sulfate/Dolutegravir Sodium/Lamivudine	Tablet (For Suspension)	II (Paddle)	50	0.01 M Phosphate Buffer with 0.5 mM EDTA, pH 6.8	500	5, 10, 15, 30, 45 and 60	10/06/2023
Abacavir Sulfate/Lamivudine	Tablet	II (Paddle)	75	0.1 N HCl	900	10, 20, 30, and 45	01/03/2007
Abacavir Sulfate/Lamivudine/Zidovudine	Tablet	II (Paddle)	75	0.1 N HCl	Acid Stage: 900 mL; Buffer Stage: 1000 mL	5, 10, 15, 30 and 45	01/03/2007
Abemaciclib	Tablet	II (Paddle)	75	0.01 N HCl	900	5, 10, 15, 20 and 30	11/16/2017
Abiraterone Acetate	Tablet	II (Paddle)	50	0.25% SLS in 56.5 mM phosphate buffer, pH 4.5	900	10, 20, 30, 45 and 60	02/28/2013
Abrocitinib	Tablet	II (Paddle) with peak vessels	55	Citrate-phosphate buffer, pH 3.5	900	10, 20, 30 and 45	05/18/2023
Acalabrutinib	Capsule	II (Paddle)	50	0.1 N HCl	900	10, 15, 20 and 30	08/17/2023
Acamprosate Calcium	Tablet (Delayed Release)	I (Basket)	180	Acid Stage: 0.1 N HCl Buffer Stage: "Citrate-sodium hydroxide" buffer pH 6.8 (150 ml of 2N NaOH, 21.014 gm of citric acid and ultra-pure water to 1000 ml) (Method B)	Media 1: 750 mL pH 1.1±0.1; Media 2: 950 mL pH 6.0±0.1; Media 3: 1000 mL pH 7.5±0.1	120 (Acid) 30, 60, 90, 120, and 180 (buffer)	12/20/2005
Acarbose	Tablet			Develop a dissolution method			09/15/2023
Acarbose	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Acetaminophen	Suppository	II (Paddle)	50	Phosphate buffer, pH 5	900	15, 30, 45, 60 and 90	08/17/2006
Acetaminophen	Tablet (Extended Release)			Refer to USP			03/03/2011
Acetaminophen/Aspirin/Caffeine	Tablet			Develop a dissolution method			01/03/2024
Acetaminophen/Butalbital	Tablet			Develop a dissolution method			09/15/2023
Acetaminophen/Butalbital/Caffeine	Tablet			Develop a dissolution method			01/03/2024
Acetaminophen/Butalbital/Caffeine/Codeine Phosphate	Capsule			Develop a dissolution method			09/15/2023
Acetaminophen/Caffeine/Dihydrocodeine Bitartrate	Capsule			Develop a dissolution method			09/15/2023
Acetaminophen/Caffeine/Dihydrocodeine Bitartrate	Tablet			Develop a dissolution method			09/15/2023
Acetaminophen/Hydrocodone Bitartrate	Tablet			Refer to USP (provide individual unit data).			08/15/2013
Acetaminophen/Ibuprofen	Tablet	II (Paddle)	50	50 mM Phosphate Buffer, pH 7.2	900	5, 10, 15, 20, and 30	02/09/2023
Acetaminophen/Oxycodone	Tablet			Refer to USP			01/14/2008
Acetaminophen/Oxycodone HCl	Tablet (Extended Release)	II (Paddle) with sinker	100	0.1 N HCl	900	0.25, 0.5, 1, 2, 4, 6 and 8 hours	11/19/2015
Acetaminophen/Pentazocine HCl	Tablet			Develop a dissolution method			09/15/2023
Acetaminophen/Tramadol HCl	Tablet	II (Paddle)	50	0.1 N HCl	900	5, 10, 15, 20 and 30	03/04/2006
Acetaminophen; Butalbital	Capsule			Develop a dissolution method			02/05/2024
Acetazolamide	Capsule (Extended Release)	II (Paddle)	75	Acetate Buffer, pH 4.5 with 2.2% Tween 20	900	1, 2, 5, 7, 9, 12 and 14 hours	01/15/2010
Acetazolomide	Tablet			Develop a dissolution method			01/03/2024
Acetylcysteine	Tablet (Effervescent)			Develop a dissolution method			07/28/2016
Acitretin	Capsule			Refer to USP			09/22/2011
Acrivastine/Pseudoephedrine HCl	Capsule	II (Paddle)	50	0.01 N HCl	900	5, 10, 15 and 30	01/12/2004
Acyclovir	Suspension	II (Paddle)	50	0.1 N HCl	900	10, 20, 30, 45 and 60	02/20/2004
Acyclovir	Tablet (Buccal)	I (Basket)	60	Phosphate Buffer, pH 6.0	1000	1, 2, 3, 5, 7, 9 and 12 hours	08/27/2015
Acyclovir	Capsule			Refer to USP			01/05/2012
Acyclovir	Tablet			Refer to USP			06/18/2007
Adagrasib	Tablet	II (Paddle)	75	pH 6.8 phosphate buffer with 0.3% SLS	900	10, 15, 30, 45 and 60	02/05/2024
Adefovir Dipivoxil	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Afamelanotide	Implant			Develop a method to characterize in vitro release			05/18/2023
Afatinib Dimaleate	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Albendazole	Tablet			Refer to USP			08/15/2013
Albendazole	Tablet (Chewable)	II (Paddle)	50	0.1 N HCl	900	10, 15, 20, 30 and 45	03/17/2016
Albuterol Sulfate	Tablet (Extended Release)	II (Paddle)	50	0.1 N HCl	900	1, 2, 4, 6, 9 and 12 hours	04/09/2007
Albuterol Sulfate	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Alectinib HCl	Capsule	II (Paddle) with sinker	100	pH 1.2, Simulated Gastric Fluid without pepsin, containing 4 % Triton X-100 [polyoxyethylene[10]octylphenyl ether]	900	10, 20, 30, 45, 60, 75 and 90	03/17/2016
Alendronate Sodium	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Alendronate Sodium/Cholecalciferol	Tablet			Develop a dissolution method			09/15/2023
Alfuzosin HCl	Tablet (Extended Release)	II (Paddle)	100	0.01 N HCl	900	1, 2, 12, 20 hours	06/18/2007
Aliskiren Hemifumarate	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Aliskiren Hemifumarate	Capsule (pellet)	I (Basket)	100	0.01 M HCl (degas)	500	5, 10, 15, 20, 30 and 45	02/08/2018
Aliskiren Hemifumarate/Amlodipine Besylate	Tablet	I (Basket)	100	0.01 N HCl, pH 2.0	500	10, 15, 20, 30 and 45	06/07/2012
Aliskiren Hemifumarate/Amlodipine Besylate/Hydrochlorothiazide	Tablet	I (Basket)	100	0.01 N HCl	900	10, 15, 20, 30 and 45	06/07/2012
Aliskiren Hemifumarate/Hydrochlorothiazide	Tablet	I (Basket)	100	0.1 N HCl	900	10, 15, 20, 30 and 45	10/08/2009
Aliskiren Hemifumarate/Valsartan	Tablet	I (Basket)	100	Phosphate Buffer, pH 6.8	1000	5, 10, 15, 20, 30 and 45	12/23/2010
Allopurinol	Tablet			Refer to USP			07/25/2007
Almotriptan Malate	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Alogliptin Benzoate	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Alogliptin Benzoate/ Metformin HCl	Tablet	II (Paddle)	50	0.01 N HCl	900	5, 10, 15, 20 and 30	11/19/2015
Alosetron HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Alprazolam	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Alprazolam	Tablet (Extended Release)	I (Basket)	100	1% Phosphate Buffer, pH 6.0	500	1, 4, 8, 12 and 16 hours	02/08/2007
Alprazolam	Tablet (Orally Disintegrating)	II (Paddle)	50	70 mM Potassium Phosphate Buffer, pH 6.0	500	2, 5, 10, 15 and 20	10/06/2008
Altretamine	Capsule			Refer to USP			01/29/2010
Aluminum Hydroxide/Magnesium Trisilicate	Tablet (Chewable)			Develop a dissolution method			05/12/2022
Alvimopan	Capsule	II (Paddle	50	0.1 N HCl	900	5, 10, 15, 20, 30 and 45	10/21/2010
Amantadine HCl	Capsule			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Amantadine HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Ambrisentan	Tablet	II (Paddle)	75	0.05 M Acetate Buffer, pH 5.0	900	5, 10, 15, 30, and 45	05/20/2009
Amifampridine	Tablet			Refer to FDA's Dissolution Guidance, 2018			08/19/2021
Amifampridine Phosphate	Tablet			Refer to FDA's Dissolution Guidance, 2018			08/19/2021
Amiloride HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Amiloride HCl/Hydrochlorothiazide	Tablet			Refer to USP			06/07/2012
Aminocaproic Acid	Tablet			Refer to FDA's Dissolution Guidance, 2018			01/03/2024
Aminosalicylic	Granule (Delayed Release)	II (Paddle)	100	Acid Stage: 0.1 N HCl; Buffer Stage 2: pH 7.5 Phosphate Buffer	1000	Acid Stage: 2 hours; Buffer Stage: 1, 2, 3 and 4 hours	07/14/2008
Amiodarone HCl (Test 1)	Tablet			Develop a dissolution method			09/15/2023
Amiodarone HCl (Test 2)	Tablet	I (Basket)	50	Acetate Buffer, pH 4.0, with 1% Tween 80	900	10, 20, 30, 45, 60 and 90	01/12/2004
Amitriptyline HCl	Tablet			Refer to USP			01/14/2008
Amlodipine Besylate	Tablet (Orally Disintegrating)	II (Paddle)	50	0.01 N HCl	500	5, 10, 15 and 20	10/06/2008
Amlodipine Besylate	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Amlodipine Besylate/Atorvastatin Calcium	Tablet	II (Paddle)	75	Phosphate Buffer, pH 6.8	900	5, 10, 15 and 30	04/02/2009
Amlodipine Besylate/Benazepril HCl	Capsule	I (Basket)	100	0.01 N HCl	500	10, 20 , 30, 45, and 60	06/20/2007
Amlodipine Besylate/Hydrochlorothiazide/Olmesartan Medoxomil	Tablet	II (Paddle)	50	Phosphate Buffer, pH 6.8	900	5, 10, 15, 20, 30 and 45	07/21/2011
Amlodipine Besylate/Hydrochlorothiazide/Valsartan	Tablet			Refer to USP			07/28/2016
Amlodipine Besylate/Olmesartan Medoxomil	Tablet	II (Paddle)	50	Phosphate Buffer, pH 6.8	900	10, 20, 30 and 45	08/11/2008
Amlodipine besylate/Perindopril Arginine	Tablet	II (Teflon coated paddle)	75	0.01 N HCL	1000	5, 10, 15, 20 and 30	03/17/2016
Amlodipine Besylate/Telmisartan	Tablet	II (Paddle)	75	Telmisartan: Phosphate Buffer, pH 7.5; Amlodipine: 0.01N HCl, pH 2	Telmisartan: 900; Amlodipine: 500	Telmisartan: 10, 15, 20, 30 and 45; Amlodipine: 10, 15, 20, 30 and 45	08/05/2010
Amlodipine Besylate/Valsartan	Tablet			Refer to USP			07/28/2016
Amoxicillin	Tablet (Extended Release)	II (Paddle)	100	3 Stage dissolution: 50 mM potassium phosphate monobasic buffer at pH 4.0 (0-2 hours), 6.0 (2-4 hours) and 6.8 ( 4 hours and beyond)	900	0.25, 0.5, 1, 2, 2.25, 2.5, 3, 4, 4.25, 4.5, 5 and 6 hours	10/21/2010
Amoxicillin	Capsule			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Amoxicillin	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Amoxicillin	For Oral Suspension			Develop a dissolution method			09/15/2023
Amoxicillin/Clarithromycin/Lansoprazole	Capsule/Tablet/Capsule (Copackage)			Develop a dissolution method for Amoxicillin Capsules, Refer to USP for monographs of Clarithromycin Tablets and Lansoprazole Delayed-Release Capsules			01/03/2024
Amoxicillin/Clarithromycin/Omeprazole	Capsule/Tablet/Capsule (Copackage)			Develop a dissolution method for Amoxicillin Capsules, Refer to USP for monographs of Clarithromycin Tablets and Omeprazole Delayed-Release Capsules			01/03/2024
Amoxicillin/Clavulanate Potassium	Tablet			Develop a dissolution method			01/03/2024
Amoxicillin/Clavulanate Potassium	Tablet (Chewable)			Develop a dissolution method			09/15/2023
Amoxicillin/Clavulanate Potassium	Suspension			Develop a dissolution method			09/15/2023
Amoxicillin/Omeprazole Mg./Rifabutin	Capsule (Delayed Release)	I (Basket	100	Amoxicillin/Rifabutin: 0.01 N HCl; Omeprazole: 0.1N HCl; Buffer Stage: 0.05M Phosphate buffer, pH 6.8	Amoxicillin/Rifabutin:900; Omeprazole: Acid Stage: 900; Buffer Stage:900;	Amoxicillin/Rifabutin: 5, 10, 15, 20 and 30; Omeprazole: Acid Stage: 120; Buffer Stage: 5, 10, 15, 20 and 30;	08/27/2020
Amoxicillin; Clarithromycin; Vonoprazan Fumarate	Capsule, Tablet, Tablet	Clarithromycin and Vonoprazan: II (Paddle)	Clarithromycin and Vonoprazan: 50	Amoxicillin: Develop a dissolution method; Clarithromycin: 0.1M Sodium Acetate Buffer (pH 5.0); Vonoprazan: 0.05M Acetate Buffer (pH 4.5)	900	10, 15, 30, 45, 60 and 90	02/05/2024
Amoxicillin; Vonoprazan Fumarate	Capsule, Tablet	Vonoprazan: II (Paddle)	Vonoprazan: 50	Amoxicillin: Develop a dissolution method; Vonoprazan: 0.05M Acetate Buffer (pH 4.5)	900	10, 15, 30, 45, 60 and 90	02/05/2024
Amphetamine	Tablet (Extended Release, Orally Disintegrating)	II (Paddle	75	Acid Stage: 0.1 N HCl; Buffer Stage: Phosphate Buffer, pH 6.8	Acid Stage: 900 mL; Buffer Stage: 1000 mL	Acid Stage: 10, 15, 30, 45, 60, 90, 120; Buffer Stage: 5, 10, 15, 30 and 45	07/28/2016
Amphetamine	Suspension (Extended Release)			Develop a dissolution method			12/22/2016
Amphetamine Aspartate/Amphetamine Sulfate/Dextroamphetamine Saccharate/Dextroamphetamine Sulfate	Tablet			Develop a dissolution method			09/15/2023
Amphetamine Aspartate/Amphetamine Sulfate/Dextroamphetamine Saccharate/Dextroamphetamine Sulfate	Capsule (Extended Release)	II (Paddle)	50	Dilute HCl, pH 1.1 for first 2 hrs, then add 200 mL of 200 mM Phosphate Buffer and adjust to pH 6.0 for the remainder	0-2 hrs: 750 mL. After 2 hrs: 950 mL	0.5, 1, 2, 3, and 4 hours	07/25/2007
Amphetamine Aspartate/Amphetamine Sulfate/Dextroamphetamine Saccharate/Dextroamphetamine Sulfate [12.5, 25, 37.5, 50 mg]	Capsule (Extended Release)	II (Paddle)	50	Media 1: pH 1.1±0.1, Dilute HCl 2 hours; Media 2: pH 6.0±0.1, Phosphate Buffer 3rd hour, Media 3: pH 7.5±0.1, Phosphate Buffer for the remainder	Media 1: 750 mL; Media 2: 950 mL; Media 3: 1000 mL	0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours	11/16/2017
Amphetamine ER	Capsule	II (Paddle)	50	750 ml of dilute HCl, pH 1.1 for the first 2 hours, then add 200 ml of 200 mM phosphate buffer, and adjust to pH 6 (w/ HCl or NaOH) for the remainder	750 ml of dilute HCl, 200 ml of phosphate buffer	1, 2, 3, 4, and 6 hours	08/17/2006
Amphetamine; Amphetamine Aspartate/Dextroamphetamine Sulfate	Tablet (Extended Release)	II (Paddle)	50	Stage 1: 500 mL of water for 1 hour; Stage 2: 700 mL of 0.001N HCl for next 2 hours (add 200 mL of HCl to Stage 1); Stage 3: 900 mL of Phosphate Buffer, pH 6.8 (add 200 mL of Potassium Phosphate Buffer to Stage 2)	Stage 1: 500; Stage 2: 700; Stage 3: 900	1, 3, 3.17, 3.25, 3.5, 3.75, 4, 6, 8 and 12 hours	05/12/2022
Amphotericin B	Injectable (Liposomal)			Develop a method to characterize in vitro release			07/28/2016
Ampicillin/Ampicillin Trihydrate	Capsule			Develop a dissolution method			09/15/2023
Ampicillin/Ampicillin Trihydrate	for Oral Suspension			Develop a dissolution method			09/15/2023
Amprenavir	Capsule	II (Paddle)	50	0.1 N HCl	900	10, 15, 30, and 45	02/19/2008
Anagrelide HCl	Capsule	I (Basket)	100	0.1 N HCl	900	5, 10, 15, 30 and 45	01/14/2004
Anastrozole	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Apalutamide	Tablet	II (Paddle)	75	0.25% sodium lauryl sulfate (SLS) in 0.05 M Sodium Phosphate Buffer, pH 4.5 (60 mg strength); 0.5% sodium lauryl sulfate (SLS) in 0.05 M Sodium Phosphate Buffer, pH 4.5 (240 mg strength)	900	5, 10, 15, 20, 30, and 45	02/16/2024
Apixaban	Tablet	II (Paddle)	75	0.05 M Sodium Phosphate Buffer with 0.05% SLS, pH 6.8	900	5, 10, 20, 30 and 45	05/09/2013
Apomorphine HCl	Film (Sublingual)	V (paddle over disk)	75	20mM BIS-TRIS HCl Buffer, pH 6.4	500	2.5, 5, 7.5, 10, 12.5, 15 and 20	08/19/2021
Apremilast	Tablet	II (Paddle)	60	0.15% SLS in 25 mM Sodium Phosphate Buffer, pH 6.8	900	10, 15, 20, 30, and 45	05/18/2017
Aprepitant	Capsule			Develop a dissolution method			09/15/2023
Aprepitant	Emulsion			Develop a method to characterize in vitro release			02/05/2024
Aprepitant	For Oral Suspension			Develop a dissolution method			09/15/2023
Aripiprazole	Tablet			Refer to USP			06/30/2016
Aripiprazole	For Intramuscular Suspension (Extended Release)	II (Paddle)	50	0.25% Sodium Dodecyl Sulfate (SDS) Solution	900	10, 15, 30, 60, 120, 180, 240, 300, 360, 420 and 480	06/25/2015
Aripiprazole	Tablet (Orally Disintegrating)	II (Paddle)	75	Acetate Buffer, pH 4.0	1000	10, 20, 30 and 45	08/11/2008
Armodafinil	Tablet	II (Paddle)	50	0.1 N HCl	900	10, 20, 30 and 45	01/14/2008
Asciminib HCl	Tablet	II (Paddle)	60	Citrate Buffer, pH 3.0	900	5, 10, 15, 20 and 45	10/06/2023
Asenapine	Transdermal	VI (Cylinder)	50	pH 5.1 Acetate Buffer at 32°C	900	1, 2, 3, 4, 6, 8, 10 and 12 hours	04/22/2021
Asenapine Maleate	Tablet (Sublingual)	II (Paddle)	50	Acetate Buffer, pH 4.5	500	1, 2, 3, 4 and 5	05/09/2013
Aspirin	Capsule			Refer to USP			05/28/2015
Aspirin	Capsule (Extended Release)	II (Paddle) with sinker	100	0.05M Potassium Phosphate Buffer (pH 7.4) with trypsin (.001%w/v) and sodium azide (.025% w/v)	900	1, 2, 3, 6, 9, 12, 16, 22 and 30 hours	10/20/2016
Aspirin/ Omeprazole	Tablet (Delayed Release)	I (Basket)	100	Acid Stage: 0.1 N HCl (degassed); Buffer Stage: Phosphate Buffer, pH 6.8 (degassed)	Acid Stage: 900; Buffer Stage: 900	Acid Stage:120; Buffer Stage:10, 20, 30, 45, 60 and 75	12/22/2016
Aspirin/Butalbital/Caffeine	Capsule			Develop a dissolution method			01/03/2024
Aspirin/Butalbital/Caffeine	Tablet			Develop a dissolution method			01/03/2024
Aspirin/Butalbital/Caffeine/Codeine Phosphate	Capsule			Develop a dissolution method			01/03/2024
Aspirin/Caffeine/Orphenadrine Citrate	Tablet			Develop a dissolution method			09/15/2023
Aspirin/Dipyridamole	Capsule	I (Basket)	100	0.01 N HCl for first hour, 0.1 M Phosphate Buffer, pH 5.5, thereafter	0-1 hrs: 900 mL. 900 mL thereafter	Acid: 10, 20, 30, 45 and 60 min; Buffer:1, 2, 5, and 7 hours	10/09/2007
Aspirin/Hydrocodone Bitartrate	Tablet	II (Paddle)	75	Acetate Buffer, pH 4.5	900	10, 20, 30, 45, 60 and 90	01/15/2004
Aspirin/Meprobamate	Tablet			Develop a dissolution method			09/15/2023
Aspirin/Methocarbamol	Tablet			Develop a dissolution method			09/15/2023
Aspirin/Oxycodone HCl	Tablet			Refer to USP			01/15/2010
Atazanavir Sulfate	Capsule	II (Paddle)	50	0.025 N HCl	1000	10, 20, 30 and 45	01/20/2006
Atazanavir Sulfate/ Cobicistat	Tablet	II (Paddle)	75	0.05 M Citrate Buffer (pH 2.8)	1000	Atazanavir: 10, 15, 20, 30 and 45; Cobicistat: 5, 10, 15, 20 and 30	12/24/2015
Atenolol	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Atenolol/Chlorthalidone	Tablet			Refer to USP			02/14/2014
Atogepant	Tablet			Refer to FDA's Dissolution Guidance, 2018			05/18/2023
Atomoxetine HCl	Capsule			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Atorvastatin Calcium	Suspension	II (Paddle)	75	0.05 M Phosphate Buffer, pH 6.8	900	5, 10, 15 and 30	05/31/2024
Atorvastatin Calcium	Tablet	II (Paddle)	75	0.05 M Phosphate buffer, pH 6.8	900	5, 10, 15 and 30	01/15/2004
Atorvastatin Calcium/Ezetimibe	Tablet	II (Paddle), with option to use a sinker for 20/10 mg strength	75	Phosphate buffer, pH 6.8 with 0.2% w/v Tween 80	900	5, 10, 15, 20, 30 and 45	05/15/2014
Atovaquone	Oral Suspension			Develop a dissolution method			07/21/2009
Atovaquone	Tablet	II (Paddle)	50	40% isopropanol buffered to pH 8.0 with potassium dihydrogen phosphate	900	10, 20, 30, 45, 60 and 90	06/18/2007
Atovaquone/Proguanil HCl	Tablet	II (Paddle) with PEAK vessels	50	40% isopropranol buffered to pH 8.0 with potassium dihydrogen phosphate	900	15, 30, 45 and 60	08/17/2006
Atropine Sulfate/ Diphenoxylate HCl	Tablet			Develop dissolution method(s) to characterize the dissolution of both components			12/22/2016
Auranofin	Capsule			Develop a dissolution method			09/15/2023
Avacopan	Capsule	II (Paddle) with sinker	50	0.1N HCl	900	10, 20, 30, 45 and 60	10/06/2023
Avanafil	Tablet	II (Paddle)	50	Simulated gastric fluid without pepsin.	900	5, 10, 15, 20 and 30	04/02/2015
Avapritinib	Tablet	II (Paddle)	75	0.05 M Sodium Acetate Buffer, pH 5.0 containing 0.5% w/v cetyl trimethylammonium bromide (CTAB)	900	5, 10, 15, 20, 30, 45, 60, 90 and 120	05/12/2022
Axitinib	Tablet	II (Paddle)	75	0.01 N HCl	900	5, 15, 30, 45 and 60	08/14/2014
Azacitidine	Tablet	II (Paddle)	75	50 mM phosphate buffer, pH 6.8	500	5, 10, 15, 20, 30 and 45	11/30/2023
Azacitidine	Injectable Suspension			Develop a dissolution method			09/03/2008
Azathioprine	Tablet			Develop a dissolution method			01/03/2024
Azilsartan Kamedoxomil	Tablet	II (Paddle)	50	Phosphate Buffer, pH 7.8 (deaerated)	900	5, 10, 15, 20, 30 and 45	05/09/2013
Azilsartan Kamedoxomil/Chlorthalidone	Tablet	II (Paddle)	50	Phosphate Buffer, pH 6.8 containing 1.0% Tween 80,	900	5, 10, 15, 20, 30 and 45	05/09/2013
Azithromycin	Oral Suspension	II (Paddle)	50	Phosphate buffer, pH 6.0	900	10, 20, 30, and 45	08/17/2006
Azithromycin	Tablet			Refer to USP			12/22/2016
Azithromycin	Capsule			Refer to USP			12/22/2016
Azithromycin	Suspension (Extended Release)	II (Paddle)	50	Phosphate Buffer, pH 6.0	900	15, 30, 45, 60, 120 and 180	04/15/2008
Baclofen	Tablet (Orally Disintegrating)	II (Paddle)	25	50 mM Acetate Buffer, pH 4.5	500 mL (10 mg) or 1000 mL (20mg)	5, 10, 15 and 30	07/14/2008
Baclofen	Tablet			Refer to USP			12/15/2009
Baclofen	Suspension	II (Paddle)	25	0.01 N HCl	500	5, 10, 15, 30, 45 and 60	05/31/2024
Baclofen	Granules	II (Paddle)	50	0.01 N HCl	500	5, 10, 15 and 30	02/05/2024
Baloxavir Marboxil	For Suspension	II (Paddle)	25	Phosphate Buffer, pH 6.8 containing 0.16% w/v cetyl trimethylammonium bromide (CTAB)	900	5, 10, 15, 20 and 30	02/09/2023
Baloxavir Marboxil	Tablet	II (paddle)	50	20 mg: Phosphate Buffer, pH 6.8 with 0.07% w/v (CTAB); 40 mg: Phosphate Buffer, pH 6.8 with 0.16% w/v CTAB; 80 mg: Phosphate Buffer, pH 6.8 with 0.40 w/v cetyltrimethylammonium bromide (CTAB)	900	5, 10, 15, 20, 30 and 45	07/07/2023
Balsalazide Disodium	Capsule	II (Paddle) with sinker	50	pH 6.8 buffer	900	10, 20, 30, and 45	01/26/2006
Balsalazide Disodium	Tablet			Develop a dissolution method			09/15/2023
Baricitinib	Tablet	II (Paddle)	75	Acetate buffer pH 4.5	900	5, 15, 30, 45	03/30/2023
Bedaquiline Fumarate	Tablet	I (Basket)	150	0.01 N HCl	900	10, 15, 20, 30 and 45	06/06/2013
Belzutifan	Tablet	II (Paddle)	50	50 mM potassium phosphate buffer at pH 6.5 with 68 mM potassium chloride (@37°C)	900	10, 15, 20, 30, 45 and 60	07/07/2023
Bempedoic Acid	Tablet	II (Paddle)	50	0.05 M Phosphate buffer, pH 6.6	900	5, 10, 15, 20 and 30	08/19/2021
Bempedoic Acid/Ezetimibe	Tablet	II (Paddle)	50	Bempedoic Acid: 0.05 M Phosphate buffer, pH 6.6; Ezetimibe: 0.05M Sodium Acetate Buffer pH 4.5 with 0.45% SLS	900	5, 10, 15, 20, 30, and 45	08/19/2021
Benazepril HCl	Tablet			Develop a dissolution method			09/15/2023
Benazepril HCl/Hydrochlorothiazide	Tablet	I (Basket)	100	0.1 N HCl	500	10, 20, 30 and 45	01/16/2004
Bendroflumethiazide/Nadolol	Tablet			Refer to USP			07/25/2007
Benzonatate	Capsule			Develop a dissolution method			01/03/2024
Benzoyl Peroxide; Clindamycin Phosphate	Gel			Develop a method to characterize in vitro release			05/18/2023
Benzphetamine HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Bepridil HCl	Tablet	I (Basket)	100	0.1 N HCl	900	10, 20, 30, 45 and 60	01/16/2004
Berotralstat HCl	Capsule			Refer to FDA's Dissolution Guidance, 2018			02/09/2023
Betamethasone Acetate/Betamethasone Sodium Phosphate	Injectable Suspension	IV (Flow through cell)	Flow @ 8 mL/min	0.05% SLS, pH 3.0 or Develop an in vitro release method using USP IV (Flow-Through Cell), and, if applicable, Apparatus II (Paddle) or any other appropriate method, for comparative evaluation by the Agency		5, 10, 15, 30, 45, 60, 90, 120, 180, 240, 300, and 360	04/08/2010
Bethanechol Chloride	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Bethanechol Chloride	Tablet			Refer to USP			10/06/2008
Betrixaban	Capsule			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Bexagliflozin	Tablet	I (Basket)	50	0.1 N HCl	900	1, 3, 5, 8 and 10 hours	05/31/2024
Bexarotene	Capsule	II (Paddle)	50	Tier 1 Medium: 0.5% HDTMA in 0.05 M phosphate buffer, pH 7.5 Tier 2 Medium: 0.5% HDTMA in 0.05 M phosphate buffer, pH 7.5 with 0.05 g/L pancreatin enzyme	900	15, 30, 45 and 60	08/17/2006
Bicalutamide	Tablet			Develop a dissolution method			09/15/2023
Bimatoprost	Implant			Develop a method to characterize in vitro release			07/07/2023
Bisacodyl/Polyethylene glycol 3350/ Potassium Chloride/Sodium Bicarbonate/ Sodium Chloride	Tablet (Delayed Release), For Solution,	II (Paddle)	100	Acid stage: 0.1 N HCl: Buffer stage: 0.05 M Phosphate buffer, pH 6.8, with 0.15% sodium lauryl sulfate (SLS) [only for Bisacodyl Tablets]	Acid stage: 900 mL; Buffer stage: 900 mL	Acid stage: 60; Buffer stage: 10, 20, 30, 45 and 60	03/02/2017
Bismuth Subcitrate Potassium/Metronidazole/Tetracycline HCl	Capsule			Develop a dissolution method			09/15/2023
Bismuth Subsalicylate (BiSub)/Metronidazole (Met)/Tetracycline HCl (Tet)	BiSub: Tablet (Chewable) /Met:Tablet /Tet: Capsule	II (Paddle)	50	BiSub: 0.1 N HCl /Met: Refer to USP /Tet: Refer to FDA's Dissolution Guidance, 2018	900	5, 10, 15, 20 and 30	07/07/2022
Bisoprolol Fumarate	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Bisoprolol Fumarate/Hydrochlorothiazide	Tablet	II (Paddle)	75	0.1 N HCl	900	5, 10, 20, 30 and 45	01/20/2004
Boceprevir	Capsule	II (Paddle) with sinker	50	50 mM phosphate buffer, pH 6.8 with 0.1% sodium dodecyl sulfate	900	10, 20, 30, 45, 60 and 75	01/31/2013
Bosentan	Tablet (For Suspension)	II (Paddle)	75	0.1 N HCl with 0.5% sodium dodecyl sulfate (SDS), pH 1.1	900	5, 10, 15, 20 and 30	11/16/2017
Bosentan	Tablet			Develop a dissolution method			09/15/2023
Bosutinib Monohydrate	Tablet	II (Paddle)	50	0.1 N HCl	900	10, 15, 20, 30 and 45	06/25/2015
Brexpiprazole	Tablet	II (Paddle)	50	0.05 M Acetate buffer, pH 4.3	900	10, 15, 20, 30 and 45	10/20/2016
Brigatinib	Tablet	II (Paddle)	70	50 mM Potassium Phosphate Buffer, pH 7.2	900	5, 10, 15, 20, 30 and 45	11/02/2017
Brimonidine Tartrate/Brinzolamide	Ophthalmic Suspension			Develop a method to characterize in vitro release			01/15/2015
Brincidofovir	Tablet	I (Basket)	50	50 mM sodium phosphate buffer, pH 6.4 + 0.3% SDS	900	5, 10, 15, 20, 30, 45, 60, 75 and 90	07/07/2023
Brincidofovir	Suspension	II (Paddle)	50	0.05 M Sodium Phosphate Monobasic, Monohydrate Buffer, pH 6.4 + 0.05% Tween 80	900	5, 10, 15, 20, 30, 45, 60, 75 and 90	07/07/2023
Brinzolamide	Ophthalmic Suspension			Develop a method to characterize in vitro release			09/01/2011
Brivaracetam	Tablet	II (Paddle	50	Phosphate Buffer, pH 6.4	2.5 and 5 mg tablets: 500 mL; 10, 25, 50, 75 and 100 mg tablets: 900 mL	5, 10, 15, 20 and 30	07/28/2016
Bromocriptine Mesylate	Tablet			Refer to USP			07/25/2007
Budesonide	Capsule	II (Paddle) with sinker	75	Acid stage: 0.1 N HCl; Buffer stage: Phosphate Buffer, pH 7.5	Acid stage: 1000; Buffer stage: 1000	Acid stage: 2 hours; Buffer stage: 0.25, 0.5, 1, 2, 4, 6 and 8 hours	02/25/2015
Budesonide	Tablet (Extended Release)	II (Paddle)	100	Acid Stage: 0.1 M HCl containing 0.5% Macrogol Cetostearyl Ether; Buffer Stage: pH 7.2 phosphate buffer containing 0.5% Macrogol Cetostearyl Ether.	Acid Stage: 500 mL ; Buffer Stage: 1000 mL	Acid Stage: 2 hours; Buffer Stage: 1, 2, 4, 6, 8 and 10 hours	04/02/2015
Bumetanide	Tablet			Develop a dissolution method			01/03/2024
Bupivacaine	Solution (Extended Release), Infiltration	II (Paddle)	50	0.025 M Sodium Phosphate Buffer with 0.03% Sodium Dodecyl Sulfate (SDS), pH 7.4	900	1, 2, 4, 8, 12, 16, 24, 36 and 48 hours	07/07/2022
Buprenorphine	Film, Transdermal (Extended Release)	VI (Cylinder) with adapter, if needed	50	0.9% Sodium Chloride at 32°C	600	0.5,1, 2, 4, 6, 8,12, 16 and 24 hours	05/09/2013
Buprenorphine HCl	Film (Buccal)	I (Basket)  100 mL round bottom vessel	100	0.05M NaH2PO4.H2O Phosphate Buffer, pH 4.5	60	10, 15, 20, 30, 45 and 60	10/20/2016
Buprenorphine HCl	Implant	II (Paddle)	50	Water	900	1, 4, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours	07/28/2016
Buprenorphine HCl	Tablet (Sublingual)			Develop a dissolution method			09/15/2023
Buprenorphine HCl/Naloxone HCl	Tablet (Sublingual)			Develop a dissolution method			09/15/2023
Buprenorphine HCl/Naloxone HCl	Film (Sublingual)	V (Paddle over Disk) with 56 mm, 40 mesh stainless steel disk.	100	Acetate Buffer, pH 4.0 (12.5mM Sodium acetate trihydrate and 60mM glacial acetic acid. Adjust the pH with glacial acetic acid or ammonium hydroxide).	900	1, 2, 3, 5, 7 and 10	10/31/2013
Bupropion HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Bupropion HCl	Tablet (Extended Release)			Develop a dissolution method			01/03/2024
Bupropion Hydrobromide	Tablet (Extended Release)	I (Basket)	75	0.1 N HCl	900	1, 2, 4, 6, 8 and 10 hours	06/10/2009
Buspirone Hydrochloride	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Busulfan	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Busulfan	Tablet			Develop a dissolution method			09/15/2023
Cabergoline	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Cabotegravir	Suspension (Extended Release)	II (Paddle)	20	0.5% w/v cetyltrimethylammonium bromide (CTAB) in 140 mM McIlvaine buffer, pH 7.4	1000	5, 10, 20, 30, 45 and 60	07/07/2023
Cabotegravir (CABO); Rilpivirine (RILP)	Suspension, Extended release	II (Paddle)	20 (CABO); 50 (RILP)	0.5% w/v solution of cetyltrimethylammonium bromide (CTAB) in 140 mM McIlvaine buffer, pH 7.4 (CABO); 6.0% w/v Polysorbate 20 in 0.05 M Sodium Phosphate buffer, pH 7.4 (RILP)		5, 10, 15, 20, 30, 45 and 60 (CABO); 5, 30, 90 and 360 (RILP)	05/18/2023
Cabotegravir Sodium	Tablet	II (Paddle)	60	0.01N HCl with 0.2% cetyltrimethylammonium bromide (CTAB)	1000	5, 10, 15, 20, 25 and 30	07/07/2022
Cabozantinib S-Malate	Tablet	II (Paddle	75	0.01 N HCl with 0.375% Triton X-100 (degassed)	900	5, 10, 15, 20 and 30	07/28/2016
Cabozantinib S-Malate	Capsule	II (Paddle) with sinker	75	0.01 N HCl with 0.5% Triton X-100 (degassed)	900	5, 10, 15, 20 and 30	06/02/2016
Caffeine; Ergotamine Tartrate	Suppository	II (Paddle)	50	1% Tartaric Acid	900	10, 15, 30, 35, 40 and 45	02/05/2024
Calcifediol	Capsule (Extended Release)	II (Paddle) with sinker	75	0.5% SDS in 5 mM Sodium Dihydrogenphosphate Monohydrate, pH 6.8	500	1, 2, 4, 6, 8, 10 and 12 hours	10/20/2016
Calcitriol	Capsule			Develop a quantitative rupture test			06/03/2008
Calcium Acetate	Capsule			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Calcium Acetate	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Calcium carbonate/Famotidine/ Magnesium hydroxide	Tablet, Chewable	III (Reciprocating Cylinder)		0.1 M Sodium Acetate, pH 4.5	900	5,10, 15, 20, 30 and 45	03/30/2023
Canagliflozin	Tablet			Develop a dissolution method			09/15/2023
Canagliflozin (Can)/ Metformin HCl (Met)	Tablet (Extended Release)	Met: I (Basket, 40 mesh): Can: I (Basket, 10 mesh [with option of tablet holder])	Met: 100: Can:100	Met: Simulated Gastric Fluid [SGF] without enzyme, pH 1.2; Can: 0.1% (w/v) polysorbate 20 in 0.05 M sodium phosphate buffer pH 6.8 ( 50 mg); 0.2% (w/v) polysorbate 20 in 0.05 M sodium phosphate buffer pH 6.8 (150 mg)	Met: 900: Can: 900	Met: 1, 2, 4, 6, 8 10 and 12 hours: Can: 10, 15, 20, 30, 45 and 60 minutes;	12/22/2016
Canagliflozin/Metformin HCl	Tablet	II (Paddle)	Canagliflozin: 75; Metformin: 50	Canagliflozin (50 mg): 0.025 % Polysorbate 20; Canagliflozin (150 mg):0.075 % Polysorbate 20; Metformin: Phosphate buffer, pH 6.8	Canagliflozin (50 mg): 900; Canagliflozin (150 mg): 900 ; Metformin: 1000	Canagliflozin: 10, 15, 20, 30 and 45; Metformin: 5, 10, 15, 20 and 30	05/28/2015
Candesartan Cilexetil (16 mg, 8 mg and 4 mg)	Tablet	II (Paddle)	50	0.35% Polysorbate 20 in 0.05 M Phosphate Buffer, pH 6.5	900	10, 20, 30, 45 and 60	06/20/2007
Candesartan Cilexetil (32 mg)	Tablet	II (Paddle)	50	0.70% Polysorbate 20 in 0.05 M Phosphate Buffer, pH 6.5	900	10, 20, 30, 45 and 60	06/20/2007
Candesartan Cilexetil/Hydrochlorothiazide (16/12.5 mg)	Tablet	II (Paddle)	50	0.35% Polysorbate 20 in phosphate buffer pH 6.5	900	10, 20, 30, 45 and 60	01/29/2010
Candesartan Cilexetil/Hydrochlorothiazide (32/12.5 mg and 32/25 mg)	Tablet	II (Paddle)	50	0.70% Polysorbate 20 in phosphate buffer pH 6.5	900	15, 20, 30, 45 and 60	01/29/2010
Capecitabine	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Capmatinib HCl	Tablet	I (Basket)	75	0.01N HCl (degassed)	900	5, 10, 15, 20, 30 and 45	05/12/2022
Captopril	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Carbamazepine	Capsule (Extended Release)	II (Paddle)	75	First 4 hours: Dilute Acid, pH 1.1. After 4 hours: Phosphate Buffer, pH 7.5 with 0.1% sodium lauryl sulfate (SLS).	First 4 h: 900. After 4 h: 900	1, 2, 4, 6, 8, 10 and 12 hours	09/01/2011
Carbamazepine	Tablet			Develop a dissolution method			01/03/2024
Carbamazepine	Tablet (Chewable)			Develop a dissolution method			09/15/2023
Carbamazepine	Suspension			Develop a dissolution method			09/15/2023
Carbamazepine	Tablet (Extended Release)			Develop a dissolution method			01/03/2024
Carbidopa	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Carbidopa/Entacapone/Levodopa	Tablet	I (Basket)	Carbidopa and Levodopa: 50; Entacapone: 125	For both Carbidopa and Levodopa: 0.1 N HCl, For Entacapone: Phosphate buffer pH 5.5	Carbidopa and Levodopa: 750 ml. Entacapone: 900 ml	10, 20, 30, 45 and 60	01/03/2007
Carbidopa/Levodopa	Tablet (Orally Disintegrating)	II (Paddle)	50	0.1 N HCl	750	5, 10, 15, 30, and 45	07/25/2007
Carbidopa/Levodopa	Capsule (Extended Release)	I (Basket)	75	Acid stage: Simulated Gastric Fluid [SGF] without enzyme; Buffer stage: pH 7.0, 50 mM Phosphate Buffer	Acid stage: 500 mL [for 23.75/95 mg strength], 900 mL [other strengths]; Buffer stage:500 mL [for 23.75/95 mg strength], 900 mL [other strengths]	Acid stage: 30, 60 and 120; Buffer stage: 15, 30, 60, 90, 120, 180 and 240	04/07/2016
Carbidopa/Levodopa	Tablet			Refer to FDA's Dissolution Guidance, 2018			04/22/2021
Carbidopa/Levodopa	Suspension (Enteral)	II (Paddle)	25	0.05 M Sodium Acetate Buffer, pH 4.5	500	5, 10, 15, 20, 30, 40 and 60	10/20/2016
Carbidopa/Levodopa	Tablet (Extended Release)	II (Paddle)	50	0.1 N HCl	900	0.5, 0.75, 1, 1.5, 2, 2.5, 3 and 4 hours	08/15/2013
Carbinoxamine Maleate	Tablet			Develop a dissolution method			01/03/2024
Carbinoxamine Maleate	Suspension (Extended Release)	II (Paddle)	50	0.4 M Phosphate Buffer	900 [ 895 mL 0.4 M Buffer +5 mL Suspension]	0.5, 1, 2, 3, 4, 6, 8 and 12 hours	06/02/2016
Carglumic Acid	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Cariprazine HCl	Capsule	I (Basket)	100	Sodium Acetate Buffer, pH 5.0 (degas)	500	5, 10, 15, 20, 30 and 45	06/30/2016
Carisoprodol	Tablet			Refer to USP			01/29/2010
Carvedilol	Tablet			Refer to USP			12/24/2015
Carvedilol	Tablet	II (Paddle)	50	SGF without enzyme	900	10, 20, 30 and 45	01/21/2004
Carvedilol Phosphate	Capsule (Extended Release)	II (Paddle)	100	0.1 N HCl	900	1, 2, 4, 6, 8, 12, 18 and 24 hours	10/31/2013
Cedazuridine/Decitabine	Tablet	II (Paddle)	75	50 mM phosphate buffer, pH 6.8	900	5, 10, 15 and 30	07/07/2022
Cefaclor	Capsule			Develop a dissolution method			01/03/2024
Cefaclor	Tablet (Chewable)			Develop a dissolution method			01/03/2024
Cefaclor	Tablet (Extended Release)			Refer to USP			03/03/2011
Cefadroxil	Tablet			Develop a dissolution method			01/03/2024
Cefadroxil	Capsule			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Cefadroxil	Suspension			Develop a dissolution method			09/15/2023
Cefdinir	Capsule	II (Paddle)	50	Phosphate Buffer, pH 6.8	900	5, 10, 15, 30 and 45	07/25/2007
Cefdinir	Suspension	II (Paddle)	50	0.05 M Phosphate buffer, pH 6.8	900	10, 20, 30 and 45	04/09/2007
Cefditoren Pivoxil	Tablet	II (Paddle)	75	Simulated Gastric Fluid without enzyme	900	5, 10, 15, 20 and 30	01/15/2010
Cefixime	Tablet (Chewable)	II (Paddle	25	Phosphate Buffer, pH 7.2	900	10, 15, 20, 30, and 45	12/23/2010
Cefixime	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Cefixime	Suspension	II (Paddle)	50	0.05 M Phosphate buffer, pH 7.2	900	10, 20, 30 and 45	04/09/2007
Cefixime	Capsule	I (Basket)	100	0.05 M Phosphate Buffer, pH 7.2	900	10, 20, 30, 45 and 60	08/15/2013
Cefpodoxime Proxetil	Suspension	II (Paddle)	50	Glycine Buffer (0.04 M) pH 3.0	900	10, 20, 30 and 45	12/20/2005
Cefpodoxime Proxetil	Tablet			Refer to USP			07/25/2007
Cefprozil	Tablet			Develop a dissolution method			01/03/2024
Cefprozil	For Oral Suspension			Develop a dissolution method			09/15/2023
Cefprozil Monohydrate	Suspension			Develop a dissolution method			09/15/2023
Ceftibuten Dihydrate	Suspension	II (Paddle)	50	0.05 M Phosphate Buffer, pH 7.0	1000	10, 20, 30 and 45	01/21/2004
Cefuroxime Axetil	Tablet			Refer to USP			07/25/2007
Celecoxib	Capsule	II (Paddle)	50 mg, 100 mg and 200 mg: 50 rpm; 400 mg: 75 rpm	Tier 1 Medium: 0.04 M tribasic sodium phosphate (pH 12) with 1% SLS. Tier 2 Initial Medium: 750 mL of simulated gastric fluid, USP (includes pepsin); At 20 minutes, while stirring, add 180 mL of appropriate concentrations of SLS solution (for a final concentration of 1% SLS). Add about 70 mL of 1.2 N NaOH to adjust the pH to 12.	Tier 1: 1000 mL Tier 2: 750 mL (initial) 1000 mL (final)	10, 20, 30, 45 and 60	07/01/2010
Celecoxib; Tramadol HCl	Tablet	II (Paddle)	75	0.1N Hydrochloric Acid + 2% SLS	1000	5, 10, 15, 20, 30, 45 and 60	07/07/2023
Cenobamate	Tablet			Refer to FDA's Dissolution Guidance, 2018			08/05/2024
Cephalexin	Capsule			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Cephalexin	Suspension			Develop a dissolution method			09/15/2023
Ceritinib	Tablet	I (Basket)	75	0.01 N HCl (degassed)	900	5, 10, 15, 20 and 30	04/22/2021
Ceritinib	Capsule	II (Paddle)	60	0.01 N HCl (degassed)	900	5, 10, 15, 20 and 30	08/27/2015
Cetirizine	Capsule (Soft-Gelatin)	II (Paddle)	50	25 mM pH 6.8 phosphate buffer	900	5, 10, 15, 20, 30 and 45	01/15/2015
Cetirizine HCl	Tablet (Orally Disintegrating)			Refer to USP			03/17/2016
Cetirizine HCl	Tablet (Regular & Chewable)			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Cetirizine HCl/Pseudoephedrine HCl	Tablet (Extended Release)	I (Basket)	100	0.1 N HCl	500	0.17, 0.25, 0.5, 1, 2, 6 and 8 hours	06/18/2007
Cevimeline HCL	Capsule			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Chlorambucil	Tablet	II (Paddle)	75	0.1 N HCl	900	10, 20, 30, and 45	08/17/2006
Chlordiazepoxide HCl/ Clidinium Bromide	Capsule			Develop a dissolution method			01/03/2024
Chlorhexidine Gluconate	Tablet (Dental)			Develop a method to characterize in vitro release			07/07/2022
Chloroquine Phosphate	Tablet			Refer to FDA's Dissolution Guidance, 2018			04/16/2020
Chlorothiazide	Suspension			Develop a dissolution method			03/07/2019
Chlorpheniramine Maleate	Tablet (Extended Release)	III (Reciprocating Cylinder)	27 dpm	Row 1: Test Fluid 1 (0.1N HCl) for 1st hour. Row 2: Test fluid 2 (Phosphate Buffer, pH 7.5) for 5th hour	Row 1: 250 mL. Row 2: 250 mL	1 hour for test fluid 1, and 4 hours for test fluid 2	07/25/2007
Chlorpheniramine Maleate/Codeine Phosphate	Tablet (Extended Release)	II (Paddle)	50	Simulated gastric fluid (SGF) without enzyme (pH 1.2)	900	0.5, 1, 2, 4, 6, 8 and 12 hours	10/20/2016
Chlorpheniramine Maleate/Ibuprofen/Phenylephrine HCl	Tablet	II (Paddle)	50	50 mM Potassium Phosphate Buffer, pH 6.5 (degassed)	900	5, 10, 15, 20 and 30	06/25/2015
Chlorpheniramine Maleate/Ibuprofen/Pseudoephedrine HCl	Tablet	II (Paddle)	50	0.05 M Phosphate Buffer, pH 6.5	900	10, 20, 30 and 45	02/20/2004
Chlorpheniramine Polistirex/ Codeine polistirex	Suspension (Extended Release)	II (Paddle)	50	Acid Stage: 0.1 N HCl; Buffer Stage: pH 6.8 Phosphate Buffer [500 mL 0.1 N HCl for 1 hour, followed by addition of 400 mL of 0.2M NaH2P04 to pH 6.8]	Acid Stage: 500 mL; Buffer Stage: 900 mL	Acid Stage: 1 hour; Buffer Stage: 1, 2, 4, 6, 8 and 12 hours	03/17/2016
Chlorpheniramine Polistirex/Hydrocodone Polistirex	Extended Release Oral Suspension	II (Paddle)	50	Simulated Gastric Fluid (SGF) at 37ºC ± 0.5ºC	495	1, 2, 3, 6, 8, 12, 16 and 24 hours	06/30/2011
Chlorpheniramine Polistirex/Hydrocodone Polistirex	Capsule (Extended Release)	II (Paddle)	50	Simulated Intestinal Fluid without enzyme	500	1, 4, 12, and 24 hours	11/25/2008
Chlorpromazine HCl	Tablet			Refer to USP			01/05/2012
Chlorthalidone	Tablet			Develop a dissolution method			01/03/2024
Chlorzoxazone	Tablet			Develop a dissolution method			01/03/2024
Cholic Acid	Capsule	II (Paddle) with sinker	100	Phosphate Buffer, pH 6.8	500 mL for 50 mg capsule; 900 mL for 250 mg capsule	5, 10, 15, 20 and 30	03/17/2016
Choline Fenofibrate	Capsule (Delayed Release)	II (Paddle)	50	Acid Stage: 0.05M Sodium Phosphate, pH 3.5 ± 0.05; Buffer Stage: 0.05 M Sodium Phosphate, pH 6.8 ± 0.05	Acid stage: 500; Buffer stage: 900	Acid stage: 120; Buffer stage: 15, 30, 60, 90, 120, 240 and 360	07/01/2010
Ciclopirox	Topical Suspension			Develop a method to characterize in vitro release			03/25/2010
Cilostazol	Tablet			Develop a dissolution method			09/15/2023
Cimetidine	Tablet			Refer to USP			11/30/2023
Cinacalcet HCl	Tablet	II (Paddle)	75	0.05 N HCl	900	10, 20, 30 and 45	01/26/2006
Ciprofloxacin	Injectable Suspension [Otic]	IV (Flow through cell-closed loop) / 22 mm	Flow @ 6 mL/min	50 mM Acetate Buffer, pH 4.5 @37°C ± 0.5 [use glass beads; sample volume: 100 μl]	480	5, 10, 15, 20, 30, 45, 60 and 75	03/17/2016
Ciprofloxacin	Oral Suspension	II (Paddle)	100	0.05 M Acetate Buffer with 0.025% Brij35 (polyoxyethylene lauryl ether), pH 4.5	900	10, 20, 30 and 45	03/25/2010
Ciprofloxacin HCl	Tablet			Refer to USP			09/02/2010
Ciprofloxacin HCl	Tablet (Extended Release)	I (Basket)	100	0.1 N HCl	900	1, 2, 4, and 7 hours or until at least 80% released	01/14/2008
Ciprofloxacin HCl/Hydrocortisone	Otic Suspension			Develop a method to characterize in vitro release			09/01/2011
Ciprofloxacin/Ciprofloxacin HCl (AB)	Tablet (Extended Release)	II (Paddle)	50	0.1 N HCl	900	15, 30, 60, and 120	01/14/2008
Ciprofloxacin/Dexamethasone	Otic Suspension			Develop a method to characterize in vitro release			03/17/2016
Citalopram	Capsule			Refer to FDA's Dissolution Guidance, 2018			07/07/2023
Citalopram HBr	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Citalopram Hydrobromide	Capsule	II (Paddle)	50	0.1 N HCl	900	10, 20, 30 and 45	10/06/2008
Cladribine	Tablet	II (Paddle)	50	Phosphate Buffer, pH 6.8  (deaerated)	900	5, 10, 15, 20 and 30	05/12/2022
Clarithromycin	Suspension	II (Paddle)	50	0.05 M Phosphate Buffer, pH 6.8	900	10, 20, 30, 45 and 60	01/23/2004
Clarithromycin	Tablet (Extended Release)			Refer to USP			10/06/2008
Clarithromycin	Tablet			Refer to USP			07/25/2007
Clindamycin HCl	Capsule			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Clobazam	Film	V (Paddle over Disk), with 56 mm, 40 mesh stainless steel disk.	75	0.1 N HCl	900	2, 5, 10, 15, 20 and 30	04/22/2021
Clobazam	Tablet	II (Paddle)	75	0.1 N HCl (degassed)	900	5, 10, 20, 30, 45 and 60	07/31/2013
Clobazam	Oral Suspension	II (Paddle)	75	0.1 N HCl (degassed)	900	5, 10, 15, 20, 25 and 30	07/31/2013
Clomiphene Citrate	Tablet			Develop a dissolution method			01/03/2024
Clomipramine HCl	Capsule			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Clonazepam	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Clonazepam	Tablet (Orally Disintegrating)			Develop a dissolution method			09/15/2023
Clonidine	Transdermal			Refer to USP			02/18/2009
Clonidine ( 0.1 mg)	Tablet (Extended Release)	II (Paddle) with sinker	50	Acid stage: 0.01 N HCl; Buffer stage: Phosphate Buffer, pH 7.0	Acid stage: 500; Buffer stage: 500	Acid stage: 1 and 2 hours; Buffer stage: 1, 2, 4, 6, 10, 14 and 16 hours	01/26/2012
Clonidine ( EQ. 0.17 mg and EQ. 0.26 mg)	Tablet (Extended Release)	II (Paddle)	50	500 mL 0.1N HCl for the 1st hour, then add 400 mL 0.27M Sodium Phosphate (Dibasic) buffer solution	Acid stage: 500; Buffer stage: 900	1, 2, 3, 6, 9, 12, 16, 20 and 24 hours	07/01/2010
Clonidine HCl	Tablet			Refer to USP			06/18/2007
Clonidine HCl (0.1 mg & 0.2 mg)	Tablet (Extended Release)	II (Paddle) with sinker	50	Acid stage: 0.01 N HCl; Buffer stage: Phosphate Buffer, pH 7.0	Acid stage: 500; Buffer stage: 500	Acid stage: 1 and 2 hours; Buffer stage: 1, 2, 4, 6, 10, 14 and 16 hours	08/27/2015
Clopidogrel Bisulfate	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Clorazepate Dipotassium	Tablet			Refer to USP			01/31/2013
Clotrimazole	Tablet (Vaginal)	II (Paddle)	50	0.1 N HCl	900	10, 20, 30 and 45	01/24/2004
Clotrimazole	Lozenge			Refer to USP			10/06/2008
Clozapine	Suspension	II (Paddle)	50	Acetate Buffer (pH 4.0)	900	5, 10, 15, 20 and 30	05/28/2015
Clozapine	Tablet (Orally Disintegrating)	II (Paddle	50 RPM (12.5 mg, 25 mg and 100 mg); 75 RPM (150 mg and 200 mg)	pH 4.5 Acetate Buffer	900	5, 10, 15, 20, and 30	06/09/2011
Clozapine	Tablet			Refer to USP			07/21/2011
Cobicistat	Tablet	II (Paddle)	75	50 mM Sodium Acetate Buffer, pH 4.5	900	5, 10, 15, 20 and 30	08/27/2015
Cobicistat (Cobi)/ Darunavir Ethanolate (Drv)	Tablet	Cobi: II (Paddle): Drv: II (Paddle)	Cobi: 75; Drv:75	Cobi: 0.05 M Citrate Phosphate Buffer, pH 4.2; Drv: 0.05 M Sodium Phosphate Buffer, pH 3.0, 2% Tween 20	Cobi: 900 mL; Drv: 900 mL	Cobi: 5, 10, 15, 20 and 30; Drv: 10, 15, 20, 30 and 45	10/20/2016
Cobicistat/Elvitegravir/ Emtricitabine/Tenofovir Alafenamide Fumarate	Tablet	II (Paddle)	100	0.05 M sodium citrate buffer pH 5.5 containing 2.0% w/v polysorbate 80	1000	5, 10, 15, 20 and 30	10/20/2016
Cobicistat/Elvitegravir/Emtricitabine/Tenofovir Disoproxil Fumarate	Tablet	II (Paddle) with sinker	100	0.01 N HCl with 2% w/w Polysorbate 80	1000	5, 10, 15, 20 and 30	06/25/2015
Cobimetinib Fumarate	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Codeine Sulfate	Tablet			Refer to USP			09/01/2011
Colchicine	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Colchicine	Capsule			Develop a dissolution method			09/15/2023
Colesevelam HCl	Tablet			Disintegration Testing as per USP <701> in various media such as simulated gastric fluid and simulated intestinal fluid.			10/28/2010
Crizotinib	Capsule	I (Basket)	100	0.1N HCl (degassed)	900	5, 10, 15, 30 and 45	04/14/2016
Crofelemer	Tablet (Delayed Release)	II (Paddle)	75	Acid stage: 0.1 N HCl; Buffer stage: Sodium phosphate buffer, pH 6.8	Acid stage: 750; Buffer stage: 1000	Acid stage: 2 hours; Buffer stage: : 5, 10, 20, 30 and 45 minutes	06/02/2016
Cyclobenzaprine	Capsule (Extended Release)			Refer to USP			10/20/2016
Cyclobenzaprine HCl	Tablet			Refer to USP			07/25/2007
Cyclophosphamide	Tablet			Develop a dissolution method			09/15/2023
Cycloserine	Capsule			Develop a dissolution method			01/03/2024
Cyclosporine (100 mg) (AB1)	Capsule (Liquid filled)	II (Paddle)	75	0.1 N HCl containing 4 mg of N,N-dimethydodecylamine-N-oxide per mL	1000	10, 20, 30, 45, 60 and 90	01/14/2008
Cyproheptadine HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Cysteamine Bitartrate	Granule (Delayed Release)	I (Basket	75 rpm (for 75 mg strength); 150 rpm (for 300 mg strength)	Acid Stage: 0.1 N HCl; Buffer Stage: 0.2M Sodium Phosphate buffer, pH 6.8	Acid Stage: 1000; Buffer Stage:1000	Acid Stage: 120; Buffer Stage: 5, 10, 15, 20 and 30	08/27/2020
Cysteamine Bitartrate	Capsule	I (Basket)	75	0.1 N HCl	900	10, 20, 30 and 45	01/24/2004
Cysteamine Bitartrate	Capsule (Delayed Release)	I (Basket)	75	Acid stage: 0.1N HCl; Buffer stage: 0.05 M Sodium Phosphate buffer, pH 6.8	Acid stage: 1000; Buffer stage: 1000	Acid stage: 2 hours; Buffer stage: : 5, 10, 15, 20 and 30 minutes	08/27/2015
Dabigatran Etexilate Mesylate	Capsule	I (Basket) for 75 strength: I (Basket with modified diameter of 24.5 mm) for 150 mg strength:	100	0.01 N HCl (pH 2.0)	900	10, 20, 30, and 45	09/22/2011
Dabrafenib Mesylate	Capsule	II (Paddle)	65	0.2% Cetyl trimethylammonium bromide (CTAB) in 0.1N HCl	900	10, 15, 20, 30 and 45	05/28/2015
Daclatasvir Dihydrochloride	Tablet	II (Paddle)	75	Phosphate Buffer, pH 6.8  with 0.75% Brij 35	1000	10, 15, 20, 30 and 45	03/17/2016
Dalfampridine	Tablet (Extended Release)	II (Paddle)	50	Phosphate Buffer, pH 6.8	900	0.5, 1, 2, 4, 6, 8, 10 and 12 hours	06/07/2012
Danazol	Capsule			Refer to USP			06/18/2007
Dantrolene Sodium	For suspension (Intravenous )	II (Paddle)	50	0.5% Benzalkonium Chloride in water	900	0.5, 1, 2, 3, 5 and 10	03/02/2017
Dantrolene Sodium	Capsule	I (Basket)	100	0.5% Hyamine 10X in water, adjust to pH 6.8 with 0.1 N KOH or 0.1 N HCl	900	10, 20, 30, 40 and 60	01/27/2004
Dapagliflozin Propanediol	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Dapagliflozin Propanediol/ Metformin HCl	Tablet (Extended Release)	I (Basket- 20 mesh)	100	Phosphate Buffer, pH 6.8	1000	Dapagliflozin: 5, 10, 15, 20, 30 and 45 minutes: Metaformin: 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours	08/27/2015
Dapagliflozin/Saxagliptin HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018			08/27/2020
Daprodustat	Tablet	II (Paddle)	50	30 mM Phosphate Buffer, pH 6.8	500 for 1 mg; 900 for 2, 4, 6 and 8 mg	5, 10, 15, 20, 25, 30, 45 and 60	05/31/2024
Dapsone	Gel (Topical)			Develop a method to characterize in vitro release			07/28/2016
Dapsone	Tablet			Refer to USP			12/23/2010
Daridorexant HCl	Tablet	II (Paddle)	75	pH 1.2 (NaCl/HCl)	900	5, 10, 15 and 30	05/18/2023
Darifenacin Hydrobromide	Tablet (Extended Release)	I (Basket)	100	0.01N HCl	900	1, 4, 8, 12, 16, 20 and 24 hours	01/20/2006
Darolutamide	Tablet	II (Paddle)	75	1% sodium lauryl sulfate (SLS) in 0.01N HCl	1000	15, 30, 45, 60, 75 and 90	01/30/2020
Darunavir Ethanolate	Oral Suspension	II (Paddle)	75	0.05% Polysorbate 20 in 0.05M Phosphate Buffer, pH 6.8	900	5, 10, 15, 20, 30 and 45	06/25/2015
Darunavir Ethanolate	Tablet	II (Paddle)	75	2% Tween-20 in 0.05 M Sodium Phosphate Buffer, pH 3.0	900	10, 20, 30, and 45	09/13/2007
Darunavir(Drv)/Cobicistat (Cobi)/Emtricitabine (Emt)/Tenofovir Alafenamide Fumarate (Taf)	Tablet	II (Paddle)	75	Drv: 0.05 M Sodium Phosphate Buffer, pH 3.0, 2% Tween 20; For Cobi, Emt and Taf: Citrate Phosphate Buffer, pH 4.2	900	Drv: 10, 15, 20, 30 and 45; For Cobi, Emt and Taf: 5, 10, 15, 20 and 30	07/07/2022
Dasabuvir Na/ Ombitasvir/Paritaprevir/Ritonavir	Tablet (Extended Release)	III (Reciprocating Cylinder [40 mesh (for bottom and top of the inner tube)]	25 dpm	15 mM hexadecyltrimethylammonium bromide (CTAB) in 0.03M Sodium Phosphate Buffer, pH 6.8	250	Ombitasvir/ Paritaprevir/ Ritonavir: 10, 15, 20, 30, 45, 60 and 90 minutes;Dasabuvir: 1, 2, 3, 6, 9, 12, 15, 18, 21 and 24 hours	10/20/2016
Dasatinib	Tablet	II (Paddle)	60	pH 4.0 Acetate buffer containing 1% Triton X-100	1000	10, 15, 30 and 45	10/30/2009
Deferasirox	Tablet (for Oral Suspension)	II (Paddle)	50	Phosphate buffer pH 6.8 with 0.5% Tween 20	900	10, 20, 30 and 45	06/21/2006
Deferasirox	Tablet	II (Paddle)	75	0.5% Tween 20 in Phosphate Buffer, pH 6.8	900	5, 10, 15, 20 and 30	03/17/2016
Deferasirox	Granule	II (Paddle)	75	Phosphate Buffer, pH 6.8 with 0.5% Tween 20	900	5, 10, 15, 20 and 30	11/02/2017
Deferiprone	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Deferiprone (1 GM)	Tablet	I (Basket)	100	Acidic Stage: 0.1 N HCl, Buffer Stage: 0.05 M Phosphate buffer, pH 6.8.		Acid Stage: 2 hours; Buffer Stage: 1, 2, 3 and 4 hours	07/07/2022
Deflazacort	Suspension	II (Paddle)	25	Simulated Gastric Fluid, pH 1.2	500	5, 10, 15 and 30	07/07/2023
Deflazacort	Tablet	II (Paddle)	50	50 mM Phosphate buffer w/0.3% SLS, pH 6.8	500	5, ,15, 30 and 45	07/07/2023
Degarelix Acetate	Powder for Injection			Develop a method to characterize in vitro release			10/06/2023
Delafloxacin Meglumine	Tablet	II (Paddle)	60	0.05 M Phosphate Buffer, pH 7.4 (degassed)	900	5, 10, 15, 20 and 30	11/16/2017
Delavirdine Mesylate	Tablet	II (Paddle)	50	0.05 M Phosphate Buffer, pH 6.0 containing 0.6% w/v SDS	900	10, 20, 30, 45 and 60	12/03/2007
Demeclocycline HCl	Capsule			Develop a dissolution method			01/03/2024
Demeclocycline HCl	Tablet			Develop a dissolution method			01/03/2024
Desipramine HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Desloratadine	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Desloratadine	Tablet (Orally Disintegrating)	II (Paddle)	50	0.1 N HCl	900	3, 6, 10, 15	06/18/2007
Desloratadine/Pseudoephedrine Sulfate (2.5 mg/120 mg)	Tablet (Extended Release)	II (Paddle)	50	First hour: 0.1 N HCl; After 1 hour: 0.1M Potassium Phosphate Buffer pH 7.5	1000	For Desloratadine: 10, 20, 30 and 45; For Pseudoephedrine Sulfate: 1, 2, 6 and 8 hours	04/02/2009
Desloratadine/Pseudoephedrine Sulfate (5 mg/240 mg)	Tablet (Extended Release)	II (Paddle)	50	First hour: 0.1 N HCl; After 1 hour: 0.1M Potassium Phosphate Buffer pH 7.5	1000	For Desloratadine: 10, 20, 30 and 45; For Pseudoephedrine Sulfate: 1, 2, 4, 8, 16 and 24 hours	04/02/2009
Desmopressin Acetate	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Desogestrel/Ethinyl Estradiol	Tablet			Refer to USP			11/04/2008
Desvenlafaxine Succinate	Tablet (Extended Release)			Develop a dissolution method			09/15/2023
Deucravacitinib	Tablet	II (Paddle)	75	50 mM potassium phosphate buffer, pH 6.3 with 0.01% (w/v) Brij®35	1000	10, 20, 30, 45 and 60	11/30/2023
Deutetrabenazine	Tablet	II (Paddle) over a disk (62 mm with 16 mesh)	75	pH 3.0 Acid Phthalate Buffer	500	0.5, 1, 1.5, 2, 3, 4, 5 and 6 hours	11/02/2017
Dexamethasone	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Dexamethasone	Implant (Intravitreal)	VII (with reciprocating 50 mesh baskets)	30 cycles per min	Phosphate Buffered Saline containing 0.05 g/L sodium dodecyl sulfate at 45 ± 0.5°C	30	12, 24, 48, 72, 96, 120, 144, 168, 192, 216 and 240 hours	10/21/2010
Dexamethasone/Neomycin Sulfate/ Polymyxin B Sulfate	Ophthalmic Suspension			Develop a method to characterize in vitro release			02/15/2018
Dexamethasone/Tobramycin	Ophthalmic Suspension			Develop a method to characterize in vitro release			04/02/2009
Dexbrompheniramine Maleate/Pseudoephedrine Sulfate	Tablet (Extended Release)	III (Reciprocating Cylinder)	12 dpm	0.02N HCl (2 hours) followed by 0.05M Phosphate Buffer pH 7.5	250	0.5, 1, 2, 3, 4, 6 and 8 hours	05/28/2015
Dexlansoprazole	Capsule (Delayed Release)	I (Basket)	100	Acid Stage: 0.1 N HCl, Buffer Stage: pH 7.0 Phosphate Buffer with 5 mM SLS	Acid Stage: 500; Buffer stage: 900	Acid Stage: 120; Buffer Stage: 10, 20, 40, 50, 60 , 75, 105 and 120	08/05/2010
Dexlansoprazole	Tablet (Delayed Release, Orally Disintegrating)	I (Basket -100 mesh)	100	Acid Stage: 0.1 N HCl; Buffer Stage: pH 7.2 Phosphate Buffer with 5 mM Sodium lauryl sulfate	Acid Stage: 500 mL; Buffer Stage: 900 mL	Acid Stage: 120; Buffer Stage: 10, 15, 20, 30, 50, 60, 75 and 90	07/28/2016
Dexmedetomidine HCl	Sublingual Film	V (Paddle over disk)	50	Simulated saliva	500	5, 10, 15, 20 and 30	05/31/2023
Dexmethylphenidate HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Dexmethylphenidate HCl	Capsule (Extended Release)	I (Basket)	100	First 2 hours: 0.01 N HCl, Hours 2-10: Phosphate Buffer, pH 6.8	Acid: 500, Buffer: 500	0.5, 1, 2, 4, 6, and 10 hours	01/14/2008
Dexmethylphenidate HCl; Serdexmethylphenidate Chloride	Capsule			Refer to FDA's Dissolution Guidance, 2018			05/18/2023
Dextroamphetamine	Transdermal System	VI (Cylinder)	50	50 mM potassium phosphate buffer, pH 6.8		5, 10, 15, 30, 45, 60, 120, 180, 240, 300 and 360	11/30/2023
Dextroamphetamine Sulfate	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Dextroamphetamine Sulfate	Tablet			Develop a dissolution method			09/15/2023
Dextroamphetamine Sulfate	Capsule (Extended Release)	I ( Basket)	100	0.1 N HCl	500	1, 4, 8 and 12 hours	11/25/2008
Dextromethophan HBr/Guaifenesin	Tablet (Extended Release)	I (Basket)	50	0.01 N HCl	900	1, 2, 6, and 12 hours	11/25/2008
Dextromethorphan Hydrobromide/Quinidine Sulfate	Capsule	I (Basket)	100	pH 1.2, Simulated Gastric Fluid without enzyme	900	5, 10, 15, 20 and 30	01/05/2012
Dextromethorphan Polistirex	Suspension (Extended Release)	II (Paddle)	50	0.1 N HCl	500	30, 60, 90 and 180	10/06/2008
Diazepam	Tablet			Refer to USP			07/25/2007
Diazoxide	Oral suspension			Develop a dissolution method			02/14/2014
Diclofenac	Capsule	I (Basket)	100	10 mM Citrate Buffer pH 5.5 with 0.05% Sodium Dodecyl Sulfate (SDS)	900	5, 10, 20, 30 and 45	06/25/2015
Diclofenac Epolamine	Topical patch	V (Paddle over Disk) with a watchdish (a diameter of 6 cm)	50	pH 6.8 phosphate buffer at 32 ± 0.5°C	500	15, 30, 45, 60, 90, 120 and 180	10/21/2010
Diclofenac Potassium	Powder for Oral Solution	II (Paddle	75	0.05M phosphate buffer (TriSodium Phosphate Dodecahydrate in 0.1 N HCl and pH adjusted to 6.8)	400	2.5, 5, 7.5 and 10	10/21/2010
Diclofenac Potassium	Capsule	II (Paddle	50	50 mM Phosphate buffer pH 6.8	900	10, 15, 20, 30 and 45	10/21/2010
Diclofenac Potassium	Tablet	II (Paddle)	50	SIF without enzyme	900	10, 20, 30, 45, 60 and 90	01/27/2004
Diclofenac Sodium	Tablet (Extended Release)			Refer to USP			06/10/2009
Diclofenac Sodium	Tablet (Delayed Release)			Refer to USP			06/10/2009
Diclofenac Sodium/Misoprostol Enteric Coated	Tablet (Delayed Release)	II (Paddle) (diclo)	100 (diclo)	Diclofenac: Acid Stage: 0.1 N HCl Buffer Stage: 750ml 0.1N HCL+250ml 0.2M phos.buffer, pH 6.8 (Method A) Misoprostol: Develop a dissolution method	Diclo: Acid: 750 Buffer:1000	Diclo.: 120 (acid) 15, 30, 45 and 60 (Buffer)	09/15/2023
Dicloxacillin Sodium	Capsule			Develop a dissolution method			01/03/2024
Dicyclomine Hydrochloride	Tablet			Refer to USP			05/12/2022
Didanosine	Tablet (Chewable)			Develop a dissolution method			09/15/2023
Didanosine	Capsule (Delayed Release Pellets)	I (Basket)	100	Acid stage: 0.1 N HCl; Buffer stage: 0.1 N HCl:0.2M Tribasic Sodium Phosphate (3:1), pH 6.8	1000	Acid stage: 60, 90 and 120; Buffer stage: 10, 20, 30, 45 and 60	01/26/2004
Dienogest/Estradiol Valerate	Tablet			Develop a dissolution method			09/15/2023
Diethylpropion HCl	Tablet (Extended Release)			Develop a dissolution method			09/15/2023
Diflunisal	Tablet			Refer to USP			04/15/2008
Digoxin	Tablet			Refer to USP			06/18/2007
Diltiazem HCl	Tablet (Extended Release)	II (Paddle)	100	Phosphate Buffer, pH 5.8	900	2, 8, 14, and 24 hours	02/19/2008
Diltiazem HCl	Capsule (Extended Release)			Develop a dissolution method			01/03/2024
Dimethyl Fumarate	Capsule  (Delayed Release)	II (Paddle)	100	Acid stage: 0.1 N HCl; Buffer stage: pH 6.8 Phosphate Buffer	Acid stage: 500; Buffer stage: 500	Acid stage: 2 hours; Buffer stage: 5, 10, 20, 30 and 45	06/02/2016
Dinoprostone	Vaginal Insert (Extended Release)			Develop a dissolution method			09/15/2023
Dinoprostone	Vaginal Suppository			Develop a method to characterize in vitro release			10/04/2012
Diphenhydramine Citrate/Ibuprofen	Tablet	II (Paddle)	50	50 mM Phosphate Buffer, pH 6.5	900	10, 20, 30 and 45	01/14/2008
Diphenhydramine HCl/Ibuprofen	Capsule	I (Basket)	100	200 mM Phosphate Buffer, pH 7.2	900	10, 20, 30 and 45	01/14/2008
Dipyridamole	Tablet			Refer to USP			06/18/2007
Diroximel Fumarate	Capsule (Delayed Release)	II (Paddle) with sinker	75	Acid Stage: 0.1 N HCl; Buffer Stage: Na.Phosphate Buffer, pH 6.5		Acid Stage: 120; Buffer Stage: 10, 20, 30, 45, 60, 75 and 90	04/02/2020
Disopyramide Phosphate	Capsule			Develop a dissolution method			01/03/2024
Disopyramide Phosphate	Capsule (Extended Release)			Refer to USP			11/04/2008
Disulfiram	Tablet	II (Paddle)	100	2% SDS	900	15, 30, 45, 60, 75, 90, 105, and 120	06/18/2007
Divalproex Sodium	Tablet (Delayed Release)			Refer to USP			07/25/2007
Divalproex Sodium	Tablet (Extended Release)			Refer to USP			06/30/2016
Divalproex Sodium	Capsule (Delayed Release)			Refer to USP			06/30/2016
Dofetilide	Capsule			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Dolasetron Mesylate	Tablet			Develop a dissolution method			01/03/2024
Dolutegravir Na/Rilpivirine HCl	Tablet	II (Paddle)	75	1.0 % Tween 20 in 0.01 M HCl, pH 2.0	900	10, 15, 20, 30, 45 and 60	02/08/2018
Dolutegravir Sodium (10 mg)	Tablet	II (Paddle)	50	0.01M pH 6.8 phosphate buffer	900	5, 10, 15, 20, 30 and 45	10/18/2018
Dolutegravir Sodium (25 mg)	Tablet	II (Paddle)	50	0.01M pH 6.8 phosphate buffer containing 0.15% w/v sodium dodecyl sulfate (SDS)	900	5, 10, 15, 20, 30 and 45	10/18/2018
Dolutegravir Sodium (50 mg)	Tablet	II (Paddle)	50	0.01M pH 6.8 phosphate buffer containing 0.25% w/v sodium dodecyl sulfate (SDS)	900	5, 10, 15, 20, 30 and 45	10/18/2018
Donepezil HCl/Memantine HCl	Capsule (Extended Release)	I (Basket)	100	pH 1.2 NaCl/HCl buffer	900	Donepezil: 5, 10, 15, 20 and 30 minutes; Memantine: 1, 2, 3, 4, 6, 8, 10 and 12 hours	05/28/2015
Donepezil HCl	Tablet (Orally Disintegrating (ODT))	II (Paddle)	50	0.1 N HCl	900	10, 20, 30 and 45	03/04/2006
Donepezil HCl	Transdermal	V (Paddle over disk) with Transdermal System Holding Wire Screen (TSHWR)	100	0.02 M sodium acetate buffer, pH 4.5 at 32°C	900	1,8,24,48 and 168 hours	05/18/2023
Donepezil HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Donepezil HCl (23 mg)	Tablet	II (Paddle	50	0.05 M Phosphate Buffer, pH 6.8	900	1, 2, 3, 4, 6, 8 and 10 hours	12/23/2010
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate	Tablets	II (Paddle)	75	25 mM Phosphate Buffer, pH 6.8 with 3% Polysorbate 80	900	5, 10, 15, 20, 30, 45, 60 and 90	10/06/2023
Doxazosin Mesylate	Tablet	II (Paddle)	50	0.01 N HCl	900	10, 20, 30, 45 and 60	01/27/2004
Doxazosin Mesylate	Tablet (Extended Release)	II (Paddle)	75	SGF without enzyme	900	1, 2, 4, 6, 8, 12 and 16 hours	01/03/2007
Doxepin HCl	Tablet	II (Paddle)	50	Simulated Gastric Fluid w/o enzyme (pH 1.1-1.3)	900	5, 10, 15, 20, 30 and 45	09/02/2010
Doxepin HCl	Capsule			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Doxepin HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Doxercalciferol	Capsule			Develop a quantitative rupture test			06/03/2008
Doxorubicin HCl	Injectable (Liposomal)			Develop a method to characterize in vitro release, starting at pH 6.00 ± 0.05 and at 47ºC ± 0.5ºC. Replicate for 12 dosage vials.			10/04/2012
Doxycycline	Capsule (Delayed Release)	II (Paddle)	75	Dilute HCl, pH 1.1 for 2 hours and then add 200 mL of 0.1 N NaOH in 200 mM Phosphate Buffer. Adjust pH to 6.0 using 2 N HCl and/or 2N NaOH	Acid stage: 750; Buffer stage: 950	1, 2, 2.5 , 3 and 4 hours	10/06/2008
Doxycycline	Suspension	II (Paddle)	25	0.01 N HCl	900	5, 10, 15 and 20	09/03/2008
Doxycycline Calcium	Suspension			Develop a dissolution method			03/07/2019
Doxycycline Hyclate	Capsule			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Doxycycline Hyclate	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Doxycycline Hyclate ( 120 mg and 60 mg)	Tablet (Delayed Release)	I (Basket)	100	Acid stage: 0.06 N HCl; Buffer stage: Neutralized Phthalate Buffer, pH 5.5	Acid stage: 900 mL; Buffer stage: 900 mL	Acid stage: 10, 20, 30, 45 and 60; Buffer stage: 5, 10, 15, 20, 30 and 45	03/27/2018
Doxycycline Hyclate ( 150 mg and 75 mg)	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Doxycycline Hyclate ( 200 mg, 150 mg, 100 mg, 80 mg and 75 mg)	Tablet (Delayed Release)			Refer to USP			05/28/2015
Doxycycline Hyclate ( 50 mg)	Tablet (Delayed Release)	I (Basket)	100	Acid stage: 0.06 N HCl; Buffer stage: Neutralized Phthalate Buffer, pH 5.5	900	Acid stage: 5, 10, 15, 20 and 30; Buffer stage: 5, 10, 15, 20 and 30	05/28/2015
Doxylamine Succinate/Pyridoxine HCl	Tablet (Extended Release)	II (Paddle)	100	Acid stage: 0.1 N HCl: Buffer stage: 0.2M sodium phosphate buffer pH 6.8	Acid stage: 1000 mL; Buffer stage: 1000 mL	Acid stage: 5, 10, 15, 30, 60, 120; Buffer stage: 5, 10, 15, 20 and 30	01/19/2017
Dronabinol	Capsule			Develop a dissolution method; (In addition, the USP capsule rupture test should also be conducted)			09/15/2023
Dronedarone HCl	Tablet	II (Paddle) with sinker	75	pH 4.5 Phosphate buffer	1000	10, 15, 20, 30, 45, 60, 90 and 120	02/25/2015
Drospirenone/Estetrol	Tablet	II (Paddle)	50	Phosphate Buffer pH 6.8	900	5,10, 15, 20 and 30	03/30/2023
Drospirenone/Estradiol	Tablet			Develop a dissolution method			09/15/2023
Drospirenone/Ethinyl Estradiol	Tablet			Develop a dissolution method			01/03/2024
Drospirenone/Ethinyl Estradiol/Levomefolate Calcium	Tablet	II (Paddle)	50	Phosphate buffer pH 6.8, saline with 0.03 % ascorbic acid	900	5, 10, 15, 20 and 30	07/28/2016
Droxidopa	Capsule			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Duetetrabenazine	Tablet, Extended Release	II (Paddle) with sinker	75	50 mM potassium biphthalate buffer, pH 3.0	500	2, 4, 6, 8, 10, 12. 16 and 20 hours	11/30/2023
Duloxetine HCl	Capsule (Delayed Release)			Refer to USP			03/17/2016
Dutasteride	Capsule (Soft-Gelatin)	II (Paddle)	50	Tier I: Dissolution Medium: 0.1 N HCI with 2% (w/v) sodium dodecyl sulfate (SDS) (900 mL) Tier II: Dissolution Medium: 0.1 N HCI with pepsin (as per USP) (450 mL) for the first 25 minutes, followed by addition of 0.1 N HCI with SDS (4% w/v) (450 mL) for the remainder of the dissolution test.	900	15, 30, 45 and 60	08/05/2010
Dutasteride/Tamsulosin HCl	Capsule	Dutasteride: II (Paddle) with sinker. Tamsulosin: II (Paddle)	Dutasteride: 75 Tamsulosin: 50	Dutasteride::Tier I: Dissolution Medium: 1%w/v cetyltrimethylammonium bromide (CTAB) in 0.1 N HCl. Tier II: Dissolution Medium: 1% w/v CTAB in 0.1 N HCl with 0.16% w/v pepsin. Tamsulosin:: Acid Stage (0-2 hrs): 0.1 N HCl. Buffer stage: Add 250 mL of 0.2 M Sodium Phosphate Tribasic, Dodecahydrate pH 6.8	Dutasteride: 900. Tamsulosin: Acid stage: 750; Buffer stage: 1000	Dutasteride: 15, 30, 45 and 60 minutes. Tamsulosin: Acid Stage: 2 hours Buffer stage: 0.5, 1, 2, 3, 5, 7 and 10 hours	01/26/2012
Edaravone	Suspension	II (Paddle)	75	pH 4.0 Acetate Buffer	900	5, 10, 15, 20 and 30	07/28/2022
Efavirenz	Capsule			Develop a dissolution method			09/15/2023
Efavirenz	Tablet			Develop a dissolution method			09/15/2023
Efavirenz 600 mg; Emtricitabine 200 mg; Tenofovir Disoproxil Fumarate 300 mg	Tablet			Develop a dissolution method			09/15/2023
Efavirenz/Lamivudine/Tenofovir Disoproxil Fumarate	Tablet			Develop a dissolution method			09/15/2023
Elacestrant Dihydrochloride	Tablet	II (Paddle)	75	0.01 N HCl	500 for 100 mg; 1000 for 400 mg	5, 10, 15, 30, 45 and 60	05/31/2024
Elagolix Sodium	Tablet	II (Paddle)	50	0.05 M Sodium Phosphate, pH 6.8	900	5, 10, 15, 20, 30 and 45	04/22/2021
Elagolix Sodium, Estradiol, Norethindrone Acetate; Elagolix Sodium	Capsule	Elagolix: I (Basket)	Elagolix: 100	Elagolix: 0.05M Sodium Phosphate pH 6.8		10, 15, 20, 25, 30, 45, 60 and 90	02/05/2024
Elbasvir/Grazoprevir	Tablet	I (Basket)	100	Phosphate Buffer, pH 6.8 with 0.45% (w/v) Polysorbate 80	900	10, 15, 20, 30, 45 and 60	07/28/2016
Eletriptan Hydrobromide	Tablet	I (Basket)	100	0.1 N HCl	900	5, 10, 15 and 30	04/02/2009
Elexacaftor, Ivacaftor, Tezacaftor [FDC:ELE+ IVA+ TEZ]; Ivacaftor [IVA]	Tablet/Tablet (Copackage)	II (Paddle)	FDC: ELE: 75/IVA: 65/TEZ:75; IVA: 75	FDA: ELE: 1.8% (v/v) Polysorbate 20 in 50 mM sodium phosphate, pH 6.8/ IVA: 0.4% (w/v) SLS in 50 mM sodium phosphate, pH 6.8/TEZ: 0.2% (w/v) SLS solution in 0.1N HCl; IVA: 1.8% (v/v) Polysorbate 20 in 50 mM sodium phosphate, pH 6.8	FDC: ELE: 900/IVA: 900/TEZ:900; IVA 900	5, 10, 15, 20 and 30	08/19/2021
Eliglustat Tartrate	Capsule			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Eltrombopag Olamine	Tablet	II (Paddle)	50	0.5% Polysorbate 80 in Phosphate Buffer, pH 6.8	900	10, 15, 20, 30, 45, and 60	06/07/2012
Eltrombopag Olamine	Suspension	II (Paddle)	50	50 mM potassium phosphate in water, pH 6.8 with 0.2% polysorbate 80	750	4, 8, 12, 15 and 20	10/20/2016
Eluxadoline	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Elvitegravir	Tablet	II (Paddle) with sinker	75	2.0% w/v Polysorbate 80 in 0.01 N HCl (pH 2.0) at 37 ºC	700 mL for 85 mg tablets; 1000 mL for 150 mg tablets 1000 mL for 150 mg tablets	10, 20, 30, 45 and 60	12/24/2015
Empagliflozin	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Empagliflozin/ Metformin HCl	Tablet (Extended Release)	I (Basket)	100	Phosphate Buffer, pH 6.8	900	Metformin: 1, 2, 4, 6, 8, 10 and 12 hours: Empagliflozin: 10, 15, 20, 30, 45 and 60 minutes;	01/19/2017
Empagliflozin/Linagliptin	Tablet	II (Paddle)	50	pH 6.8 Phosphate Buffer	900	10, 15, 20, 30 and 45	12/24/2015
Empagliflozin/Linagliptin/Metformin HCl	Tablet (Extended Release)	I (Basket)	100	Phosphate Buffer, pH 6.8	900	Metformin: 1, 2, 4, 6, 8, 10 and 12 hours: Empagliflozin and Linagliptin: 10, 15, 20, 30, 45 and 60 minutes	04/02/2020
Empagliflozin/Metformin HCl	Tablet	II (Paddle)	50	Phosphate Buffer, pH 6.8 (degas)	900	5, 10, 15, 20 and 30	06/30/2016
Emtricitabine	Capsule			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Emtricitabine/Rilpivirine HCl/Tenofovir Alafenamide Fumarate	Tablet	II (Paddle	75	Rilpivirine (RPV): 0.5% Polysorbate 20 in 0.01 N HCl; Emtricitabine (ETC) and Tenofovir alafenamide (TAF): 50 mM Sodium Citrate, pH 5.5,	RPV: 1000 mL; ETC and TAF: 500 mL	5, 10, 15, 20, 30 and 45	07/28/2016
Emtricitabine/Rilpivirine HCl/Tenofovir Disoproxil Fumarate	Tablet	II (Paddle) with sinker	75	0.5%(w/w) polysorbate 20 in 0.01N HCl (pH 2.0)	1000	Emtricitabine and Tenofovir: 5, 10, 15, 20 and 30; Rilpivirine: 10, 20, 30, 45, 60, 75, 90 and 120	01/15/2015
Emtricitabine/Tenofovir Alafenamide Fumarate	Tablet	II (Paddle	75	50 mM Sodium Citrate buffer, pH 5.5	500	5, 10, 15, 20, 30 and 45	07/28/2016
Emtricitabine/Tenofovir Disoproxil Fumarate	Tablet	II (Paddle)	50	0.01 N HCl	900	5, 10, 15, 30 and 45	01/03/2007
Enalapril Maleate	Tablet			Refer to USP			09/03/2008
Entacapone	Tablet	II (Paddle)	50	Phosphate Buffer, pH 5.5	900	10, 20, 30 and 45	01/29/2004
Entecavir	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Entrectinib	Capsule	II (Paddle) with Sinker	75	50 mM Potassium Phosphate, pH 6.0 with 0.374% w/v polysorbate 80	1000	15, 20, 30, 45, 60 and 75	08/19/2021
Enzalutamide	Capsule	II (Paddle) with sinker	50	Tier 1 Medium: 0.3% cetyl trimethyl ammonium bromide (CTAB) in 0.1 N HCl;Tier 2 Medium: 0.3% CTAB in 0.1 N HCl containing Pepsin 600,000 USP units/L.	900	10, 15, 20, 30 and 45	05/28/2015
Enzalutamide	Tablet	II (Paddle)	50	Phosphate Buffer, pH 7.5	900	5, 10, 15, 20, 30 and 45	05/12/2022
Eplerenone	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Eprosartan Mesylate	Tablet	II (Paddle)	75	0.2 M Phosphate Buffer, pH 7.5	1000	15, 30, 45 and 60	07/14/2008
Eprosartan Mesylate/Hydrochlorothiazide	Tablet	II (Paddle)	75	0.2 M Phosphate Buffer, pH 7.5	1000	10, 20, 30 and 45	02/19/2008
Ergocalciferol	Capsule	II (Paddle)	100	0.5 N NaOH with 10% Triton-X-100	500	15, 30, 45, 60 and 90	08/05/2010
Erlotinib HCl	Tablet	II (Paddle)	75	0.02% Tween 80 in 0.01 N HCl	1000	5, 10, 15, 20, 30 and 45	10/18/2018
Erythromycin	Tablet (Delayed Release)			Refer to USP			10/31/2013
Erythromycin	Tablet			Refer to USP			12/24/2015
Erythromycin Ethylsuccinate	Suspension	II (Paddle)	75	Monobasic Sodium Phosphate, pH 6.8 Buffer with 1% SLS Buffer w/ 1% SLS	900	10, 20, 30, 45 and 60	01/27/2004
Erythromycin Ethylsuccinate	Tablet			Refer to USP			04/22/2021
Erythromycin Ethylsuccinate	Oral granule			Develop a dissolution method			06/30/2016
Erythromycin Ethylsuccinate/Sulfisoxazole Acetyl	Granules for Oral Suspension			Develop a dissolution method			09/02/2010
Escitalopram Oxalate	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Escitalopram Oxalate	Capsule			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Eslicarbazepine Acetate	Tablet	II (Paddle)	100	Acetate Buffer, pH 4.5	1000	5, 10, 15, 20, 30 and 45	08/27/2015
Esomeprazole Magnesium	Capsule (Delayed Release Pellets)			Refer to USP			08/27/2015
Esomeprazole Magnesium	Tablet (Delayed Release)	II (Paddle)	100	Acid stage: 0.1 N HCl; Buffer stage: Phosphate Buffer, pH 6.8	Acid stage: 300; Buffer stage: 1000	Acid stage: 120; Buffer stage: 10, 20, 30, 45 and 60	10/20/2016
Esomeprazole Magnesium	For Oral Suspension (Delayed Release)	II (Paddle	100	Acid stage: 0.1 N HCl; Buffer stage: Sodium Phosphate Buffer, pH 6.8	Acid stage: 300; Buffer stage: 1000	Acid stage: 120; Buffer stage: 10, 20, 30, 45 and 60	09/02/2010
Esomeprazole Magnesium	Tablet (Orally Disintegrating, Delayed Release)	II (Paddle)	Acid stage: 100; Buffer stage: 75	Acid stage: 0.1 N HCl; Buffer stage: Phosphate Buffer, pH 6.8	Acid stage: 300; Buffer stage: 1000	Acid stage: 120; Buffer stage: 5, 10, 20, 30 and 45	04/22/2021
Estazolam	Tablet			Develop a dissolution method			09/15/2023
Esterified Estrogens	Tablet			Develop a dissolution method			09/15/2023
Estradiol	Vaginal Ring	Incubator shaker	130	0.9% Saline	250	1, 9, 16, 17, 18, 19, 45 days	01/03/2007
Estradiol	Vaginal Tablet	I (Basket)	40	Phosphate Buffer, pH 4.75 ± 0.05	500	1, 2, 3, 5, 8, 10 and 12 hours	07/21/2009
Estradiol (0.014 mg/24 hr)	Film, Transdermal (Extended Release)			Develop a method to characterize in vitro release			10/28/2010
Estradiol (0.025 mg/24 hr, 0.0375 mg/24 hr, 0.05 mg/24 hr, 0.06 mg/24 hr, 0.075 mg/24 hr and 0.1 mg/24 hr)	Film, Transdermal (Extended Release)			Develop a method to characterize in vitro release			10/28/2010
Estradiol (Test 1) (0.025 mg/24 hr, 0.0375 mg/24 hr, 0.05 mg/24 hr, 0.075 mg/24 hr and 0.1 mg/24 hr)	Film, Transdermal (Extended Release)	VI (Cylinder) attach the patch to a disk at the bottom of the cylinder	50	Water at 32 ± 0.5°C	0.025 mg/24 hr and 0.0375 mg/24 hr: 500 mL; 0.05 mg/24 hr, 0.075 mg/24 hr and 0.1 mg/24 hr: 900 mL	1, 2, 4, 6, 8, 10 and 12 hours	10/28/2010
Estradiol (Test 2) (0.05 mg/24 hr and 0.1 mg/24 hr)	Film, Transdermal (Extended Release)	V (Paddle over Disk) with a stainless steel disk	50	Water at 32 ± 0.5°C	900	6, 12, 18, 24, 36, 48, 60, 72 and 96 hours	10/28/2010
Estradiol (Test 3) 0.0375 mg/24 hr, 0.05 mg/24 hr, 0.075 mg/24 hr and 0.1 mg/24 hr)	Film, Transdermal (Extended Release)	VI (Cylinder) attach the patch to the cylinder with double-sided tape	50	Water at 32 ± 0.5°C	0.0375 mg/24 hr: 500 mL; 0.05 mg/24 hr, 0.075 mg/24 hr and 0.1 mg/24 hr: 900 mL	1, 2, 4, 6, 10, 12, 18, 24 and 36 hours	10/31/2013
Estradiol/Levonorgestrel	Film, Transdermal (Extended Release)	V (Paddle over Disk) attach the patch to the stainless steel plate with double-sided tape	50	30% Ethanol in water at 32±0.5°C	660	30, 60, 120, 180, 240 and 300	03/30/2023
Estradiol/Norethindrone Acetate	Film, Transdermal (Extended Release)	V (Paddle over Disk)	50	0.24% SDS in water at 32±0.5°C	0.05 mg/0.14 mg/24 hr: 500; 0.05mg/0.25 mg/24 hr: 900	1, 2, 4, 8, 12 and 14 hours	03/30/2023
Estradiol/Norethindrone Acetate	Tablet			Develop a dissolution method			01/03/2024
Estradiol/Norgestimate (1mg/0.09mg)	Tablet			Develop a dissolution method			09/15/2023
Estradiol/Progesterone	Capsule	III (Reciprocating Cylinder) [40 mesh for bottom and top of the inner tube]		3% sodium lauryl sulfate (SLS) in 0.1N HCl	250	10, 20, 30, 45 and 60	01/30/2020
Estramustine Phosphate Sodium	Capsule			Develop a dissolution method			09/15/2023
Estrogens Conjugated Synthetic A	Tablet			Develop a dissolution method			09/15/2023
Estrogens, Conjugated (EC)/Medroxyprogesterone Acetate (MPA)	Tablet	II (Paddle) with sinker	50	EC: 0.02 M Na Acetate Buffer (pH 4.5); MPA: Develop a dissolution method	900		09/15/2023
Estrogens, Conjugated Synthetic B	Tablet			Develop a dissolution method			09/15/2023
Eszopiclone	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Ethacrynic Acid	Tablet			Refer to USP			12/23/2010
Ethambutol HCl	Tablet			Develop a dissolution method			01/03/2024
Ethinyl Estradiol	Tablet			Refer to USP			09/22/2011
Ethinyl Estradiol/Ethynodiol Diacetate	Tablet			Develop a dissolution method			09/15/2023
Ethinyl Estradiol/Etonogestrel	Vaginal Ring			Develop a method to characterize in vitro release			01/31/2013
Ethinyl Estradiol/Levonorgestrel	Transdermal System	V (paddle over disk)	75	0.25% Hydroxypropyl-Beta-Cyclodextrin (HPCD) in Water (Deaerated ), 32±0.5˚C	500	1, 2, 4, 6, 12, 24, 36, 48, 72 and 96 hours	05/12/2022
Ethinyl Estradiol/Levonorgestrel	Tablet			Develop a dissolution method			01/03/2024
Ethinyl Estradiol/Norethindrone	Tablet (Chewable)	II (Paddle)	75	0.09% Sodium Lauryl Sulfate in 0.1 N HCl	500	10, 15, 20, 30 and 45	01/14/2008
Ethinyl Estradiol/Norethindrone	Tablet			Refer to USP			07/15/2009
Ethinyl Estradiol/Norethindrone Acetate	Tablet			Refer to USP			07/15/2009
Ethinyl Estradiol/Norethindrone Acetate	Capsule	II (Paddle)	100	Phosphate Buffer, pH 6.8, containing 0.07% w/v Triton X 100	900	5, 10, 20, 30, 45, 60 and 75	02/15/2018
Ethinyl Estradiol/Norethindrone Acetate [0.01mg,0.01 mg;1 mg]	Tablet (Chewable)	II (Paddle)	75	0.025 M Na Acetate Buffer with 0.15% Sodium Lauryl Sulfate [SLS] (pH 5.0) [degassed]	500	10, 15, 20, 30 and 45	12/24/2015
Ethinyl Estradiol/Norethindrone Acetate [0.02mg;1mg]	Tablet (Chewable)	II (Paddle)	75	0.025 M Sodium Acetate Buffer with 0.15% SLS, pH 5.0	600	10, 15, 20, 30 and 45	02/14/2014
Ethinyl Estradiol/Norgestimate	Tablet			Develop a dissolution method			09/15/2023
Ethinyl Estradiol/Norgestimate (AB)	Tablet			Develop a dissolution method			09/15/2023
Ethinyl Estradiol/Norgestrel	Tablet			Develop a dissolution method			09/15/2023
Ethinyl Estradiol; Norelgestromin	Film, Transdermal	Modified USP Type V (Paddle-over-disk)	50	0.1% Hydroxypropyl-beta-cyclodextrin at 32º C	900	0.25, 0.5, 1, 2, 4, 8, 12, 16, 20 and 24 hours	05/20/2009
Ethionamide	Tablet	I (Basket)	75	0.1 N HCl	900	10, 20, 30, 45 and 60	01/31/2013
Ethosuximide	Capsule			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Etidronate Disodium	Tablet			Develop a dissolution method			01/03/2024
Etodolac	Tablet			Refer to USP			01/14/2008
Etodolac	Tablet (Extended Release)			Refer to USP			06/24/2010
Etoposide	Capsule			Refer to USP			06/24/2010
Etravirine (200 mg)	Tablet	II (Paddle)	70	1.0 % Sodium lauryl sulfate (SLS) in 0.01 M HCl in two phases: Phase 1: 1000 mL of degassed 0.01 M HCl for 10 minutes. Phase 2: Add 800 mL of 2.25% SLS in 0.01 M HCl.	1000 (phase 1): 1800 (phase 2)	Phase 1: No Sampling. Phase 2: 5, 10, 20, 30, 45, 60 and 90	06/30/2011
Etravirine (25 and 100 mg)	Tablet	II (Paddle)	50	1.0 % Sodium lauryl sulfate (SLS) in 0.01 M HCl in two phases: Phase 1: 500 mL of degassed 0.01 M HCl for 10 minutes. Phase 2: Add 400 mL of 2.25% SLS in 0.01 M HCl.	500 (phase 1): 900 (phase 2)	Phase 1: No Sampling. Phase 2: 5, 10, 20, 30, 45, 60 and 90	08/14/2014
Everolimus	Tablet			Develop a dissolution method			09/15/2023
Exemestane	Tablet			Develop a dissolution method			09/15/2023
Exenatide Synthetic (2 mg)	For Suspension, Extended Release			Develop a method to characterize in vitro release			07/07/2022
Exenatide Synthetic (2 mg/0.85 mL)	Suspension, Extended Release			Develop a method to characterize in vitro release			07/07/2022
Ezetimibe	Tablet	II (Paddle)	50	0.45% SLS in 0.05 M Acetate Buffer, pH 4.5	500	10, 20, 30 and 45	01/14/2008
Ezetimibe/Simvastatin	Tablet	II (Paddle)	50	0.01 M Sodium Phosphate, pH 7.0/0.5% SDS	900	5, 10, 20 and 30	01/03/2007
Ezogabine	Tablet	II (Paddle)	75	0.01 N HCl	1000	5, 10, 15, 20 and 30	08/15/2013
Famciclovir	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Famotidine	Tablet (Orally Disintegrating)	II (Paddle)	50	0.1 M Phosphate Buffer, pH 4.5	900	2, 5, 10, 15 and 20	10/06/2008
Famotidine	Tablet (Chewable)	II (Paddle)	50	0.1 M Phosphate Buffer, pH 4.5	900	10, 20, 30, 45 and 60	01/29/2004
Famotidine	Tablet			Refer to USP			02/09/2023
Famotidine	Suspension	II (Paddle)	25 and 50	0.1 M Phosphate buffer, pH 4.5	900	10, 15, 30 and 45	11/25/2008
Famotidine/Calcium Carbonate/Magnesium Hydroxide	Tablet (Chewable)			Develop a dissolution method			12/15/2009
Famotidine/Ibuprofen	Tablet	II (Paddle)	50	0.05 M Phosphate Buffer, pH 7.2	900	5, 10, 15, 20, 30 and 45	08/15/2013
Febuxostat	Tablet	II (Paddle)	75	0.05 M Phosphate Buffer, pH 6.0	900	5, 10, 15, 20 and 30	08/15/2013
Fedratinib HCl	Capsule	I (Basket)	50	0.1 N HCl	900	5, 10, 15, 20 and 30	08/19/2021
Felbamate	Tablet			Develop a dissolution method			01/03/2024
Felbamate	Suspension			Develop a dissolution method			09/15/2023
Felodipine	Tablet (Extended Release)			Develop a dissolution method			01/03/2024
Fenofibrate	Capsule	II (Paddle)	75	Phosphate Buffer w/ 2% Tween 80 and 0.1% pancreatin, pH 6.8	900	15, 30, 45, 60, 90 and 120	02/19/2008
Fenofibrate	Capsule (Micronized)			Develop a dissolution method			09/15/2023
Fenofibrate (40 mg and 120 mg)	Tablet			Develop a dissolution method			09/15/2023
Fenofibrate (48 mg and 145 mg)	Tablet			Develop a dissolution method			09/15/2023
Fenofibrate (54 mg and 160 mg)	Tablet			Develop a dissolution method			09/15/2023
Fenofibric Acid	Tablet	II (Paddle)	75	Phosphate buffer, pH 6.8	900	5, 15, 30, 45 and 60	08/05/2010
Fenoprofen Calcium	Capsule			Refer to USP			11/25/2008
Fentanyl	Transdermal	VII (Reciprocating holder)- cylinder.	30 cycles per minute. amplitude of about 2m.	Equimolar mixture of 0.005 M phosphoric acid solution, and 0.005 M sodium phosphate, monobasic monohydrate (pH ~ 2.6). at 32° C. Change the test samples into fresh pre-equilibrated release medium at the time points indicated. Remove the protective liner and place the film onto a piece of nylon netting with adhesive facing the net. Secure the netting and transdermal system using nylon tie wraps at the top and bottom of the cylinder on the holder. The adhesive side faces towards the media.	250 mL for the 75 and 100 mcg/hr, 200 mL for the 50 mcg/hr and 150 mL for the 25 and 12.5 mcg/hr dosage strength.	0.5, 1, 2, 4 and 24 hours	06/09/2011
Fentanyl Citrate	Tablet (Sublingual)	II (Paddle)	50	Phosphate Buffer, pH 6.8	500	1, 3, 5, 7, 10, 15 and 20	08/15/2013
Fentanyl Citrate	Lozenges	II (Paddle)	175	0.1 M Phosphate Buffer, pH 4.5	500	5, 10, 20, 30 and 40	05/20/2009
Fentanyl Citrate (0.1 mg and 0.4 mg)	Tablet (Buccal)	II (Paddle) small volume dissolution apparatus	100	Phosphate Buffered Saline solution, pH 7.0	100	3, 5, 7.5, 10, 15 and 20	11/20/2009
Fentanyl Citrate (0.2 mg, 0.3 mg, 0.6 mg and 0.8 mg)	Tablet (Buccal)	II (Paddle) small volume dissolution apparatus	100	Phosphate Buffered Saline solution, pH 7.0	200	3, 5, 7.5, 10, 15 and 20	11/20/2009
Fentanyl Citrate (0.2 mg, 0.4 mg, 0.6 mg and 0.8 mg)	Film (Buccal)	I (Basket) 100 mL dissolution vessel	100	25-mM Phosphate Buffer, pH 6.4	60	5, 10, 15, 20, 30 and 45	12/15/2009
Fentanyl Citrate (1.2 mg)	Film (Buccal)	I (Basket) 100 mL dissolution vessel	100	25-mM Phosphate Buffer, pH 6.4	100	5, 10, 15, 20, 30 and 45	12/15/2009
Ferric Citrate	Tablet	II (Paddle)	100	EDTA media ( 2.0 grams of EDTA Na2 2H2O to 1000 mL of purified water)	900	10, 20, 30, 45 and 60	08/27/2015
Ferric Maltol	Capsule	II (Paddle with sinker)	75	Tier 1: KCl/HCl Buffer, pH 1.2; Tier 2: KCl/HCl Buffer pH 1.2, with pepsin	1000	5, 10, 20, 30 and 45	01/30/2020
Ferrous Fumarate	Tablet			Refer to USP			03/17/2016
Fesoterodine Fumarate	Tablet (Extended Release)	II (Paddle) with sinker	75	Phosphate Buffer, pH 6.8	900	1, 2, 4, 6, 8, 10, 12, 16 and 20 hours	08/15/2013
Fexinidazole	Tablet	II (Paddle)	75	0.1 N HCl with 3% w/v SLS	2000	10, 20, 30, 40, 50 and 60	05/18/2023
Fexofenadine HCl	Tablet	II (Paddle)	50	0.001 N HCl	900	5, 10, 20, 30 and 45	02/19/2004
Fexofenadine HCl	Capsule			Develop a dissolution method			09/15/2023
Fexofenadine HCl	Tablet (Orally Disintegrating)	II (Paddle)	50	0.001 N HCl	500	5, 10, 15, 30 and 45	09/03/2008
Fexofenadine HCl	Suspension	II (Paddle)	50	0.001 N HCl	900	10, 20, 30 and 45	11/25/2008
Fexofenadine HCl/Pseudoephedrine HCl	Tablet (Extended Release)			Refer to USP			04/02/2009
Fezolinetant	Tablet			Refer to FDA's Dissolution Guidance, 2018			08/05/2024
Fidaxomicin	Tablet			Develop a dissolution method			09/15/2023
Fidaxomicin	For Oral Suspension			Develop a dissolution method			09/15/2023
Finafloxacin	Otic Suspension			Develop a method to characterize in vitro release			03/17/2016
Finasteride	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Finasteride; Tadalafil	Capsule			Develop a dissolution method			02/05/2024
Finerenone	Tablet	II (Paddle)	75	Acetate Buffer, pH 4.5 (for 10 mg strength) and Acetate Buffer, pH 4.5 with 0.1% polysorbate 20 (for 20 mg strength)	900	5, 10, 15, 20 and 30	02/09/2023
Fingolimod	Capsule	I (Basket)	100	0.1 N HCl with 0.2% SDS (sodium dodecyl sulfate)	500	5, 10, 15, 20 and 30	08/15/2013
Fingolimod Lauryl Sulfate	Tablet, Orally Disintegrating	II (Paddle) with sinker	50	0.1 N HCl with 0.2% sodium dodecyl sulfate (SDS)	500	5, 10, 15, 20, 25, 30 and 45	11/30/2023
Flavoxate HCl	Tablet	I (Basket)	100	0.1 N HCl	900	5, 10, 20 and 30	01/29/2004
Flecainide Acetate	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Flibanserin	Tablet	II (Paddle)	50	Mcilvaine Buffer (Citric Acid/Phosphate Buffer), pH 4.0	900	5, 10, 15, 20 and 30	06/30/2016
Fluconazole	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Fluconazole (200 mg/5 mL)	Suspension			Develop a dissolution method			09/15/2023
Fluconazole (50 mg/5 mL)	Suspension			Develop a dissolution method			09/15/2023
Flucytosine	Capsule			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Fludarabine Phosphate	Tablet			Develop a dissolution method			09/15/2023
Fludrocortisone Acetate	Tablet			Refer to USP			05/20/2009
Fluoxetine	Capsules (Delayed Release)			Refer to USP			07/25/2007
Fluoxetine HCl	Capsule			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Fluoxetine HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Fluoxetine/Olanzapine	Capsule	II (Paddle)	50	0.1 N HCl	900	10, 20, 30 and 45	08/17/2006
Fluphenazine HCl	Tablet			Refer to USP			11/02/2017
Flutamide	Capsule			Develop a dissolution method			01/03/2024
Fluvastatin Sodium	Tablet (Extended Release)			Develop a dissolution method			09/15/2023
Fluvastatin Sodium	Capsule			Develop a dissolution method			01/03/2024
Fluvoxamine Maleate	Capsule (Extended Release)	II (Paddle)	50	Phosphate Buffer, pH 6.8	900	1, 2, 4, 6, 8 and 12 hours	01/15/2010
Fluvoxamine Maleate	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Fosamprenavir Calcium	Tablet	II (Paddle)	75	250 mM Sodium Acetate/Acetic acid buffer pH 3.5	900	10, 20, 30 and 45	12/16/2005
Fosamprenavir Calcium	Oral Suspension	II (Paddle)	25	10 mM HCl	900	5, 10,15 and 20	12/03/2007
Fosfomycin Tromethamine	For Suspension			Develop a dissolution method			07/20/2017
Fosinopril Sodium	Tablet			Develop a dissolution method			09/15/2023
Fosinopril Sodium/Hydrochlorothiazide	Tablet			Refer to USP			08/11/2008
Fostemsavir Tromethamine	Tablet (Extended Release	I (Basket)	100	0.05 M Phosphate Buffer, pH 6.8 buffer, pH 6.8	1000	1, 2, 3, 5, 7, 10, 12, 16, 20 and 24 hours	08/19/2021
Frovatriptan succinate	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Furosemide	Tablet			Refer to USP			08/05/2010
Futibatinib	Tablet	II (Paddle)	50	50 mM phosphate dihydrogen phosphate buffer, pH 6.8 with 0.5% Tween 80	900	5, 10, 15, 30, 45, 60 and 75	11/30/2023
Gabapentin	Tablet	I (Basket)	100	Modified simulated gastric fluid (SGF)	900	1, 2, 4, 6, 8, 10, 12, 14 and 16 hours	11/30/2023
Gabapentin	Capsule			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Gabapentin	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Gabapentin Enacarbil	Tablet (Extended Release)	II (Paddle)	50	10 mM Phosphate buffer at pH 7.4 with 1.0 % SLS	500 (for 300 mg); 900 (for 600 mg)	0.5, 1, 2, 4, 6, 8, 12 and 24 hours	01/31/2013
Galantamine HBr	Capsule (Extended Release)	II (Paddle)	50	50 mM potassium dihydrogen phosphate buffer pH 6.5	900	1, 4, 10 and 12 hours	01/20/2006
Galantamine HBr	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Ganaxolone	Suspension	II (Paddle)	25	2.8% SDS	900	2.5, 5, 7.5, 10, 15, 20 and 30	11/30/2023
Ganciclovir	Capsule			Develop a dissolution method			09/15/2023
Gefitinib	Tablet			Develop a dissolution method			09/15/2023
Gemfibrozil	Tablet			Refer to USP			07/25/2007
Gemifloxacin Mesylate	Tablet	II (Paddle)	50	0.01 N HCl	900	10, 20, 30 and 45	01/03/2007
Gilteritinib Fumarate	Tablet	II (Paddle)	50	0.1 N HCl	900	10, 15, 20, 30 and 45	08/27/2020
Glimepiride	Tablet	II (Paddle)	75	Phosphate Buffer, pH 7.8	900	5, 10, 15 and 30	07/23/2004
Glimepiride/Pioglitazone HCl	Tablet	II (Paddle)	75	For Pioglitazone: pH 2.0, HCl Buffer. For Glimepiride: pH 6.8, Sodium Phosphate Buffer with 0.2% sodium dodecyl sulfate	900	For Pioglitazone: 10, 15, 20, 30 and 45; For Glimepiride: 10, 15, 20 and 30	04/02/2009
Glimepiride/Rosiglitazone Maleate	Tablet	II (Paddle)	75	0.01 M HCl with 0.5% Sodium Dodecyl Sulfate	900	5, 10, 15, 30, 45 and 60	01/03/2007
Glipizide	Tablet (Extended Release)	II (Paddle)	50	Simulated Intestinal Fluid without pancreatin, pH 7.5	900	1, 2, 4, 8, 16 hours and until at least 80% dissolved	04/10/2008
Glipizide	Tablet			Refer to USP			08/05/2010
Glipizide/Metformin HCL	Tablet			Refer to USP			12/18/2008
Glyburide (Micronized)	Tablet	II (Paddle)	50	0.05 M Phosphate Buffer, pH 7.5	900	10, 20, 30, 45 and 60	02/02/2004
Glyburide (Non-micronized)	Tablet	II (Paddle)	75	0.05 M Borate Buffer, pH 9.5	500	10, 20, 30, 45 and 60	02/02/2004
Glyburide/Metformin HCl	Tablet			Refer to USP			01/14/2008
Glycopyrrolate	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Goserelin Acetate	Implant	Prior to sampling, the jar is removed from incubation and mechanically swirled with digital orbital shaker	Swirl orbit of 50 mm at 205 rpm for 6 seconds	Each implant should be incubated in 50 mL of phosphate buffered saline, pH 7.4, at 39°C (warmed overnight before the implants are added), in a 120-mL Wheaton jar.	50	3, 14, 35, 56 and 84 days (10.8 mg strength); 7, 14, 17, 21 and 28 days (3.6 mg strength)	11/04/2008
Granisetron	Film, Transdermal (Extended Release)	VI (Cylinder)	50	80 microL /L phosphoric acid (85%) at 32 ± 0.5°C	1000	2, 6, 12, 24, 36, 48, 60, 72 and 96 hours	03/03/2011
Granisetron	Injectable (Extended Release)			Develop a method to characterize in vitro release			12/22/2016
Granisetron HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Griseofulvin	Oral Suspension			Develop a dissolution method			09/15/2023
Griseofulvin (Microcrystalline)	Oral Suspension			Develop a dissolution method			09/15/2023
Griseofulvin (Microcrystalline)	Tablet			Develop a dissolution method			01/03/2024
Griseofulvin (Ultramicrocrystalline)	Tablet			Develop a dissolution method			01/03/2024
Guaifenesin	Tablet (Extended Release)	I (Basket)	75	0.1 N HCl	900	1, 2, 4, 6 and 12 hours	01/03/2007
Guaifenesin/Pseudoephedrine Hydrochloride	Tablet (Extended Release)	I (Basket)	50	0.01 N HCl	900	1, 2, 6, and 12 hours	11/25/2008
Guanfacine	Tablet (Extended Release)	II (Paddle)	75	HCl Buffer, pH 2.2	900	1, 2, 4, 6, 8, 10, 12, 16, 20 and 24 hours	07/01/2010
Guanfacine HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018	500		08/19/2021
Haloperidol	Tablet			Refer to USP			11/25/2008
Homatropine Methylbromide/Hydrocodone Bitartrate	Tablet			Develop a dissolution method			01/03/2024
Hydralazine HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Hydrochlorothiazide	Capsule			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Hydrochlorothiazide	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Hydrochlorothiazide/Irbesartan	Tablet	II (Paddle)	50	0.1 N HCl	1000	10, 20, 30 and 45	09/24/2008
Hydrochlorothiazide/Lisinopril	Tablet	II (Paddle)	50	0.1 N HCl	900	10, 20, 30, 45 and 60	02/03/2004
Hydrochlorothiazide/Losartan Potassium	Tablet			Develop a dissolution method			09/15/2023
Hydrochlorothiazide/Metoprolol Succinate	Tablet (Extended Release)	II (Paddle)	Hydrochlorothiazide: 100; Metoprolol succinate: 75	Hydrochlorothiazide: 0.1N HCl; Metoprolol succinate: Phosphate Buffer, pH 6.8	Hydrochlorothiazide: 500; Metoprolol succinate: 500	Hydrochlorothiazide: 10, 15, 20, 30, and 45 minutes; Metoprolol succinate: 1, 2, 4, 6, 8, 12, 16, 20 and 24 hours	10/31/2013
Hydrochlorothiazide/Metoprolol Tartrate	Tablet			Refer to USP			01/05/2012
Hydrochlorothiazide/Moexipril HCl	Tablet	II (Paddle)	50	0.1 N HCl	900	5, 10, 15 and 30	02/10/2004
Hydrochlorothiazide/Olmesartan Medoxomil	Tablet	II (Paddle)	50	0.05 M Phosphate Buffer, pH 6.8	900	5, 10, 15, 20, 30, 45 and 60	07/09/2007
Hydrochlorothiazide/Quinapril HCl	Tablet			Develop a dissolution method			09/15/2023
Hydrochlorothiazide/Spironolactone	Tablet			Refer to USP			08/27/2009
Hydrochlorothiazide/Telmisartan	Tablet			Refer to USP			06/30/2016
Hydrochlorothiazide/Triamterene	Tablet			Refer to USP			07/31/2013
Hydrochlorothiazide/Valsartan	Tablet			Refer to USP			07/28/2016
Hydrochlorothizide/Triamterene	Capsule			Refer to USP			10/06/2008
Hydrocodone Bitartrate	Capsule (Extended Release)	I (Basket)	100	0.05 M Phosphate Buffer, pH 6.8	500	1, 2, 4, 6, 8, 10 and 12 hours	05/28/2015
Hydrocodone Bitartrate	Tablet (Extended Release)	I (Basket-10 mesh)	100	Simulated gastric fluid (SGF) without enzyme (pH 1.2)	900	1, 2, 4, 8, 12, 16, 20 and 24 hours	04/14/2016
Hydrocodone Bitartrate/Ibuprofen	Tablet	II (Paddle)	50	Phosphate Buffer, pH 7.2	900	5, 10, 15 and 30	02/04/2004
Hydrocortisone	Tablet			Develop a dissolution method			01/03/2024
Hydromorphone HCl	Tablet (Extended Release)			Develop a dissolution method			09/15/2023
Hydromorphone HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Hydroxychloroquine Sulfate	Tablet			Refer to FDA's Dissolution Guidance, 2018			04/16/2020
Hydroxyurea	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/07/2022
Hydroxyurea	Capsule			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Hydroxyzine HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Hydroxyzine Pamoate	Capsule			Refer to USP			04/02/2009
Hydroxyzine Pamoate	Suspension			Develop a dissolution method			04/02/2009
Ibandronate Sodium	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Ibrexafungerp Citrate	Tablet	II (Paddle)	50	0.1N HCl	900	10, 15, 20, 30 and 45	02/09/2023
Ibrutinib	Capsule	II (Paddle)	75	3.0% w/v Polysorbate 20 in 50 mM Phosphate Buffer, pH 6.8	900	5, 10, 20, 30 and 45	06/25/2015
Ibrutinib (140 and 280 mg)	Tablet	II (Paddle)	75	3.0% w/v Polysorbate 20 in 50 mM Phosphate Buffer, pH 6.8	900	10, 20, 30, 45 and 60	04/02/2020
Ibrutinib (420 and 560 mg)	Tablet	II (Paddle)	75	6.0% w/v Polysorbate 20 in 50 mM Phosphate Buffer, pH 6.8	900	10, 20, 30, 45 and 60	04/02/2020
Ibuprofen	Capsule (Soft-Gelatin/Liquid Fill)	I (Basket)	150	50mM Phosphate Buffer, pH 7.2	900	5, 10, 20, 30 and 45	05/09/2013
Ibuprofen	Tablet (Chewable)	II (Paddle)	50	0.05 M Phosphate Buffer, pH 7.2	900	10, 20, 30 and 45	02/04/2004
Ibuprofen	Suspension			Refer to USP			11/04/2008
Ibuprofen	Suspension/Drop	II (Paddle)	50	Phosphate Buffer, pH 7.2	900	5, 10, 15 and 20	11/04/2008
Ibuprofen	Tablet			Refer to USP			07/25/2007
Ibuprofen Potassium	Capsule (Soft-Gelatin/Liquid Fill)	I (Basket)	150	Phosphate Buffer, pH 7.2	900	5, 10, 20 and 30	02/04/2004
Ibuprofen Sodium	Capsule	I (Basket)	150	Phosphate Buffer, pH 7.2	900	5, 10, 15, 20 and 30	06/25/2015
Ibuprofen/Diphenhydramine	Capsule	I (Basket)	100	Phosphate Buffer (200 mM), pH7.2	900	10, 20, 30 and 45	01/03/2007
Ibuprofen/Oxycodone HCl	Tablet	I (Basket)	100	Phosphate buffer, pH 7.2	500	10, 20, 30 and 45	04/09/2007
Ibuprofen/Phenylephrine HCl	Tablet	II (Paddle)	50	50 mM Potassium Phosphate Buffer, pH 6.5, (degassed)	900	10, 15, 20, 30 and 45	01/05/2012
Ibuprofen/Pseudoephedrine HCl	Capsule	I (Basket)	150	Tier 1: 0.05 M phosphate buffer, pH 7.2 Tier 2: 0.05 M phosphate buffer, pH 7.2 with NMT 1750 USP protease units/L of 1 X USP pancreatin	900	10, 20, 30 and 45	03/04/2006
Ibuprofen/Pseudoephedrine HCl	Suspension	II (Paddle)	50	0.05 M Phosphate Buffer, pH 7.2	900	5, 10, 15 and 30	02/04/2004
Icosapent Ethyl	Capsule			Develop an in vitro release method using USP IV (Flow-Through Cell), and, if applicable, Apparatus II (Paddle) or any other appropriate pharmacopoeial apparatus, for comparative evaluation by the Agency.			08/15/2013
Idelalisib	Tablet	II (Paddle)	75	0.01 N HCl	750	5, 10, 15, 20 and 30	08/27/2015
Iloperidone	Tablet	II (Paddle)	50	0.1 N HCl	500	5, 10, 15, 30, 45 and 60	08/05/2010
Imatinib Mesylate	Tablet	II (Paddle)	50	0.1 N HCl	1000	5, 10, 15, 20 and 30	09/22/2011
Imipramine HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Imipramine Pamoate	Capsule	I (Basket)	100	0.1 N HCl without pepsin and with 0.3% pepsin (addition of pepsin is recommended only when significant slow dissolution is observed)	900	30, 60, 90, 120, 150 and 180	01/14/2008
Indapamide	Tablet			Refer to USP			04/15/2008
Indinavir Sulfate	Capsule	II (Paddle)	50	0.1 M Citrate Buffer, pH 3.8	900	10, 15, 20 and 30	02/04/2004
Indomethacin	Rectal Suppository			Refer to USP			08/26/2021
Indomethacin	Suspension			Refer to USP			05/31/2024
Indomethacin	Capsule (Extended Release)			Refer to USP			07/25/2007
Indomethacin (40 mg and 20 mg)	Capsule	I (Basket)	100	10 mM citric acid buffer, pH 5.75	750	5, 10, 15, 20 and 30	05/28/2015
Indomethacin (50 and 25 mg)	Capsule			Refer to USP			05/28/2015
Infigratinib Phosphate	Capsule	I (Basket)	100	0.01 N HCl	900	15, 30, 45 and 60	05/18/2023
Irbesartan	Tablet			Refer to USP			08/11/2008
Isavuconazonium Sulfate	Capsule	II (Paddle) with sinker	75	Diluted McIlvaine Buffer [12.5 mM disodium hydrogen phosphate solution +6.25 mM citric acid solution ] + 0.5 % Sodium Lauryl sulfate (SLS)	900	10, 20, 30, 45, 60, 75 and 90	03/17/2016
Isocarboxazid	Tablet	II (Paddle)	50	0.1 N HCl	900	10, 20, 30, 45 and 60	02/04/2004
Isoniazid	Tablet			Refer to USP			04/15/2008
Isosorbide Dinitrate	Capsule (Extended Release)			Refer to USP			06/25/2015
Isosorbide Dinitrate	Tablet (Extended Release)			Develop a dissolution method			01/03/2024
Isosorbide Dinitrate	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Isosorbide Dinitrate/Hydralazine HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018			08/19/2021
Isosorbide Mononitrate	Tablet			Develop a dissolution method			09/15/2023
Isosorbide Mononitrate	Tablet (Extended Release)			Develop a dissolution method			01/03/2024
Isotretinoin	Capsule			Refer to USP			04/22/2021
Isradipine	Capsule			Develop a dissolution method			09/15/2023
Isradipine	Tablet (Extended Release)			Develop a dissolution method			09/15/2023
Istradefylline	Tablet			Develop a dissolution method			09/15/2023
Itraconazole	Capsule	II (Paddle)	100	SGF without Enzyme	900	10, 20, 30, 45, 60 and 90	02/04/2004
Itraconazole	Tablet	II (Paddle)	75	0.1 N HCl	900	5, 15, 30, 45, 60, 75 and 90	08/15/2013
Ivabradine HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Ivacaftor	Tablet	II (Paddle) with sinker	65	50 mM Sodium Phosphate Buffer with 0.7% Sodium Dodecyl Sulfate (SDS), pH 6.8	900	5, 10, 15, 20 and 30	06/25/2015
Ivacaftor/lumacaftor	Tablet	Lumacaftor: II (Paddle); Ivacaftor: II (Paddle)	Lumacaftor:65; Ivacaftor: 65	Lumacaftor: 0.5% (w/v) CTAB in 50 mM Sodium Acetate Trihydrate buffer (pH 4.5); Ivacaftor: 0.4% (w/v) SLS in 50 mM Sodium Phosphate buffer (pH 6.8)	Lumacaftor: 900; Ivacaftor: 900	5, 10, 15, 20 and 30	03/17/2016
Ivacaftor/Tezacaftor [FDC: IVA+ TEZ]; Ivacaftor [IVA]	Tablet/Tablet (Copackage)	II (Paddle) with option to use a sinker	FDC: IVA: 65/TEZ:75; IVA: 65	FDC: IVA: 50 mM Sodium Phosphate Buffer with 0.4% Sodium Dodecyl Sulfate (SDS), pH 6.8/TEZ: 0.2 SDS% in 0.1 N HCl; IVA: 50 mM Sodium Phosphate Buffer with 0.7% SDS, pH 6.8;	FDC: IVA: 900/ TEZ: 900; IVA: 900	5, 10, 15, 20, 30 and 45	03/07/2019
Ivermectin	Tablet	II (Paddle)	50	0.5% SDS in 0.01 M Monobasic Sodium Phosphate, pH 7.0	900	10, 20, 30, 45 and 60	02/04/2004
Ivosidenib	Tablet	II (Paddle)	50	50 mM Phosphate Buffer pH, 6.8 with 0.6% sodium dodecyl sulfate (SDS),	900	10, 15, 20, 30 and 45	08/27/2020
Ixazomib Citrate	Capsule	I (Basket)	100	0.1 N HCl	500	5, 10, 15, 20 and 30	10/20/2016
Ketoconazole	Tablet	I (Basket)	100	Simulated gastric fluid w/o pepsin	800	15, 30, 45, 60 and 90	01/03/2007
Ketoprofen	Capsule	II (Paddle with sinker)	50	0.05M Potassium Phosphate Buffer, pH 7.4	1000	10, 20, and 30	02/09/2023
Ketoprofen	Tablet	II (Paddle)	50	SIF Buffer without enzyme, pH 7.4	900	10, 20, 30, 45 and 60	02/05/2004
Ketorolac Tromethamine	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Labetalol HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Lacosamide	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Lacosamide	Capsule (Extended Release)	I (Basket)	100	Phosphate Buffer, pH 6.8	900	0.5, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours	05/31/2024
Lamivudine	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Lamivudine 150 mg/Zidovudine 300mg Tablets and Abacavir Sulfate 300 mg Tablets-co-packaged	Tablet	II (Paddle)	75	0.1 N HCl	900	5, 10, 15, 20, 30 and 40	01/03/2007
Lamivudine/Raltegravir Ka	Tablet			Develop a dissolution method			09/15/2023
Lamivudine/Stavudine/Nevirapine	Tablet	II (Paddle)	75	0.1 N HCl	900	10, 20, 30, 45 and 60	01/03/2007
Lamivudine/Zidovudine	Tablet			Refer to USP			11/02/2017
Lamivudine/Zidovudine + Efavirenz	Tablet (Copackage)	II (Paddle)	Lamivudine and Zidovudine: 75	Lamivudine and Zidovudine: 0.1 N HCl Efavirenz: Develop a dissolution method	Lamivudine and Zidovudine: 1000	10, 20, 30, and 45	09/15/2023
Lamivudine/Zidovudine + Nevirapine	Tablet (Copackage)	II (Paddle)	50	Lamivudine and Zidovudine: Develop a dissolution method Nevirapine: 0.06 M HCl (pH 1.2)	900	10, 15, 30, 45 and 60	09/15/2023
Lamivudine/Zidovudine/ Nevirapine	Tablet	II (Paddle)	50	0.01 N HCl	900	10, 15, 30, 45 and 60	01/03/2007
Lamotrigine	Tablet (Chewable dispersible)	II (Paddle)	50	0.1 N HCl	900	5, 10, 15, 20 and 30	01/14/2008
Lamotrigine	Tablet, For Suspension			Refer to USP			02/09/2023
Lamotrigine	Tablet (Regular)	II (Paddle)	50	0.1 N HCl	900	5, 10, 15, 20 and 30	03/04/2006
Lamotrigine	Tablet (Extended Release)			Refer to USP			02/18/2016
Lansoprazole	Capsule (Delayed Release)			Refer to USP			11/04/2008
Lansoprazole	Tablet (Delayed Release, Orally Disintegrating)	II (Paddle)	75	Acid Stage: 0.1 N HCl; Buffer Stage: Phosphate Buffer, pH 6.8 with 5 mM Sodium Dodecyl Sulfate	500 (Acid), 900 (Buffer)	60 (Acid), 10, 20, 30 and 45 (Buffer)	11/04/2008
Lanthanum Carbonate	Chewable Tablet	Reciprocating Cylinder (Apparatus 3 modified)	10 dpm (dip rate per minute)	0.25 N HCl	900 (modified from the standard apparatus 3 vessel to achieve sink condition)	10, 20, 30 and 45	01/03/2007
Lapatinib Ditosylate	Tablet	II (Paddle)	55	2% Polysorbate 80 in 0.1 N HCl	900	10, 15, 30 and 45	10/30/2009
Lasmiditan Succinate	Tablet			Refer to FDA's Dissolution Guidance, 2018			05/12/2022
Ledipasvir/Sofosbuvir	Tablet	II (Paddle)	75	1.5% Polysorbate 80 in 10 mM Potassium Phosphate Buffer with 0.0075 mg/mL Butylated Hydroxytoluene (BHT), pH 6.0	900	5, 10, 15, 20, 30, 45 and 60	08/27/2015
Ledipasvir/Sofosbuvir	Pellets	II (Paddle)	75	1.0% polysorbate 80 in 25 mM Potassium Phosphate Buffer, with 0.005 mg/mL Butylated Hydroxytoluene (BHT), pH 5.5	900	5, 10, 15, 20, 30, 45 and 60	08/19/2021
Lefamulin Acetate	Tablet	II (Paddle)	50	0.1 N HCl	1000	10, 20, 30, 45, 60, 75, and 90	04/22/2021
Leflunomide	Tablet			Develop a dissolution method			09/15/2023
Leflunomide (100 mg)	Tablet			Develop a dissolution method			09/15/2023
Lemborexant	Tablet	II (Paddle)	50	0.1 N HCl	900	5, 10, 15, 20 and 30	05/12/2022
Lenacapavir Sodium	Tablet	II (Paddle) with sinkers	75	30 mM potassium phosphate, pH 6.0 with 2.0% Cremophor EL	900	10, 15, 20, 25, 30, 45 and 60	02/05/2024
Lenalidomide	Capsule	II (Paddle)	50	0.01 N HCl	900	10, 15, 20, 30 and 45	04/15/2008
Leniolisib Phosphate	Tablet	I (Basket)	100	Acetate Buffer, pH 4.0	900	10, 20, 30, 40, 50, 60, 70 and 80	08/05/2024
Lenvatinib Mesylate	Capsule	II (Paddle)	50	0.1 N HCl	900	5, 10, 15, 20 and 30	03/17/2016
Lesinurad	Tablet	II (Paddle)	75	pH 4.5 sodium acetate buffer with 1% SLS	900	10, 20, 30 and 45	03/17/2016
Letermovir	Tablet	II (Paddle)	75	25 mM Na Acetate Buffer, pH 4.5 with 0.6% Tween-80	900	10, 15, 20, 30, 45 and 60	02/08/2018
Letrozole	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Letrozole (LET); Ribociclib Succinate (RIB)	Tablet/Tablet (Copackage)	II (Paddle)	RIB: 50; LET: 75	RIB: 0.01 N HCl; LET: 0.1 N HCl	RIB: 900; LET: 900	5, 10, 15, 20, 30 and 45	03/07/2019
Leucovorin Calcium	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Leuprolide Acetate	Injectable (Extended Release)			Develop a dissolution method using USP IV (Flow-Through Cell), and, if applicable, Apparatus II (Paddle) or any other appropriate method, for comparative evaluation by the Agency			01/15/2010
Leuprolide Acetate	Implant			Develop a method to characterize in vitro releas			05/12/2022
Leuprolide Mesylate	Emulsion			Develop a method to characterize in vitro release			10/06/2023
Levetiracetam	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Levetiracetam	Tablet, for Suspension	II (Paddle)	50	Phosphate Buffer, pH 6.8 (degas)	900	2.5, 5, 10, 15 and 20	03/02/2017
Levetiracetam	Tablet (Extended Release)	I (Basket)	100	0.05 M Phosphate Buffer, pH 6.0	900	1, 2, 4, 6, 8 and 12 hours	04/02/2009
Levocarnitine	Tablet			Develop a dissolution method			01/03/2024
Levocetirizine Dihydrochloride	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Levofloxacin	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Levomilnacipran HCl	Capsule (Extended Release)			Develop a dissolution method			09/15/2023
Levonorgestrel	Intrauterine Device			Develop a method to characterize in vitro release			02/14/2014
Levonorgestrel	Tablet	II (Paddle)	75	0.1 N HCl with 0.1% SLS	1000	10, 20, 30, 45, 60 and 90	02/05/2004
Levorphanol Tartrate	Tablet			Refer to FDA's Dissolution Guidance, 2018			04/22/2021
Levothyroxine Sodium	Tablet			Refer to USP			07/25/2007
Lidocaine	Topical Patch	Paddle over Disk (Apparatus 5)	50	Acetic acid/sodium acetate buffer, pH 4.0 at 32ºC	500	10, 20, 30, 60, 120 and 180	01/03/2007
Linaclotide	Capsule	I (Basket)	50	50 mM Phosphate Buffer, pH 4.5	500	5, 10, 15, 20 and 30	12/24/2015
Linagliptin	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Linagliptin/Metformin HCl	Tablet (Extended Release)	I (Basket)	100	Simulated Gastric Fluid (SGF) without enzyme (pH 1.2) (degassed)	900	Linagliptin 10, 15, 20, 30 and 45 minutes; Metformin: 1, 2, 4, 6, 8 and 12 hours	07/28/2016
Linagliptin/Metformin HCl	Tablet	II (Paddle)	50	0.1 N HCl	900	5, 10, 15, 20, 30 and 45	05/15/2014
Linezolid	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Linezolid	Suspension	II (Paddle)	50	0.05 M Phosphate Buffer, pH 6.8	900	10, 20, 30 and 45	01/14/2008
Liothyronine Sodium	Tablet			Refer to USP			06/18/2007
Lisdexamfetamine Dimesylate	Capsule			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Lisinopril	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Lithium Carbonate	Capsule			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Lithium Carbonate	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Lithium Carbonate	Tablet (Extended Release)			Refer to USP			01/14/2008
Lomefloxacin HCl	Tablet	II (Paddle)	50	0.01 N HCl	900	10, 20, 30 and 45	02/05/2004
Lomitapide Mesylate	Capsule	II (Paddle)	50	0.001 N HCl with 0.1% Polysorbate 80	500 mL (5 mg strength); 1000 mL (10 and 20 mg strength)	5, 10, 20, 30 and 45	06/25/2015
Lomustine	Capsule			Develop a dissolution method			12/24/2015
Lonafarnib	Capsule			Develop a dissolution method			09/15/2023
Loperamide HCl	Oral Suspension	II (Paddle)	25	0.01 N HCl	900	10, 20, 30, 45, 60, 75 and 90	06/25/2015
Loperamide HCl	Tablet (Chewable)	II (Paddle)	50	0.2 M Acetate Buffer, pH 4.7	500	5, 10, 15, 20 and 30	06/25/2015
Loperamide HCl	Capsule			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Loperamide HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Loperamide HCl/Simethicone	Tablet (Chewable)	II (Paddle)	50	0.2 M Acetate Buffer, pH 4.7	500	5, 10, 15, 20 and 30	02/09/2023
Loperamide HCl/Simethicone	Tablet	II (Paddle)	75	0.1N HCl	500	10, 15, 20, 30 and 45	08/27/2015
Lopinavir/Ritonavir	Tablet (Combination)			Refer to USP			01/15/2015
Lopinavir/Ritonavir	Capsule (Soft-Gelatin)	II (Paddle)	50	Tier 1: 0.05 M Polyoxyethylene 10 Lauryl Ether with 10 mM Sodium Phosphate monobasic (pH 6.8); Tier II: same as above with NMT 1750 USP units/L of Pancreatin	900	10, 15, 30 and 45	06/18/2007
Loratadine	Tablet (Orally Disintegrating)	I (Basket)	50	SGF without enzyme	900	2, 4, 6 and 10	07/14/2008
Loratadine	Tablet (Chewable)	II (paddle)	50	0.1 N HCl	500	15, 30, 45 and 60	07/14/2008
Loratadine	Capsule (Soft-Gelatin)	II (Paddle) with sinker	75	Tier I: 0.1N HCl with 0.1% Tween 20. Tier II: 0.1N HCl with 0.1% Tween 20 with addition of pepsin (as per USP).	900	10, 20, 30, 45 and 60	02/28/2013
Loratadine/Pseudoephedrine Sulfate (10 mg /240 mg)	Tablet (Extended Release)	I (Basket)	75	900 mL 0.1 N HCl for one hour, then replace the medium with 900 mL 0.05 M phosphate buffer at pH6.8 containing 0.01% sodium lauryl sulfate.	900	Loratadine:10, 15, 20, 30 and 45; Pseudoephedrine: 1, 2, 4, 8, 12, 16, 18 and 24 hours	08/05/2010
Loratadine/Pseudoephedrine Sulfate (5 mg /120 mg)	Tablet (Extended Release)	II (Paddle)	50	900 mL 0.1 N HCl for one hour, then replace with 900 mL 0.05 M phosphate buffer at pH 8.2 containing 0.01% sodium lauryl sulfate	900	Loratadine:15, 20, 30, 45, 60 and 90; Pseudoephedrine: 1, 2, 4, 8, 12 and 16 hours	08/05/2010
Lorazepam	Capsule (Extended Release)	I (Basket)	100	Acid Stage: 0.1N HCl; Buffer stage: Sodium Phosphate Buffer, pH 7.4	Acid stage: 700; Buffer stage: 1000	Acid stage: 0.5, 1 and 2 hours; Buffer stage: 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours	05/12/2022
Lorazepam	Tablet			Develop a dissolution method			01/03/2024
Lorcaserin HCl	Tablet (Extended Release)	I (Basket)	100	0.1 N HCl (deaerated)	900	1, 2, 4, 5, 8 12, 16 and 20 hours	10/20/2016
Lorcaserin HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Losartan Potassium	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Loteprednol Etabonate	Ophthalmic Suspension			Develop a method to characterize in vitro release			06/30/2016
Loteprednol Etabonate/Tobramycin	Ophthalmic Suspension			Develop a method to characterize in vitro release			01/31/2013
Lovastatin	Tablet (Extended Release)	II (Paddle)	50	0.5% sodium lauryl sulfate (SLS) / sodium phosphate buffer (0.01M), pH 6.5	900	1, 2, 4, 6, 8, 12, 16 and 20 hours	02/07/2019
Lovastatin/Niacin	Tablet (Extended Release)	I (Basket)	100	For Niacin: Develop a dissolution method; for Lovastatin: 0.05 M phosphate buffer, pH 7.0 with 0.5% sodium dodecyl sulfate	900	For Lovastatin: 15, 30, 45 and 60 min	09/15/2023
Lubiprostone	Capsule (Soft-Gelatin)	II (Paddle)	50	0.1 N HCl/1% HCO-40 (Polyoxyl 40 hydrogenated castor oil)	900	15, 30, 45, 60, 90 and 120	08/19/2010
Lurasidone HCl	Tablet	II (Paddle)	50	McIlvaine buffer, pH 3.8 [(0.025 M Citric acid Solution + 0.05M Na2HPO4 solution (3:2)] Measure the pH and adjust to 3.8, if necessary. Degas before use.	900	5, 10, 15, 20 and 30	01/31/2013
Macitentan	Tablet	II (Paddle)	75	Phosphate Buffer, pH 6.8 with 0.1% of Cetrimonium bromide (CTAB)	900	10, 15, 20, 30 and 45	05/28/2015
Macitentan (MAC); Tadalafil (TAD)	Tablet	II (Paddle)	60	MAC: 0.05 M sodium phosphate buffer, pH 5.5 with 0.30% (w/v) CTAB; (TAD):0.05 M sodium phosphate buffer, pH 6.8 with 3.0% (w/v) polysorbate 20	900	5, 10, 15, 20, 30, 45 and 60	08/05/2024
Magnesium Hydroxide/Omeprazole/Sodium Bicarbonate	Tablet (Chewable)	II (Paddle)	150	0.029 M sodium phosphate buffer w/ 0.5% SDS, pH 7.4	900	15, 30, 45, and 60	02/19/2008
Magnesium Hydroxide/Omeprazole/Sodium Bicarbonate	Tablet (Chewable)	II (Paddle)	150	pH 7.4 Phosphate Buffer with 0.5% SDS	900	15, 30, 45, 60 and 90	10/06/2008
Magnesium Sulfate/Potassium Chloride/Sodium Sulfate	Tablet			Develop a dissolution method			09/15/2023
Maraviroc	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Maribavir	Tablet	II (Paddle)	50	0.1N HCl (deaerated)	900	10, 15, 20, 30 and 45	02/09/2023
Maribavir	Tablet	II (Paddle)	50	0.1 N HCl	900	5, 10, 15, 20 and 45	07/07/2023
Mavacamten	Capsule	II (Paddle)	50	Tier 1: 0.05%(w/v) SDS in 50 mM Sodium Phosphate, pH 6.8; Tier 2: 50 mM sodium phosphate, pH 6.8, containing NMT 2,000 unit/L of pancreatin (850 mL). After 10 minutes, add 50 mL of 50 mM sodium phosphate, pH 6.8, containing 0.9% (w/v) SDS	900	10, 15, 30, 45 and 60	05/18/2023
Mebendazole	Tablet (Chewable)	II (Paddle)	75	0.1 N HCl containing 1% Sodium Lauryl Sulfate	900	15, 30, 45, 60, 90 and 120	10/06/2008
Mebendazole ( 500 mg)	Tablet (Chewable)	II (Paddle)	75	1% Sodium Lauryl Sulfate (SLS) in 0.01 N HCl	900	5, 10, 15, 30, 45 and 60	12/22/2016
Mecamylamine HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Meclizine HCl	Tablet (Chewable)	I (Basket)	100	0.01 N HCl	900	10, 20, 30, 45 and 60	04/08/2010
Meclizine HCl	Tablet	I (Basket)	100	0.01 N HCl	900	10, 20, 30, 45 and 60	08/27/2009
Medroxyprogesterone Acetate	Tablet			Develop a dissolution method			01/03/2024
Medroxyprogesterone Acetate	Injectable Suspension			Develop a dissolution method			09/15/2023
Medroxyprogesterone Acetate (104mg/0.65ml)	Injectable Suspension			Develop a method to characterize in vitro release			02/08/2018
Mefenamic Acid	Capsule			Refer to USP			12/15/2009
Mefloquine HCl	Tablet	I (Basket)	100	SGF without enzyme	900	10, 20, 30, 45 and 60	02/06/2004
Megestrol Acetate	Oral Suspension			Develop a dissolution method			01/03/2024
Meloxicam	Capsule	I (Basket)	100	Phosphate Buffer, pH 6.1 with 0.1% Sodium Lauryl Sulfate (SLS)	500 mL (for 5 mg); 1000 mL (for 10 mg)	5, 10, 15, 20 and 30	06/30/2016
Meloxicam	Suspension	II (Paddle)	25	Phosphate buffer at pH 7.5	900	5, 10, 15 and 30	01/26/2006
Meloxicam	Tablet	II (Paddle)	75	Phosphate Buffer, pH 7.5	900	10, 20, 30, 45 and 60	02/20/2004
Melphalan	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Memantine HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Memantine HCl	Capsule (Extended Release)	I (Basket)	100	pH 1.2 NaCl/HCl Buffer (degas)	900	1, 2, 3, 4, 6, 8, 10 and 12 hours	03/02/2017
Menthol/Methyl Salicylate	Topical Patch	VI (Cylinder)	50	Neutralized phthalate buffered solution (0.2 M potassium biphthalate) with pH of 5.0 at 32 ± 0.5°C	900	10, 20, 30, 60, 120, 150 and 180	01/31/2013
Meprobamate	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Mercaptopurine	Oral Suspension	II (Paddle)	50	0.1N HCl	900	5, 10, 15, 20 and 30	12/24/2015
Mercaptopurine	Tablet	II (Paddle)	50	0.1 N HCl	900	20, 30, 45, 60, 90 and 120	02/06/2004
Mesalamine	Suppository	II (Paddle) with option to use a sinker	75 (for 500 mg) & 125 (for 1000 mg)	For 500 mg strength: 0.2 M Phosphate buffer, pH 7.5 at 37 deg. C For 1000 mg strength: 0.2 M Phosphate buffer, pH 7.5 at 40 deg. C	900	30, 60, 90, 120 and 150	01/30/2006
Mesalamine	Capsule (Delayed Release)	II (Paddle)	Phase 1 & 2: 100 rpm; Phase 3: 50 rpm	Phase 1: 0.1N HCl (degas); Phase 2: pH 6.0 Buffer (degas); Phase 3: pH 7.2 Buffer	Phase 1: 500; Phase 2: 900; Phase 3: 900	Phase 1: 120; Phase 2: 60; Phase 3: 20, 30, 45, 60, 75, 90 and 120	06/30/2016
Mesalamine (1.2 gram)	Tablet (Delayed Release)	II (Paddle)	100	Acid stage (A): 100 mM HCl Buffer stage (B): Phosphate Buffer, pH 6.4 Buffer stage (C): Phosphate Buffer, pH 7.2	Acid stage (A): 750 mL; Buffer stage (B): 950 mL; Buffer stage (C): 960 mL	Acid stage (A): 2 hours; Buffer stage (B): 1 hour; Buffer stage (C): 1, 2, 4, 6 and 8 hours	06/10/2009
Mesalamine (250 mg and 500 mg)	Capsule (Extended Release)			Refer to USP			06/10/2009
Mesalamine (375 mg)	Capsule (Extended Release)	I (Basket)	100	Acid Stage: 0.1N HCl Buffer stage: Phosphate Buffer, pH 6.8	Acid stage: 750 mL; Buffer stage: 1000 mL	Acid stage: 2 hours; Buffer stage: 0.5, 1, 2, 4, 7 and 9 hours	06/10/2009
Mesalamine (400 mg and 800 mg)	Tablet (Delayed Release)			Refer to USP			11/05/2010
Mesalamine Enema	Rectal Enema	II (Paddle)	50	Phosphate Buffer, pH 7.2	900	5, 10, 15, and 30	06/18/2007
Mesna	Tablet	II (Paddle)	50	0.06 N HCl	500	5, 10, 15, 20 and 30	02/09/2004
Mestranol/Norethindrone	Tablet			Refer to USP			03/25/2010
Metaxalone	Tablet			Develop a dissolution method			01/03/2024
Metformin HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Metformin HCl	Tablet (Extended Release)			Refer to USP			12/12/2008
Metformin HCl	For Suspension (Extended Release)	II (Paddle)	100	Phosphate Buffer, pH 6.8	1000	0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours	01/30/2020
Metformin HCl (MET); Sitagliptin (SIT)	Tablet (Extended Release)	II (Paddle) with sinker	75	Phosphate buffer, pH 6.8	900	MET: 1, 2, 3, 4, 6, 8, 10, and 12 hours; SIT: 10, 20, 30, 45 and 60	07/07/2023
Metformin HCl/Pioglitazone HCl	Tablet	II (Paddle)	50	pH 2.5 McIlvaine buffer (0.1 M Citric acid adjusted to pH 2.5 with 0.2 M Na2HPO4)	900	10, 20, 30 and 45	01/03/2007
Metformin HCl/Saxagliptin	Tablet (Extended Release)	I (Basket)	100	Phosphate Buffer, pH 6.8	1000	Metformin: 1, 2, 3, 4, 6, 8, 10 and 12 hours. Saxagliptin: 5, 10, 15, 20 and 30 minutes	01/26/2012
Metformin HCl/Sitagliptin Phosphate	Tablet	II (Paddle)	75	0.025 M NaCl	900	10, 15, 20 and 30	10/06/2008
Metformin/Repaglinide	Tablet	II (Paddle)	50	Citric acid/phosphate buffer, pH 5.0	900	5, 10, 15, 20 and 30	10/30/2009
Methadone HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Methazolamide	Tablet	II (Paddle)	100	pH 4.5 Acetate Buffer	900	10, 15, 20, 30 and 45	05/28/2015
Methenamine Hippurate	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Methimazole	Tablet			Refer to USP			01/14/2008
Methocarbamol	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Methotrexate Sodium	Tablet			Develop a dissolution method			01/03/2024
Methoxsalen	Capsule			Develop a dissolution method			01/03/2024
Methscopolamine Bromide	Tablet			Refer to USP			02/15/2018
Methylergonovine Maleate	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Methylnaltrexone Bromide	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Methylphenidate	Tablet (Extended Release, Orally Disintegrating )	II (Paddle)	75	Acid Stage: 0.1 N HCl; Buffer Stage: Phosphate Buffer, pH 6.8	Acid Stage: 900 mL; Buffer Stage: 1000 mL	Acid Stage: 15, 30, 60, 120 minutes; Buffer Stage: 1, 2, 3, 4, 6 and 8 hours	11/16/2017
Methylphenidate	Tablet (Extended Release)			Develop a dissolution method			01/03/2024
Methylphenidate	Capsule (Extended Release)			Develop a dissolution method			09/15/2023
Methylphenidate	Transdermal Patch	VI (Cylinder)	50	0.01 N HCl at 32ºC	900	0.5, 1.5, 3, 4 hours and until at least 80% released	04/15/2008
Methylphenidate (BX)	Capsule (Extended Release)	I (Basket)	75	0-2 hrs:0.01 N HCl. 2-10 hrs: Phosphate Buffer, pH 6.8.	0-2 hrs: 500. 2-10 hrs:500	0.5, 1, 3, 6, 8 and 10 hours	07/25/2007
Methylphenidate HCl	Capsule (Extended Release)	I (Basket)	100	Acid Stage:(First 2 hours) 0.01 N HCl; Buffer Stage (2-10 hours): Phosphate Buffer, pH 6.0	Acid: 500 mL; Buffer: 500 mL	0.5, 1, 2, 4, 6, and 10 hours	10/20/2016
Methylphenidate HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Methylphenidate HCl	Tablet (Extended Release, Chewable)	II (Paddle)	75	0.4M KH2PO4 solution (degas)	900	0.25, 0.5, 1, 2, 3, 4, 6, 8 hours	03/17/2016
Methylphenidate HCl	Powder for Suspension (Extended Release)	II (Paddle)	75	0.4 M Phosphate Buffer, pH 4.5	900	0.25, 0.5, 1, 2, 3, 4, 6 and 8 hours	06/02/2016
Methylphenidate HCl	Tablet (Chewable)			Develop a dissolution method			09/15/2023
Methylphenidate HCl (25 mg, 35 mg, 45 mg, 55 mg, 70 mg and 85 mg)	Capsule (Extended Release)	II (Paddle) with sinker	75	Acid Stage:(0-6 hours) Simulated Gastric Fluid [SGF, pH 1.2] without enzyme; Buffer Stage (after six hours in acid stage): Phosphate Buffer, pH 7.4		Acid Stage: 0.5, 1, 2, 4, 6 hours; Buffer Stage: 1, 2, 4, 6, 8 and 10 hours	04/02/2020
Methylprednisolone	Tablet			Develop a dissolution method			01/03/2024
Methylprednisolone Acetate	Injectable Suspension	IV (Flow-Through Cell-Open system)		0.55 % SDS		15, 30, 45, 60, 90 and 120	10/08/2009
Methyltestosterone	Capsule			Develop a dissolution method			01/03/2024
Methyltestosterone	Tablet			Develop a dissolution method			09/15/2023
Metoclopramide HCl	Tablet			Develop a dissolution method			01/03/2024
Metoclopramide HCl	Tablet (Orally Disintegrating)			Develop a dissolution method			09/15/2023
Metolazone	Tablet			Refer to USP			04/02/2020
Metoprolol Succinate	Tablet (Extended Release)			Refer to USP			07/25/2007
Metoprolol Tartrate	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Metronidazole	Capsule			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Metronidazole	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Metyrosine	Capsule			Refer to USP			02/15/2018
Mexiletine HCl	Capsule			Refer to FDA's Dissolution Guidance, 2018			04/22/2021
Miconazole	Tablet (Buccal)	I (Basket)	60	0.5% SDS (Sodium dodecylsulfate) in water-pH adjusted to 6.5 ± 0.5	1000	1, 2, 4, 6, 8, 10 and 12 hours	10/28/2010
Miconazole Nitrate	Suppository (Vaginal)	I (Basket)	100	0.45% SLS in water	900	15, 30, 45 and 60	10/08/2009
Midodrine HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Midostaurin	Capsule			Develop a dissolution method			09/15/2023
Mifepristone	Tablet	II (Paddle)	75	0.01 N HCl	900	5, 10, 15, 20 and 30	01/14/2008
Mifepristone [300 mg]	Tablet	II (Paddle)	50	pH 1.8 KCl Buffer	900	10, 15, 20, 30 and 45	03/17/2016
Miglitol	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Miglustat	Capsule	I (Basket)	100	0.1 N HCl	1000	10, 20, 30 and 45	01/03/2007
Milnacipran HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Miltefosine	Capsule			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Minocycline HCl	Capsule			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Minocycline HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Minocycline HCl	Capsule (Extended Release)	I (Basket- 10 mesh)	100	0.1 N HCl	900	0.25, 0.5, 1.0, 1.5, 2, 3 and 4 hours	06/02/2016
Minocycline HCl	Capsule			Develop a dissolution method			01/03/2024
Minocycline HCl	ER Tablets	I (Basket)	100	0.1 N HCl	900	1, 2, 4, 6 hours and until 80% of drug released	01/14/2008
Minocycline HCl (135 mg and 105 mg)	Tablet (Extended Release)	I (Basket)	100	pH 2.1 Buffer (Degassed)	900	15, 30, 45, 60, 90, 120, 180 and 210	11/02/2017
Minoxidil	Tablet			Refer to USP			04/15/2008
Mirabegron	Granules, for Oral Suspension (Extended Release)	II (Paddle)	100	Stage 1: USP Phosphate Buffer (0.036 mol), pH 6.8 (0-4 hours); Stage 2: Phosphate Buffer pH 6.8 (0.108 mol), (after 4 hours)	Stage 1: 500; Stage 2: 1000	0.25, 0.5, 1, 2, 4, 6, 8 and 10 hours	05/12/2022
Mirabegron	Tablet (Extended Release)	I (Basket)	100	Phosphate Buffer, pH 6.8	900	1, 3, 5, 7, 8.5, 10 and 12 hours	05/09/2013
Mirtazapine	Tablet (Orally Disintegrating (ODT))	II (Paddle)	50	0.1 N HCl	900	5, 10, 15, 20 and 30	03/04/2006
Mirtazapine	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Misoprostol	Tablet			Develop a dissolution method			09/15/2023
Mitapivat Sulfate	Tablet	II (Paddle)	70	100 mM sodium phosphate, pH 6.8, with 0.05% w/w sodium dodecyl sulfate (SLS)	900	5, 10, 15, 20 and 30	03/30/2023
Mitotane	Tablet			Develop a dissolution method			01/03/2024
Mobocertibib Succinate	Capsule	II (Paddle)	50	0.05 M potassium chloride in 0.085 N hydrochloric acid, pH 1.2	500	10, 15, 20, 30, 45 and 60	10/06/2023
Modafinil	Tablet	II (Paddle)	50	0.1 N HCl	900	10, 20, 30, 45 and 60	02/10/2004
Moexipril HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Molindone HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Monomethyl Fumarate	Capsule (Delayed Release)	II (Paddle) Stationary Basket over the Paddle	100	Acid Stage: 0.1 N HCl; Buffer Stage: Phosphate buffer, pH 6.8		Acid Stage: 120; Buffer Stage: 15, 30, 45, 60, 90, 120 and 150	08/27/2020
Montelukast	Granule			Develop a dissolution method			09/15/2023
Montelukast Sodium	Tablet			Develop a dissolution method			09/15/2023
Montelukast Sodium	Tablet (Chewable)			Develop a dissolution method			09/15/2023
Morphine Sulfate	Tablet (Extended Release)	I (Basket)	100	Simulated Gastric Fluid [SGF] without enzyme	900	0.25, 0.5, 1, 1.5, 2, 4, 6 and 8 hours	10/20/2016
Morphine Sulfate	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Morphine Sulfate	Capsule (Extended Release)			Refer to USP			08/11/2008
Morphine Sulfate/Naltrexone HCl	Capsule (Extended Release)	II (Paddle)	50	Acid stage: 0.1 N HCl; Buffer stage: 0.05 Phosphate Buffer, pH 7.5	Acid stage: 500; Buffer stage: 500	Morphine Sulfate: Acid stage: 1 hour; Buffer stage: 1, 3, 5, 8 and 10 hours. Naltrexone HCl: Acid stage: 1 hour; Buffer stage: 1, 12, 24, 48, 73 and 96 hours.	01/26/2012
Moxifloxacin	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Mycophenolate Mofetil	Suspension	II (Paddle)	40	0.1 N HCl	900	5, 10, 20 and 30	02/10/2004
Mycophenolate Mofetil	Capsule	II (Paddle)	40	0.1 N HCl	900	5, 10, 20 and 30	02/10/2004
Mycophenolate Mofetil	Tablet	II (Paddle)	50	0.1 N HCl	900	5, 10, 15 and 30	02/10/2004
Mycophenolic acid	Tablet (Delayed Release)	II (Paddle)	50	Acid Stage: 0.1 N HCl; Buffer Stage: Buffer Solution, pH 6.8 (After initial 120 mins., 250 mL of 0.2 M sodium phosphate solution is added to acid stage medium. The pH of the mixture is adjusted to 6.8 using 0.2 M sodium phosphate, 2 N sodium hydroxide, or concentrated HCl acid solution if necessary.)	750 (Acid), 1000 (Buffer)	120 (Acid), 10, 20, 30, 45 and 60 (Buffer)	12/19/2008
Nabilone	Capsule	II (Paddle)	50	0.1% Tween 80 solution	1000	15, 30, 45 and 60	07/14/2008
Nabumetone	Tablet			Develop a dissolution method			01/03/2024
Nadolol	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Naldemedine	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Naloxegol Oxalate	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Naltrexone	Injectable Suspension			Phosphate buffered saline with 0.02% Tween 20 and 0.02% Sodium azide, pH 7.4 (final osmolality should be 270 ± 20 mOsm), or any other appropriate medium, at 37°C. Develop an in vitro release method using USP IV (Flow-Through Cell), and, if applicable, Apparatus II (Paddle) or any other appropriate method, for comparative evaluation by the Agency			09/01/2011
Naltrexone HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Naltrexone HCl / Oxycodone HCl	Capsule (Extended Release)			Develop a dissolution method			12/22/2016
Naltrexone HCl/Bupropion HCl	Tablet (Extended Release)			Develop a dissolution method			09/15/2023
Naproxen	Suspension			Develop a dissolution method			11/16/2017
Naproxen	Tablet (Delayed Release)			Refer to USP			12/15/2009
Naproxen	Tablet			Refer to USP			07/25/2007
Naproxen Sodium	Tablet (Extended Release)	II (Paddle)	50	Phosphate Buffer, pH 7.5	900	0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 14 hours	04/08/2010
Naproxen Sodium	Tablet			Refer to USP			10/04/2012
Naproxen Sodium	Capsule	II (Paddle)	75	Sodium Phosphate Buffer, pH 7.4 ± 0.05	900	10, 15, 20, 30 and 45	05/28/2015
Naproxen Sodium/Diphenhydramine HCl	Tablet	II (Paddle)	75	0.1M Sodium Phosphate buffer, pH 7.4 (deaerated)	900	5, 10, 15, 20 and 30	06/25/2015
Naproxen Sodium/Diphenhydramine HCl	Tablet	II (Paddle)	75	0.1M Sodium Phosphate Buffer, pH 7.4	900	5, 10, 15, 20, 30 and 45	05/28/2015
Naproxen Sodium/Sumatriptan Succinate	Tablet	I (Basket)	75	Phosphate Buffer, pH 6.8	900	10, 15, 20, 30 and 45	07/01/2010
Naproxen/Esomeprazole Magnesium	Tablet (Delayed Release)	II (Paddle) with sinkers	Naproxen::50 rpm Esomeprazole::75 rpm	Naproxen:: Acid Stage: 0.1M HCl; Buffer Stage: 0.05M Phosphate buffer, pH 6.8. Sampling for Acid stage: Transfer the un-dissolved tablet & sinker to the vessel containing the buffer stage medium. Add, 10 mL of 10 M NaOH to each vessel of the remaining acid stage medium. Continue rotation at 100 rpm for 30 minutes, withdraw aliquot and analyze. Esomeprazole (second set of tablets)(without pre-exposure to acid stage):: 0.05M Phosphate buffer, pH 7.4	Naproxen::Acid Stage: 1000; Buffer Stage: 1000; Esomeprazole::900	Naproxen:: Acid stage: 120; Buffer stage: 10, 20, 30, 45, 60, 75 and 90; Esomeprazole::10, 20, 30, 45, 60, 75 and 90	06/06/2013
Naratriptan HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Nateglinide	Tablet	II (Paddle)	50	0.01 N HCl with 0.5% (w/v) SLS	1000	10, 20, 30 and 45	01/03/2007
Nebivolol HCl	Tablet	II (Paddle)	50	0.01 N HCl	900	10, 20, 30 and 45	01/15/2010
Nebivolol/Valsartan	Tablet	I (Basket)	100	67 mM Phosphate Buffer pH 6.8 with 0.5% SDS	900	5, 10, 15, 20 and 30	10/20/2016
Nefazodone HCl	Tablet	II (Paddle)	50	0.1 N HCl	900	10, 20, 30, 45 and 60	01/03/2007
Nelfinavir Mesylate	Tablet	II (Paddle)	50	0.1 N HCl	900	5, 10, 15, 20, 30, 45, 60 and 90	01/03/2007
Nelfinavir Mesylate	Powder for Suspension	II (Paddle)	50	0.1 N HCl	900	5, 10, 15, 20, 30, and 45	09/13/2007
Neomycin Sulfate	Tablet	II (Paddle)	50	0.05 M Phosphate Buffer, pH 6.8	900	15, 30, 45 and 60	01/14/2008
Nepafenac	Ophthalmic Suspension			Develop a method to characterize in vitro release			08/14/2014
Netupitant/Palonosetron HCl	Capsule	II (Paddle)	Netupitant:100; Palonosetron: 75	Netupitant: 0.07M Phosphate buffer pH 6.8 containing 1% sodium SDS ; Palonosetron: 0.01 N HCl	Netupitant: 900; Palonosetron: 500	Netupitant: 10, 20, 30, 45, 60 and 75; Palonosetron: 5, 10, 15, 20, 30 and 45	09/03/2015
Nevirapine	Suspension	II (Paddle)	25	0.1 N HCl	900	10, 20, 30, 45 and 60	02/11/2004
Nevirapine	Tablet			Refer to USP			09/13/2007
Nevirapine	Tablet (Extended Release)	I (Basket)	75	0.04 M Sodium phosphate buffer pH 6.8 containing 2% sodium lauryl sulfate	900	1, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 20 hours	01/31/2013
Niacin	Tablet (Extended Release)			Develop a dissolution method			09/15/2023
Niacin/Simvastatin	Tablet (Extended Release)	Simvastain: I (10 mesh rotating Basket)	100	Niacin: Develop a dissolution method; Simvastatin: 0.5 % SDS in 0.01 M Sodium Phosphate, pH 7.0	900	Simvastatin: 10, 20, 30, 45 and 60	09/15/2023
Nicardipine HCl	Capsule	II (Paddle)	50	0.033 M Citric Acid Buffer, pH 4.5	900	10, 20, 30 and 45	02/11/2004
Nicardipine HCl	Capsule (Extended Release)	II (Paddle)	50	0.1 N HCl	1000	0.5 , 2 and 6 hours	07/14/2008
Nicotine	Film, Transdermal (Extended Release)			Develop a dissolution method			01/03/2024
Nicotine Polacrilex	Lozenge (Mini)	III (Reciprocating Cylinder)	20 dpm	Phosphate buffer pH 7.4	250	15, 30, 45, 60 and 90	03/09/2017
Nicotine Polacrilex	Chewing Gum	Chewing Machine as desribed in European Pharmacopoeia (2.9.25)	60 cycles (chews) per minute	Phosphate Buffer, pH 7.4 or or any other appropriate buffer and conditions	20	5, 10, 20 and 30	01/05/2012
Nicotine Polacrilex	Lozenge	I (Basket)	100	Phosphate Buffer, pH 7.4	900	0.5, 1, 2, 3, 6 and 8 hours	12/23/2010
Nifedipine	Capsule			Refer to USP			03/03/2011
Nifedipine	Tablet (Extended Release)			Develop a dissolution method			01/03/2024
Nifurtimox	Tablet	II (Paddle)	100	Acetate buffer pH 4.5 with 1% sodium dodecyl sulfate (SDS) for 30 mg strength and 1.5 % SDS for 120 mg strength	900	15, 30, 45, 60, 90 and 120	02/09/2023
Nifurtimox	Tablet	II (Paddle)	100	Acetate Buffer, pH 4.5 with 1.0 % Sodium Dodecyl Sulfate (SDS) (for 30 mg strength) and 1.5 % SDS (for 120 mg strength)	900	10, 20, 30, 60 and 75	07/07/2022
Nilotinib HCl	Capsule	I (Basket)	100	0.1 N HCl	1000	10, 15, 20, 30 and 45	02/05/2024
Nilotinib Hydrochloride Monohydrate	Capsule	I (Basket)	100	0.1 N HCl	1000	10, 15, 30 and 45	10/30/2009
Nilutamide	Tablet			Develop a dissolution method			05/20/2009
Nimodipine	Capsule			Develop a dissolution method			09/15/2023
Nintedanib Esylate	Capsule	II (Paddle) with sinker	100	0.1 N HCl	900	10, 15, 20, 30, 45 and 60	09/03/2015
Niraparib	Capsule	II (Paddle) with sinker	50	Tier 1: 0.08M Sodium Acetate Buffer, pH 4.0; Tier 2: 0.08M Sodium Acetate Buffer, pH 4.0 containing pepsin (750,000 units/L)	900	10, 15, 20, 30, 45 and 60	11/02/2017
Niraparib Tosylate	Tablet	II (Paddle)	60	0.1 M Citrate buffer, pH 4.6	900	5, 10, 15, 20, 25, 30 and 45	02/05/2024
Nirmatrelvir (NIR); Ritonavir (RIT)	Tablet (copackage)	II (Paddle)	75	NIR: 0.05 M Sodium Phosphate, pH 6.8 with 0.2% Sodium Dodecyl Sulfate; RIT: Refer to USP	900	15, 20, 30, 45 and 60	08/05/2024
Nisoldipine	Tablet (Extended Release)	II (Paddle) with option to use a sinker	50	HCl with SLS (32.5 ± 0.1 g Sodium Lauryl Sulfate in 6489 mL of purified water containing 17.0 mL HCl, pH adjusted to 1.20 ± 0.05 with HCl)	900	1, 4, 8, 12, 15, 18 and 24 hours	04/02/2009
Nitazoxanide	Tablet	II (Paddle)	75	Phosphate buffer at pH 7.5 with 6% hexadecyltrimethyl ammonium bromide, bath temperature at 25ºC	900	10, 20, 30, 45, 60	01/03/2007
Nitazoxanide	Oral Suspension	II (Paddle	100	Phosphate buffer at pH 7.5 with 6% hexadecyltrimethyl ammonium bromide, bath temperature at 25ºC	900	10, 20, 30, 45 and 60	10/21/2010
Nitisinone	Capsule	II (Paddle) with sinker	50	Phosphate Buffer, pH 6.8	1000	5, 10, 15, 20, 30 and 45	11/02/2017
Nitisinone	Tablet	II (Paddle)	50	Phosphate Buffer, pH 6.8	2 mg tablets: 500 mL; 5 mg and 10 mg tablets: 900 mL	10, 15, 20, 30, 45, 60, 75 and 90	02/15/2018
Nitisinone	Suspension	II (Paddle)	50	pH 1.2 HCl Buffer (degassed)	1000	10, 15, 20, 30 and 45	12/22/2016
Nitrofurantoin	Capsule			Refer to USP			04/02/2009
Nitrofurantoin	Suspension	II (Paddle)	50	Phosphate Buffer, pH 7.2	900	15, 30, 60, 120 and 180	04/02/2009
Nitroglycerin	Tablet (Sublingual)	II (Paddle)	50	Phosphate Buffer, pH 6.5	500	1, 3, 5, 8, and 10	01/15/2010
Nitroglycerin	Film, Transdermal (Extended Release)	Modified USP Type V (Paddle-over-disk)	100	Deionized Water at 32º C	900	10, 20, 30, 45, 60, 90, 120 and 180	04/08/2010
Nizatidine	Capsule			Develop a dissolution method			01/03/2024
Norethindrone	Tablet			Refer to USP			10/08/2009
Norethindrone Acetate	Tablet			Refer to USP			08/27/2009
Nortriptyline HCl	Capsule			Develop a dissolution method			01/03/2024
Nystatin	Oral Suspension			Develop a dissolution method			09/15/2023
Nystatin	Tablet			Develop a dissolution method			09/15/2023
Obeticholic Acid	Tablet	II (Paddle)	75	0.08% polysorbate 80 in 50mM sodium phosphate dibasic buffer, pH 6.8	900	5, 10, 15, 20, 30 and 45	11/02/2017
Octreotide Acetate	Capsule (Delayed Release)	II (Paddle with sinker)	50	Acid stage: 0.1N HCl ; Buffer stage: pH 6.8 buffer	Acid stage: 900; Buffer stage: 900	Acid stage: 120; Buffer stage: 10, 20, 30 45 and 60	04/22/2021
Octreotide Injection	Injectable (Extended Release)			Develop a dissolution method using USP IV (Flow-Through Cell), and, if applicable, Apparatus II (Paddle) or any other appropriate method, for comparative evaluation by the Agency			12/23/2010
Ofloxacin	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Olanzapine	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Olanzapine	Tablet (Orally Disintegrating)			Refer to USP			01/15/2015
Olanzapine Pamoate	For Intramuscular Suspension (Extended Release)	IV (Flow through cell), 22.6 mm cell	Flow @ 3 mL/min	1% SLS in pH 6.8 Phosphate Buffer	use Open Mode	10, 20, 30, 45, 60, 75, 90, 105, 120, 150, 180, 240, 360, 480, 600, and 720	12/24/2015
Olanzapine; Samidorphan L-malate	Tablet			Refer to FDA's Dissolution Guidance, 2018			05/18/2023
Olaparib	Tablet	I (Basket)	100	50 mM Phosphate Buffer, pH 6.8	900	15, 30, 45 and 60	02/16/2024
Olmesartan Medoxomil	Tablet			Refer to USP			11/02/2017
Olsalazine Sodium	Capsule	I (Basket)	100	Phosphate Buffer, pH 7.5	900	10, 20, 30 and 45	02/12/2004
Olutasidenib	Capsule	II (Paddle) with sinkers	65	McIlvaine Buffer, pH 2.2 W/ 1.25% SDS	500	10, 15, 30, 45, and 60	02/05/2024
Omaveloxolone	Capsule	I (Basket)	100	50 mM Sodium Phosphate Buffer, pH 6.8	900	10, 15, 20, 30, 45 and 60	05/31/2024
Ombitasvir/ Paritaprevir/ Ritonavir and Dasabuvir Sodium	Tablet	II (Paddle)	75	Ombitasvir, paritaprevir, ritonavir: 0.05 M sodium phosphate buffer, pH 6.8 with 0.3% polyoxyethylene 10 lauryl ether; Dasabuvir sodium: 0.05 M Sodium Phosphate buffer, pH 6.8 with 15 mM cetyl triethylammonium bromide (CTAB)	900	Ombitasvir, paritaprevir, ritonavir: 10, 20, 30, 45, 60, 90, 120 and 150; Dasabuvir: 5, 10, 15, 20 and 30	08/27/2015
Ombitasvir/Paritaprevir/Ritonavir	Tablet	II (Paddle) with sinker	75	0.05M Sodium Phosphate Buffer, pH 6.8 with 0.3% (w/v) Polyoxyethylene 10 Lauryl Ether (POE10LE)	900	10, 20, 30, 45, 60, 90, 120, 150 and 180	06/30/2016
Omega-3-Acid Ethyl Esters	Capsule			Develop an in vitro release method using USP IV (Flow-Through Cell), and, if applicable, Apparatus II (Paddle) or any other appropriate pharmacopoeial apparatus, for comparative evaluation by the Agency.			03/17/2016
Omeprazole	Capsule (Delayed Release)			Refer to USP			06/18/2007
Omeprazole	OTC Tablet (Delayed Release)	II (Paddle)	100	Tablets are pre-exposed to 750 ml of 0.1M HCL for 2 hrs and then 250 ml of 0.2M Na3PO4 is added to the medium to give 1000 ml with pH 6.8	Acid stage: 750; Buffer stage: 1000	Acid stage: 120; Buffer stage: 10, 20, 30, 45 and 60	02/28/2013
Omeprazole (Orally Disintegrating)	OTC Tablet (Delayed Release)	II (Paddle)	100	Tablets are pre-exposed to 500 ml of 0.1M HCL for 2 hrs and then 400 ml of 0.235M Na2HP04 is added to the medium. Adjust if necessary with 2 N HCI or 2 N NaOH to a pH of 6.8	Acid stage: 500; Buffer stage: 900	Acid stage: 120; Buffer stage: 10, 20, 30, 45 and 60	02/08/2018
Omeprazole Magnesium	For suspension (Delayed Release)	II (Paddle)	100	Pre-exposed to 300 mL of 0.1M HCl for 2 hrs and then 700 mL of 0.086 M Na2HPO4 is added to the medium to give 1000 mL with pH 6.8	Acid stage: 300; Buffer stage: 1000	Acid stage: 120; Buffer stage: 10, 20, 30, 45 and 60	02/07/2019
Omeprazole Magnesium	Capsule, Delayed Release	II (Paddle)	100	Acid stage: 0.1 N HCl (deaerated) for 2 hrs; Buffer stage: Phosphate buffer (deaerated), pH 6.8		Acid stage: 120; Buffer stage: 10, 20, 30 and 45	03/30/2023
Omeprazole Magnesium	OTC Tablet (Delayed Release)	II (Paddle)	100	Tablets are pre-exposed to 300 mL of 0.1M HCL for 2 hrs and then 700 mL of 0.086 M Na2HPO4 is added to the medium containing the capsule to give 1000 mL with pH 6.8	300 ml for the acid stage; 1000 ml for the buffer stage	Sampling started at the buffer stage 10, 20, 30, 45 and 60	01/03/2007
Omeprazole Sodium Bicarbonate	Capsule	II (Paddle)	75	Phosphate Buffer, pH 7.4	900	15, 30, 45 and 60	07/14/2008
Omeprazole Sodium Bicarbonate	Powder for suspension (Immediate Release)	II (Paddle)	50	0.25 mM Sodium Phosphate Buffer, pH 7.4	900	5, 10, 15, and 30	06/20/2007
Ondansetron	Tablet (Orally Disintegrating)			Refer to USP			06/18/2007
Ondansetron	Film (Oral)	V (Paddle over Disk) with a stainless steel disk (120 mesh screens)	50	0.1 N HCl	900	5, 10, 15, 20 and 30	01/26/2012
Ondansetron HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Opicapone	Capsule	I (Basket with sinker)	100	Tier 1: 0.05 M Phosphate Buffer, pH 6.8 with 1% cetrimide; Tier 2: Stage 1: 0.05 M Phosphate Buffer, pH 6.8 with pancreatin (1750 USP units/L); Stage 2: after 10 minutes of Stage 1, add 100 mL of 10% cetrimide.		5, 10, 15, 20, 30 and 45	05/12/2022
Orlistat	Capsule	II (Paddle)	75	3% SLS in 0.5% Sodium Chloride, pH 6.0	900	10, 20, 30, 45 and 60	02/12/2004
Orphenadrine Citrate	Tablet (Extended Release)			Develop a dissolution method			01/03/2024
Oseltamivir Phosphate	Oral Suspension	II (Paddle)	25	0.1 N HCl	900	5, 10, 15, 20 and 30	07/15/2009
Oseltamivir Phosphate	Capsule			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Osilodrostat Phosphate	Tablet			Refer to FDA's Dissolution Guidance, 2018			08/19/2021
Osimertinib Mesylate	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Ospemifene	Tablet			Develop a dissolution method			09/15/2023
Oteseconazole	Capsule	II (Paddle) with sinker	75	Tier 1: Stage 1: 0.01N HCl; Stage 2: After 15 minutes, add 150 mL of 3.0% SLS Tier 2: Stage 1: Pepsin (750,000 units/L) in 0.01N HCl; Stage 2: After 15 minutes, add 150 mL of 3.0% SLS		20, 30, 45 and 60	10/06/2023
Oxandrolone	Tablet			Refer to USP			02/09/2023
Oxaprozin	Tablet			Refer to USP			03/17/2016
Oxazepam	Capsule			Refer to USP			05/31/2024
Oxcarbazepine	Suspension			Develop a dissolution method			09/15/2023
Oxcarbazepine	Tablet			Develop a dissolution method			09/15/2023
Oxcarbazepine	Tablet (Extended Release)			Develop a dissolution method			09/15/2023
Oxybutynin	Trans-dermal	Paddle over Disk (Apparatus 5)	50	Phosphate Buffer, pH 4.5 @ 32oC	900	1, 4, 24 hours	01/03/2007
Oxybutynin Chloride	Tablet (Extended Release)			Refer to USP			12/24/2015
Oxycodone	Capsule (Extended Release)	I (Basket)	100	22 mM Sodium Acetate buffer, pH 4.5 with 0.03% Tween 20	900	1, 2, 4, 6, 8, 12, 16, 20 and 24 hours	07/28/2016
Oxycodone HCl	Capsule			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Oxycodone HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Oxycodone HCl	Tablet (Extended Release)			Refer to USP			03/17/2016
Oxycodone HCl/ Naloxone HCl	Tablet (Extended Release)	II (Paddle)	50	Simulated Gastric Fluid [SGF, pH 1.2] without enzyme	900	0.25, 0.5, 1, 2, 4, 6, 8, 10 and 12 hours	12/22/2016
Oxymorphone HCl	Tablet (Extended Release)	II (Paddle) with sinker	50	45 mM Phosphate Buffer, pH 4.5	900	1, 2, 4, 6, 8 and 10 hours	02/14/2014
Oxymorphone HCl	Tablets			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Ozanimod HCl	Capsule			Refer to FDA's Dissolution Guidance, 2018			05/12/2022
Pacritinib Citrate	Capsule	II (Paddle) with sinker	75	0.08 M HCl/0.034 M NaCl, pH 1.2	900	5, 10, 15 and 30	05/18/2023
Palbociclib	Tablet	II (Paddle)	75	0.1 N HCl	900	10, 15, 20, 30 and 45	08/19/2021
Palbociclib	Capsule	II (Paddle) with sinker	50	0.1 N HCl	900	10, 15, 20, 30 and 45	03/17/2016
Paliperidone	Tablet (Extended Release)	II (Paddle)	50	Modified SGF, pH 1.0 [NaCl (0.2% w/w) in 0.0825N HCl]	500	1, 2, 4, 6, 8, 12, 14, 18 and 24 hours	08/27/2009
Paliperidone Palmitate	Intramuscular Suspension (Extended Release)	II (Paddle)	50	0.489% (w/v) Polysorbate 20 in 0.001 N HCl @25.0 °C.	900	1.5, 5, 8, 10, 15, 20, 30 and 45	09/01/2011
Paliperidone Palmitate [3-month injection]	Intramuscular Suspension (Extended Release)	II (Paddle)	50	0.489% (w/v) Polysorbate 20 in 0.001 N HCl @25.0 °C.	900	5, 30, 60, 90, 120, 180, 240, 300 and 360	03/17/2016
Palonosetron HCl	Capsule			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Pancrelipase	Capsule (Delayed Release)			Refer to USP			03/17/2016
Pancrelipase	Tablet	II (Paddle)	50	Phosphate Buffer, pH 4.5	900	10, 20, 30, 45 and 60	06/02/2016
Panobinostat Lactate	Capsule			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Pantoprazole Sodium	Tablet (Delayed Release)			Refer to USP			07/21/2009
Pantoprazole Sodium	Delayed Release Granules for Oral Suspension	II (Paddle)	100	Acid Stage: 0.1 N Hydrochloric Acid; Buffer Stage: 0.05 M Tribasic Sodium Phosphate (Add 250 mL of 0.2 mM Tribasic Sodium Phosphate after completion of acid stage); pH 6.8 (Method B)	Acid stage: 750; Buffer stage: 1000	Acid stage: 60, 90 and 120; Buffer stage: 10, 20, 30, 45 and 60	10/30/2009
Paricalcitol	Capsule	I (Basket)	100	4 mg/mL (0.4%) Lauryldimethylamine N-oxide (LDAO)	500	20, 30, 45, 60	06/18/2007
Paromomycin Sulfate	Capsule			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Paroxetine	Tablet (Extended Release)			Refer to USP			11/19/2015
Paroxetine HCl	Suspension	II (Paddle)	100	SGF without enzyme	900	10, 20, 30 and 45	02/13/2004
Paroxetine HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Paroxetine Mesylate	Capsule			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Paroxetine Mesylate	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Patisiran Sodium	Solution	II (Paddle)	25	Tris/EDTA buffer, pH 7.5 with 0.02% Tween 20	500	2, 5, 7, 11 and 15	03/30/2023
Pazopanib HCl	Tablet	II (Paddle)	75	50 mM Sodium Acetate buffer, pH 4.5, containing 0.75% SDS	900	10, 15, 30, 45 and 60	08/05/2010
Pemigatinib	Tablet	I (Basket)	50	0.01 N HCl	500	5, 10, 15, 20, 30 and 45	05/12/2022
Pemoline	Tablet			Develop a dissolution method			09/15/2023
Penbutolol Sulfate	Tablet			Refer to USP			06/24/2010
Penicillamine	Capsule			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Penicillin G Benzathine	Injectable			Develop a method to characterize in vitro release			08/19/2021
Penicillin V	Tablet			Refer to USP			06/09/2011
Penicillin V Potassium	Tablet			Refer to USP			06/09/2011
Pentosan Polysulfate Sodium	Capsule			Develop a dissolution method			09/15/2023
Pentoxifylline	Tablet (Extended Release)			Develop a dissolution method			01/03/2024
Perampanel	Suspension	II (Paddle)	50	0.1 N HCl	900 [890 mL 0.1 N HCl + 10 mL perampanel suspension]	5, 10, 15, 20 and 30	12/22/2016
Perampanel	Tablet	II (Paddle)	50	0.1 N HCl	900	5, 10, 15, 20 and 30	05/15/2014
Pergolide Mesylate	Tablet	II (Paddle)	50	Simulated gastric fluid TS with cysteine without enzymes	500	10, 20, 30 and 45	03/04/2006
Perindopril Erbumine	Tablet	II (Paddle)	50	0.1 N HCl	900	10, 20 , 30 and 45	06/20/2007
Perphenazine	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Phendimetrazine Tartrate	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Phendimetrazine Tartrate	Capsule			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Phendimetrazine Tartrate	Capsule (Extended Release)	II (Paddle)	50	1 hour - SGF w/o Enzymes; after 1 hour - SIF w/o Enzymes	900	1, 2, 4, 6 and 8 hours	06/10/2009
Phenelzine Sulfate	Tablet	II (Paddle)	50	Simulated Gastric Fluid without enzymes, pH 1.2	900	10, 20, 30 and 45	03/25/2010
Phenoxybenzamine HCl	Capsule			Refer to USP			04/10/2008
Phentermine HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Phentermine HCl	Tablet (Orally Disintegrating)			Develop a dissolution method			09/15/2023
Phentermine HCl	Capsule			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Phentermine HCl/Topiramate	Capsule (Extended Release)			Develop a dissolution method			09/15/2023
Phenytoin	Suspension			Refer to USP			06/18/2007
Phenytoin	Tablet (Chewable)			Develop a dissolution method			01/03/2024
Phenytoin Sodium	Capsule			Develop a dissolution method			01/03/2024
Phytonadione	Tablet			Develop a dissolution method			03/25/2010
Pilocarpine HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Pimavanserin Tartrate	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Pimozide	Tablet			Refer to USP			02/19/2008
Pindolol	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Pioglitazone HCl	Tablet	II (Paddle)	75	HCl-0.3 M KCl Buffer, pH 2.0	900	5, 10, 15 and 30	02/13/2004
Pirfenidone	Capsule			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Pirfenidone	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Piroxicam	Capsule			Refer to USP			10/04/2012
Pirtobrutinib	Tablet	II (Paddle)	75	Sodium Phosphate Buffer, pH 6.8	900	5, 10, 15, 20, 30, 45 and 60	05/31/2024
Pitavastatin Calcium	Tablet	I (Basket)	35	0.05 M Phosphate Buffer, pH 6.8	900	5, 10, 15, 20, 30 and 45	12/23/2010
Pomalidomide	Capsule	II (Paddle)	50	0.1 N HCl	900	10, 15, 20, 30 and 45	05/28/2015
Ponatinib HCl	Tablet	I (Basket)	50	pH 2.1, KCl/HCl buffer (degassed)	900	10, 15, 20, 30, 45 and 60	09/03/2015
Posaconazole	For Suspension (Delayed Release)	II (Paddle)	75	Acid stage: 0.01 N HCl; Buffer stage: pH 6.8 Phosphate buffer with 1.3% Tween 80;	Acid stage: 750 mL; Buffer stage: 1000 mL	Acid stage: 120; Buffer stage: 5, 10, 15, 20, 30 and 45	07/07/2022
Posaconazole	Tablet (Delayed Release)	II (Paddle)	75	Acid Stage: 0.01 N HCl: Buffer Stage: 50 mM phosphate buffer, pH 6.8 with 0.37 % Polysorbate 80 (after 120 minutes, to the acid stage, add 250 mL of 0.2M Phosphate Buffer, 1.46% Polysorbate 80)	Acid Stage: 750 mL; Buffer Stage 1000 mL	Acid Stage: 120; Buffer Stage: 10, 15, 20, 30 and 45	06/25/2015
Posaconazole	Oral Suspension	II (Paddle)	25	0.3% SLS	900	10, 20, 30 and 45	12/03/2007
Potassium Chloride	Tablet (Extended Release)			Develop a dissolution method			01/03/2024
Potassium Chloride	Capsule (Extended Release)			Develop a dissolution method			01/03/2024
Potassium Citrate	Tablet			Develop a dissolution method			01/03/2024
Pralsetinib	Capsule	II (Paddle) with sinker	50	50 mM Sodium Phosphate Buffer, pH 6.8, with 0.4% w/v Cetyl Trimethylammonium Bromide (CTAB)	900	10, 20, 30, 45 and 60	07/07/2022
Pramipexole Dihydrochloride	Tablet (Extended Release)	I (Basket)	100	0.05 M phosphate buffer, pH 6.8	500	1, 2, 4, 6, 9, 12, 16, 20 and 24 hours	09/02/2010
Pramipexole Dihydrochloride	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Prasugrel HCl	Tablet	II (Paddle)	75	Citrate-Phosphate buffer (0.023M Citric acid+0.026M Sodium Phosphate, Dibasic), pH 4.0	900	10, 15, 20, 30 and 45	10/04/2012
Pravastatin Sodium	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Praziquantel	Tablet			Refer to USP			06/25/2015
Prazosin HCl	Capsule			Refer to USP			05/12/2022
Prednisolone	Tablet			Develop a dissolution method			01/03/2024
Prednisolone Acetate	Ophthalmic Suspension			Develop an in vitro release method			05/15/2014
Prednisolone Sodium Phosphate	Tablet (Orally Disintegrating)	II (Paddle)	50	22 mM Sodium Acetate Buffer, pH 4.5	500	5, 15, 30, 45 and 60	09/03/2008
Prednisone	Tablet			Develop a dissolution method			01/03/2024
Prednisone	Tablet (Delayed Release)			Develop a dissolution method			09/15/2023
Pregabalin	Capsule			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Pregabalin	Tablet (Extended Release)	II (Paddle)	50	0.06 M HCl	900	1, 2, 4, 6, 8, 10, 12, 16 and 24 hours	02/08/2018
Pretomanid	Tablet	II (Paddle)	75	0.1 N HCl with 0.5% hexadecyltrimethylammonium (HDTMA)	1000	5, 10, 15, 20, 30 and 45	04/22/2021
Primaquine Phosphate	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Primidone	Tablet			Develop a dissolution method			11/30/2023
Primidone	Tablet			Develop a dissolution method			01/03/2024
Procarbazine HCl	Capsules			Develop a dissolution method			09/15/2023
Prochlorperazine	Rectal Suppository	I (Suppository, dissolution baskets, palmieri type)	100	0.1 N HCl at 38° C	900	10, 20, 30 and 45	08/17/2006
Prochlorperazine Maleate	Tablet	II (Paddle)	75	0.1 N HCl	500	10, 20, 30, 45, 60, 75, and 90	04/22/2021
Progesterone	Capsule			Develop a quantitative rupture test			04/08/2010
Progesterone	Gel	I (Basket) with Diacell sample holder	100	Methanol:water 20:80	1000	2, 4, 8, 12, 20, 24, 48 and 72 hours	03/30/2023
Progesterone	Vaginal Insert	II (Paddle)	50	0.25% sodium dodecyl sulfate (SDS) in DI water	900	5, 10, 15, 20 and 30	10/04/2012
Promethazine HCl	Rectal Suppository			Develop a method to characterize in vitro release			10/20/2016
Promethazine HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Propafenone HCl	Tablet			Refer to USP			11/02/2017
Propafenone HCl	Capsule (Extended Release)			Refer to USP			11/02/2017
Propranolol HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018			04/22/2021
Propranolol HCl	Capsule (Extended Release)			Refer to USP			07/25/2007
Propylthiouracil	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Protriptyline HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Protriptyline HCl	Tablet			Develop a dissolution method			01/03/2024
Prucalopride Succinate	Tablet			Refer to FDA's Dissolution Guidance, 2018			04/22/2021
Pseudoephedrine HCl	Tablet (Extended Release)			Develop a dissolution method			01/03/2024
Pseudoephedrine HCl/Triprolidine HCl	Tablet			Develop a dissolution method			01/03/2024
Pyrazinamide	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Pyridostigmine Bromide	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Pyridostigmine Bromide	Tablet (Extended Release)			Develop a dissolution method			09/15/2023
Pyrimethamine	Tablet			Refer to USP			06/25/2015
Quetiapine Fumarate	Tablet (Extended Release)	I (Basket, with 20 mesh)	200	0.05M citric acid and 0.09 N NaOH (pH 4.8) [solution A]. At 5 hrs, pH adjusted to 6.6 by addition of 100 mL of 0.05M dibasic sodium phosphate and 0.46N NaOH [solution B]	900 [solution A]. 1000 [final]	1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 hours	01/31/2013
Quetiapine Fumarate	Tablet			Develop a dissolution method			09/15/2023
Quinapril HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Quinidine Gluconate	Tablet (Extended Release)			Refer to USP			04/22/2021
Quinine Sulfate	Capsule			Refer to USP			01/14/2008
Rabeprazole Sodium	Tablet (Delayed Release)	II (Paddle)	100	700 mL 0.1 N HCl (Acid stage), after two hours add 300 mL of 0.6 M Tris buffer; adjust to pH 8.0 (Buffer stage) with 2 N HCl or 2 N NaOH . Stabilize the samples with the addition of 0.5 N NaOH	Acid stage: 700; Buffer stage: 1000	Acid stage: 120; Buffer stage: 10, 20, 30, and 45	09/22/2011
Rabeprazole Sodium	Capsule (Delayed Release)	II (Paddle)	Acid Stage: 75 rpm; Buffer Stage: 60 rpm	Acid Stage:0.1 N HCl; Buffer Stage: 0.05 M Phosphate Buffer, pH 6.8 (After Acid Stage, add 250 mL of 0.2 mol/L trisodium phosphate solution).	Acid Stage: 750; Buffer Stage:1000	Acid Stage: 120; Buffer Stage: 10, 15, 20, 25, 30 and 45	05/15/2014
Raloxifene HCl	Tablet			Develop a dissolution method			09/15/2023
Raltegravir Potassium	Tablet (Chewable)			Develop a dissolution method			09/15/2023
Raltegravir Potassium	Tablet			Develop a dissolution method			09/15/2023
Ramelteon	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Ramipril	Capsule			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Ramipril	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Ranitidine HCl	Tablet			Develop a dissolution method			01/03/2024
Ranitidine HCl	Tablet (Effervescent)			Develop a dissolution method			04/08/2010
Ranitidine HCl	Capsule			Develop a dissolution method			09/15/2023
Ranolazine	Granules (Extended Release)	II (Paddle)	50	0.1 N HCl	900	0.5, 1, 2, 3, 4, 6 and 8 hours	07/07/2022
Ranolazine	Tablet (Extended Release)			Develop a dissolution method			02/07/2019
Rasagiline Mesylate	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Regorafenib	Tablet	II (Paddle)	75	Acetate Buffer pH 4.5 with 0.1% Sodium Dodecyl Sulfate (SDS)	900	10, 15, 20, 30 and 45	06/25/2015
Relugolix	Tablet	II (Paddle)	50	50 mM Citrate Buffer, pH 5.5	900	5, 10, 15, 20 and 30	07/07/2022
Repaglinide	Tablet			Refer to USP			07/25/2007
Resmetirom	Tablet			Develop a dissolution method			09/03/2024
Ribavirin	Tablet			Develop a dissolution method			09/15/2023
Ribavirin	Capsule			Develop a dissolution method			09/15/2023
Ribociclib	Tablet	II (Paddle)	50	0.01N HCl (degassed)	900	10, 20, 30, 45 and 60	05/12/2022
Rifabutin	Capsule			Refer to USP			12/15/2009
Rifampin	Capsule			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Rifamycin Sodium	Tablet (Delayed Release)	II (Paddle)	100	Acid stage: HCl 0.1 N with 0.5% w/v Macrogol Cetostearyl Ether; Buffer stage: pH 7.2 Sodium Phosphate buffer		Acid Stage: 2 hours; Buffer Stage: 1, 2, 3 and 4 hours	04/22/2021
Rifapentine	Tablet	II (Paddle)	50	0.8% SLS in Phosphate Buffer, pH 7.0	900	10, 20, 30, 45, 60 and 90	02/25/2004
Rifaximin (200 mg)	Tablet	II (Paddle)	75	0.1M sodium phosphate buffer pH 7.4 containing 0.45% Sodium Lauryl Sulfate	1000	10, 20, 30, 45, 60, 90 and 120	07/21/2011
Rifaximin (550 mg)	Tablet	II (Paddle)	75	0.1M sodium phosphate buffer pH 7.4 containing 0.8% Sodium Lauryl Sulfate	1000	10, 20, 30, 45, 60, 90 and 120	07/21/2011
Rilpivirine HCl	Tablet	II (Paddle)	75	0.5% Polysorbate 20 in 0.01N HCl (pH=2.0)	900	10, 20, 30, 45 and 60	08/15/2013
Riluzole	Suspension	II (Paddle)	35	Phosphate Buffer pH 4.5	900 [890 mL of medium + 10 mL of suspension]	5, 10, 20, 30, 45 and 60	05/12/2022
Riluzole	Tablet	II (Paddle)	50	0.1 N HCl	900	10, 20, 30, 45 and 60	02/18/2004
Rimantadine HCl	Tablet			Develop a dissolution method			09/15/2023
Rimegepant Sulfate	Tablet, (Orally Disintegrating (ODT))	II (Paddle)	50	50 mM Sodium Acetate Buffer, pH 4.5	500	5, 10, 15, 20 and 30	05/12/2022
Rimexolone	Ophthalmic Suspension			Develop a method to characterize in vitro release			06/30/2016
Riociguat	Tablet	II (Paddle)	75	pH 6.8 Phosphate Buffer with 0.1% Sodium Lauryl Sulfate [SLS]	900	5, 10, 15, 20 and 30	12/24/2015
Ripretinib	Tablet	II (Paddle)	75	10 mM Sodium Acetate Buffer, pH 4.5, containing 0.25% (w/v) sodium dodecyl sulfate (SDS)	900	5, 10, 15, 20, 30 and 45	05/12/2022
Risedronate Sodium	Tablet (Delayed Release)	II (Paddle)	75	Acid stage: 0.1 N HCl; Buffer stage: Phosphate buffer, pH 6.8	Acid stage: 500; Buffer stage: 500	Acid stage: 120; Buffer Stage: 10, 15, 20, 30 and 45	01/26/2012
Risedronate Sodium	Tablet			Develop a dissolution method			01/03/2024
Risedronate Sodium/Calcium Carbonate	Tablet (Copackaged)			For Risedronate Tablets: Refer to USP; For Calcium Carbonate Tablets: Refer to USP.			07/01/2010
Risperidone	For Suspension (Extended Release)			Develop a dissolution method using USP IV (Flow-Through Cell), and, if applicable, Apparatus II (Paddle) or any other appropriate method, for comparative evaluation by the Agency			01/15/2010
Risperidone	Tablet	II (Paddle)	50	0.1 N HCl	500	10, 20, 30, 45 and 60	03/04/2006
Risperidone	Tablet (Orally Disintegrating)	II (Paddle)	50	0.1 N HCl	500	5, 10, 15	07/23/2004
Ritonavir	Tablet			Refer to USP			01/15/2015
Ritonavir	Capsule			Refer to USP			01/15/2015
Ritonavir	Powder	I (Basket -100 mesh)	100	0.1 N HCl	900	5, 10, 15, 20 and 30	11/16/2017
Rivaroxaban (10 mg)	Tablet	II (Paddle)	75	Acetate Buffer pH 4.5, 0.2% sodium dodecyl sulfate (SDS)	900	10, 15, 20, 30 and 45	01/15/2015
Rivaroxaban (15 and 20 mg)	Tablet	II (Paddle)	75	Acetate Buffer pH 4.5, 0.4% SDS	900	10, 15, 20, 30 and 45	01/15/2015
Rivaroxaban (2.5 mg)	Tablet	II (Paddle)	75	Acetate Buffer pH 4.5	900	10, 15, 20, 30 and 45	02/07/2019
Rivastigmine	Film, Transdermal	Modified USP Type VI (cylinder)	50	0. 9 % NaCl at 32º C	500	1, 2, 4, 7, 9 and 12 hours	06/10/2009
Rivastigmine Tartrate	Capsule			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Rizatriptan Benzoate	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Rizatriptan Benzoate	Tablet, (Orally Disintegrating (ODT))			Develop a dissolution method			01/03/2024
Roflumilast	Tablet	II (Paddle)	50	1.0% SDS (sodium dodecyl sulfate) in Phosphate Buffer, pH 6.8	1000	5, 10, 15, 20, 30 and 45	08/15/2013
Rolapitant HCl	Tablet	II (Paddle)	50	0.05 M Sodium Acetate buffer, pH 4.0	900	10, 15, 20, 30 and 45	10/20/2016
Ropinirole HCl	Tablet			Refer to USP			05/15/2014
Ropinirole HCl	Tablet (Extended Release)	II (Paddle)	100	pH 4.0 Citrate-THAM Buffer	500	1, 2, 4, 6, 8, 12, 16, 20 and 24 hours	08/27/2009
Rosuvastatin Calcium	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Rotigotine	Transdermal	Paddle over Disk (Apparatus 5)	50	Phosphate Buffer, pH 4.5 at 32°C	900	15, 30, 60, 90, 120, 150 and 180	07/15/2009
Rucaparib	Tablet	II (Paddle)	75	0.01 N HCl	900	5, 10, 15, 20 and 30	01/19/2017
Rufinamide	Tablet			Refer to USP			08/15/2013
Rufinamide	Suspension			Develop a dissolution method			09/15/2023
Ruxolitinib Phosphate	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Sacubitril/Valsartan	Tablet	I (Basket)	75	Phosphate Buffer, pH 6.8[degassed]	900	10, 15, 20, 30 and 45	10/24/2019
Safinamide Mesylate	Tablet	II (Paddle)	100	0.1 N HCL with Sodium Chloride [0.2% (wt/vol) solution], pH 1.2	900	5, 10, 15, 30, 45 and 60	10/06/2023
Sapropterin Dihydrochloride	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Saquinavir Mesylate	Tablet	II (Paddle)	50	Citrate Buffer (pH 3.0)	900	10, 20 , 30 and 45	09/13/2007
Saquinavir Mesylate	Capsule			Refer to USP			09/13/2007
Saxagliptin HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Scopolamine	Transdermal	Reciprocating disk (Apparatus 7)	Stroke depth: 2-3 cm; 30-60 cycles per minute	Distilled Water	25 × 150 mm test-tubes containing 20 mL	1, 2, 4, 6, 12, 18, 24, 36, 48, and 72 hours	07/15/2009
Secnidazole	Granule	I (Basket)	50	Phosphate Buffer, pH 6.8	900	0.5, 1, 1.5, 2, 2.5, 3, 3.5 and 4 hours	11/16/2017
Selegiline HCl	Capsule			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Selegiline (20 mg/20 cm2 and 30 mg/30 cm2)	Transdermal	Paddle over Disk (Apparatus 5)	50	0.1 M Phosphate buffer, monobasic, pH 5 at 32°C	500	1, 2, 4, 8, 12, 16, 20 and 24 hours	07/15/2009
Selegiline (40 mg/40 cm2)	Transdermal	Rotating Cylinder (Apparatus 6)	50	0.1 M Phosphate buffer, monobasic, pH 5 at 32°C	1000	1, 2, 4, 8, 12, 16, 20 and 24 hours	07/15/2009
Selegiline HCl	Tablet (Orally Disintegrating)			Develop a dissolution method			09/15/2023
Selexipag	Tablet	II (Paddle)	50	Phosphate Buffer, pH 6.8	900	5, 10, 15, 20 and 30	03/17/2016
Selinexor	Tablet	II (Paddle)	75	10 mM Citric Acid Buffer, pH 4.5 with 0.5% SDS	900	10, 15, 20, 30 and 45	08/19/2021
Selpercatinib	Capsule	II (Paddle)	75	0.1N HCl	900	5, 10, 15, 20 and 30	07/07/2022
Selumetinib	Capsule	II (Paddle) with sinker	75	Sodium Phosphate Buffer, pH 6.5, with 0.5% Polysorbate 80	1000	10, 20, 30, 45 and 60	07/07/2022
Semaglutide	Tablet	II (Paddle)	70	50 mM Phosphate Buffer with 0.05% Brij 35 (polyoxyethylene lauryl ether), pH 6.8	500	10, 15, 20, 30, 45, 60 and 75	08/19/2021
Sertraline HCl	Tablet	II (Paddle)	75	0.05 M Sodium Acetate Buffer, pH 4.5	900	10, 20, 30 and 45	02/20/2004
Sertraline HCl	Capsule	II (Paddle) with sinker	75	0.1 N HCl	900	10, 15, 20, 30 and 45	07/07/2023
Sevelamer Carbonate	Tablet			Disintegration Testing in 0.1 N HCl as per USP <701>			10/06/2008
Sevelamer HCl	Capsule			Disintegration Testing in 0.1 N HCl as per USP <701>			04/09/2008
Sevelamer HCl	Tablet			Disintegration Testing in 0.1 N HCl as per USP <701>			04/09/2008
Sibutramine HCl	Capsule	II (Paddle)	50	0.05 M Acetate Buffer, pH 4.0	500	10, 20, 30, 45 and 60	02/25/2004
Sildenafil Citrate	Tablet	I (Basket)	100	0.01 N HCl	900	5, 10, 15 and 30	03/04/2006
Sildenafil Citrate	Suspension	II (Paddle)	50	McIlvaine Buffer, pH 5.0	500	5, 10, 15, 20 and 30	05/28/2015
Silodosin	Capsule			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Simeprevir Sodium	Capsule	II (Paddle)	75	0.05 M Phosphate Buffer, pH 6.8 with 1.0% polysorbate 20	900	10, 15, 20, 30 and 45	05/28/2015
Simvastatin	Suspension	II (Paddle)	50	Phosphate Buffer, pH 7.0, with 0.14% sodium dodecyl sulfate (SDS)	900	10, 15, 20, 30 and 45	12/22/2016
Simvastatin	Tablet			Refer to USP			06/18/2007
Simvastatin	Tablet (Orally Disintegrating)	II (Paddle)	75	0.15% SDS Buffer, pH 6.8	900	5, 10, 15 and 30	09/03/2008
Siponimod Fumaric Acid	Tablet	II (Paddle)	50	Phosphate Buffer, pH 6.8 with 0.1% (m/v) Polysorbate 80	900 mL [for 2 mg strength] 500 mL [for 0.25 mg strength]	5, 10, 15, 20 and 30	08/19/2021
Sirolimus	Tablet			Develop a dissolution method			09/15/2023
Sirolimus	Gel			Develop a method to characterize in vitro release			05/18/2023
Sitagliptin Phosphate	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Sitagliptin Phosphate/Simvastatin	Tablet	II (Paddle) with stainless steel stationary quadrangular hanging basket	100	10 mM Sodium phosphate buffer containing 1% Tween 80 with 50 μg/mL Butylated hydroxyanisole	900	5, 10, 15, 20, 30, and 45	10/31/2013
Sodium Iodide I-123	Capsule			Develop a dissolution method			09/15/2023
Sodium Iodide I-131	Capsule			Develop a dissolution method			07/07/2022
Sodium Oxybate	For Suspension (Extended Release)	II (Paddle)	100	Stage 1: 0.1N HCl for 2h; Stage 2: pH 6.0 Phosphate Buffer for 6h	900	0.25, 1, 2, 2.5, 3, 3.5, 4 and 5 hours	05/31/2024
Sodium Phenylbutyrate	Pellets	II (Paddle)	75	Simulated Intestinal Fluid without pancreatin	900	5, 10, 15, 30 and 45	02/05/2024
Sodium Phenylbutyrate	Powder for Oral	II (Paddle)	75	Simulated Intestinal Fluid	900	15, 30, 45, 60 and 90	04/02/2009
Sodium Phenylbutyrate; Taurursodiol	Powder	II (Paddle)	75	5 mM phosphate w/ 0.1% SDS, pH 6.8	900	5, 10, 15, 30 and 45	02/05/2024
Sodium Phosphate Dibasic Anhydrous/Sodium Phosphate Monobasic Monohydrate	Tablet			Develop a dissolution method			09/15/2023
Sofosbuvir	Pellets	II (Paddle)	75	25 mM Potassium Phosphate Buffer, pH 5.5	900	5, 10, 15, 20, 30 and 45	08/19/2021
Sofosbuvir	Tablet	II (Paddle)	75	0.05 M Phosphate Buffer, pH 6.8	900	5, 10, 15, 20 and 30	08/19/2021
Sofosbuvir/Velpatasvir	Tablet	II (Paddle)	75	50 mM sodium acetate buffer,pH 5.0, with 0.5% w/v Cetyltrimethyl ammonium bromide (CTAB)	900	5, 10, 15, 20 and 30	10/20/2016
Solifenacin Succinate	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Solifenacin Succinate	Suspension	II (Paddle)	50	0.1 N HCl	900	5, 10, 15, 20 and 30	07/07/2022
Solriamfetol HCl	Tablet	I (Basket)	100	0.1 N HCl	900	5, 10, 15, 20 and 30	08/19/2021
Sonidegib Phosphate	Capsule	II (Paddle) with sinker	75	Tier 1: 0.1 M HCl with 1.0% SDS; Tier II: Stage 1: 850 mL of 0.1 N HCl solution with pepsin [250’000 units/L]. Stage 2: After 10 minutes add 50 mL of 18% SDS in 0.1 N HCl	Tier 1: 900; Tier 2: Stage 1: 850 mL, Stage 2: 900 mL	15, 30, 45, 60, and 90	03/17/2016
Sorafenib Tosylate	Tablet	II (Paddle)	75	0.1 M HCl with 1% SDS	900	5, 10, 15, 20 and 30	06/10/2009
Sotagliflozin	Tablet			Develop a dissolution method			08/05/2024
Sotorasib	Tablet	II (Paddle)	75	120 mg: 50 mM phosphate buffer, pH 6.8 with 0.2% SLS; 320 mg: 50 mM phosphate buffer, pH 6.8 with 0.4% SDS	900	5,10,15, 20 and 30	11/30/2023
Sparsentan	Tablet	II (Paddle)	60	0.1 N HCl	1000	5, 10, 15, 20, 30, 45 and 60	05/31/2024
Spironolactone	Tablet			Refer to USP			04/15/2008
Stavudine	Capsule			Develop a dissolution method			01/03/2024
Succimer	Capsule	II (Paddle)	50	0.01 N Phosphoric Acid	900	10, 20, 30, 45, 60 and 90	02/20/2004
Sucralfate	Suspension	II (Paddle)	75	0.1N HCl/0.067 M KCl, pH 1.0	900	10, 20, 30 and 45	03/04/2006
Sucralfate	Tablet	II (Paddle)	75	0.1 N HCl/0.067 M KCl, pH 1.0	900	15, 30, 45, 60, 180, 240 and 480	04/02/2009
Sucroferric Oxyhydroxide	Tablet (Chewable)	II (Paddle)	50	0.1 N HCl	900	10, 15, 20, 30, 45 and 60	11/02/2017
Sufentanil Citrate	Tablet (Sublingual)	II (Paddle)	50	pH 4.5 Acetate Buffer	50	2, 4, 8, 12 and 15	05/12/2022
Sulfadiazine	Tablet			Refer to USP			07/14/2008
Sulfamethoxazole/Trimethoprim	Tablet			Refer to USP			01/14/2008
Sulfamethoxazole/Trimethoprim	Suspension	II (Paddle)	50	1 mL of 0.2 N HCl in water	900	10, 20, 30, 45, 60 and 90	02/25/2004
Sulfasalazine	Tablet			Refer to USP			12/15/2009
Sulfasalazine	Tablet (Delayed Release)			Refer to USP			12/15/2009
Sulfisoxazole Acetyl	Oral Suspension (Pediatric)	II (Paddle)	30	1% SLS in 0.1N HCl	900	15, 30, 45, 60 and 90	08/17/2006
Sumatriptan Succinate	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Sunitinib Malate	Capsule			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Suvorexant	Tablet			Develop a dissolution method			09/15/2023
Tacrolimus	For Suspension	II (Paddle)	50	Hydroxypropyl Cellulose Solution (1 in 20,000). Adjust to pH 4.5 by Phosphoric Acid		15, 30, 45, 60, 90 and 120	02/09/2023
Tacrolimus	Capsule	II (Paddle)	50	Hydroxypropyl Cellulose Solution (1 in 20,000). Adjust to pH 4.5 by Phosphoric Acid	900	30, 60, 90 and 120	02/20/2004
Tacrolimus	Tablet (Extended Release)	II (Paddle)	100	0.005% HPC in Water with 0.50% SLS adjusted to pH 4.5	900	0.5, 1, 2.5, 4.5, 6.5, 8.5 and 12 hours	06/30/2016
Tadalafil	Tablet	II (Paddle)	50	0.5% Sodium Lauryl Sulfate	1000	10, 20, 30 and 45	01/26/2006
Tafamidis	Capsule	II (Paddle) with sinker	75	Tier 1 Medium: 0.05M Sodium Phosphate Buffer, pH 6.8 with 1.0% Tween 80; Tier II Medium: 0.05M Sodium Phosphate Buffer, pH 6.8 with 1.0% Tween 80 and enzyme with protease activity as per USP	900	5, 10, 15, 20, 30 and 45	04/22/2021
Tafamidis Meglumine	Capsule	II (Paddle) with sinker	75	Tier 1 Medium: 0.05M Sodium Phosphate Buffer, pH 6.8. Tier 2 Medium: 0.05M Sodium Phosphate Buffer, pH 6.8, and pancreatin with protease activity as per USP	900	5, 10, 15, 20, 30 and 45	04/22/2021
Tafenoquine Succinate	Tablet	II (Paddle)	75	0.01M Sodium phosphate buffer, pH 6.8, with 0.20% w/v of Polysorbate 20	900	5, 10, 20, 30, 45 and 60	08/27/2020
Talazoparib Tosylate	Capsule	II (Paddle) with sinker	75	0.01 N HCl with 0.2% sodium dodecyl sulfate (SDS),	500	10, 15, 20, 30 and 45	08/27/2020
Tamoxifen Citrate	Tablet			Refer to USP			04/02/2009
Tamsulosin HCl	Capsule	II (Paddle)	100	0-2 hours: 0.003% polysorbate 80, pH 1.2 2-8 hours: phosphate buffer, pH 7.2	500	1, 2, 3, 6, 8, and 10 hours	03/26/2007
Tapentadol HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Tapentadol HCl	Tablet (Extended Release)	II (Paddle) with sinker	100	0.05 M Phosphate Buffer of pH 6.8, Simulated intestinal fluid (without enzyme)	900	0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours	10/31/2013
Tasimelteon	Capsule			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Tasimelteon	Suspension			Refer to FDA's Dissolution Guidance, 2018			05/31/2024
Tazemetostat Hydrobromide	Tablet	II (Paddle)	50	0.01 N HCl	900	5, 10, 15, 20, 30 and 45	05/12/2022
Tedizolid Phosphate	Tablet	II (Paddle)	60	0.05 M phosphate buffer pH 6.8	900	5, 10, 15, 20 and 30	06/02/2016
Tegaserod Maleate	Tablet			Develop a dissolution method			09/15/2023
Telaprevir	Tablet			Develop a dissolution method			09/15/2023
Telbivudine	Tablet	II (Paddle)	50	0.1 N HCl	900	15, 30 and 45	04/02/2009
Telithromycin	Tablet	II (Paddle)	50	0.1 N HCl	900	10, 20, 30 and 45	01/03/2007
Telmisartan	Tablet			Refer to USP			01/05/2012
Temazepam	Capsule			Refer to USP			01/14/2008
Temozolomide	Capsule			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Tenapanor Hydrochloride	Tablet	II (Paddle)	75	9.4 mM Citrate Buffer, pH 4	900	5, 10, 15, 20, 30 and 45	08/19/2021
Tenofovir Alafenamide Fumarate	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Tenofovir Disoproxil Fumarate	Powder for Oral	II (Paddle)	100	0.2% polysorbate 80 in 0.01 M HCl	900	10, 20, 30, 45, 60 and 75	01/31/2013
Tenofovir Disoproxil Fumarate	Tablet	II (Paddle)	50	0.1 N HCl	900	10, 20, 30, and 45	01/03/2007
Tepotinib HCl	Tablet	II (Paddle)	50	Acetate buffer, pH 4.5 + 1 mM NaCl + 0.1% polysorbate 80	900	5, 15, 20 and 35	03/30/2023
Terazosin HCl	Tablet			Develop a dissolution method			09/15/2023
Terazosin HCl	Capsule			Develop a dissolution method			09/15/2023
Terbinafine HCl	Tablet	II (Paddle)	50	Citrate Buffer, pH 3.0 adjusted with HCl	500	10, 20, 30 and 45	02/20/2004
Terconazole	Suppository (Vaginal)	I (with Palmieri type basket)	100	0.12 N HCl with 1% SLS	900	15, 30, 45, 60, 90, 120 and 150	10/08/2009
Teriflunomide	Tablet	II (Paddle)	50	0.05 M Phosphate Buffer, pH 6.8	1000	5, 10, 15, 20, 30 and 45	05/15/2014
Testosterone	Film, Transdermal (Extended Release)	V (Paddle over disk). Paddle 25 mm above the film on the disk.	50	0.1 M sodium chloride containing 2.5% (v/v) of Tween 40 at 32 ± 0.5°C. Delivery surface faces upwards towards the media.	900	1, 3, 5, 7, 11, 16, 20 and 24 hours	06/30/2011
Testosterone	Buccal Tablet (Extended Release)			Develop a dissolution method			09/15/2023
Testosterone	Pellet Implant			Develop a dissolution method			11/25/2008
Testosterone Undecanoate	Capsule	II (Paddle)	75	0.01 N HCl with 0.5% Triton X 100	900	5, 10, 15, 30, 45 and 60	02/05/2024
Testosterone Undecanoate	Capsule	II (Paddle)	75	Phosphate buffer pH 6.8 with 1.0% Triton X-100	900	10, 15, 20, 30 and 45	08/19/2021
Tetrabenazine	Tablet	II (Paddle)	50	0.1 N HCl	900	5, 10, 15, 30 and 45	09/01/2011
Tetracycline HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Tetracycline HCl	Capsule			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Thalidomide	Capsule	II (Paddle)	100	1.5% (w/v) SLS (pH 3.0, adj w/ HCl)	900	10, 20, 30, 60 and 90	03/04/2006
Theophylline	Capsule (Extended Release)			Refer to USP	900		10/06/2008
Theophylline (100 mg and 200 mg)	Tablet (Extended Release)	II (Paddle)	50	SGF without Enzyme, pH 1.2 during 1st hour. Phosphate Buffer at pH 7.5 from end of hour 1 through the duration of testing	900	1, 4, 8, 12 hours	10/06/2008
Theophylline (300 mg and 450 mg)	Tablet (Extended Release)	II (Paddle)	50	SGF without Enzyme, pH 1.2 during 1st hour. Phosphate Buffer at pH 7.5 from end of hour 1 through the duration of testing	900	1, 4, 8, 12 hours	10/06/2008
Theophylline (600 mg and 400 mg)	Tablet (Extended Release)	I (Basket)	100	SGF without enzyme, pH 1.2 during 1st hour. SIF without enzyme from end of hour 1 through the duration of the testing	900	1, 2, 4, 8, 12 and 24 hours	10/06/2008
Thioguanine	Tablet			Develop a dissolution method			01/03/2024
Tiagabine HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Ticagrelor	Tablet			Develop a dissolution method			09/15/2023
Ticlopidine HCl	Tablet			Develop a dissolution method			09/15/2023
Timolol Maleate	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Tinidazole	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Tiopronin	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Tiopronin	Tablet (Delayed Release)	I (Basket)	100	Acid Stage: 0.1 N HCl; Buffer Stage: 50 mM Potassium phosphate, pH 6.8	Acid Stage: 900; Buffer Stage: 900	Acid Stage:120; Buffer Stage:10, 20, 30, 45 and 60	07/07/2022
Tipiracil HCl/Trifluridine	Tablet	II (Paddle)	50	0.1 N HCl	900	5, 10, 15, 20 and 30	11/02/2017
Tipranavir	Capsule	II (Paddle)	50	0.05 M phosphate buffer pH 6.8	900	15, 30, 45 and 60	12/03/2007
Tivozanib HCl	Capsule	II (Paddle with sinker)	50	Tier I: 0.1 mM HCI with 0.5% (w/v) sodium dodecyl sulfate (SDS) (900 mL); Tier II: 0.1 mM HCI with pepsin (as per USP) (750 mL) for the first 10 minutes, followed by addition of 0.1 mM HCI with SDS (3% w/v) (150 mL) for the remainder of the dissolution	900	5, 10, 15, 20 and 30	02/09/2023
Tizanidine HCl	Capsule			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Tizanidine HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Tofacitinib Citrate	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Tofacitinib Citrate	Tablet (Extended Release)	II (Paddle) with option to use a sinker	50	Phosphate Buffer, pH 6.8	900	1, 1.5, 2, 2.5, 3, 4, 6 and 8 hours	07/28/2016
Tolcapone	Tablet			Refer to USP			05/09/2013
Tolterodine Tartrate	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Tolterodine Tartrate	Capsule (Extended Release)	I (Basket)	100	Phosphate buffer (pH 6.8)	900	1, 3, 7 hours	06/18/2007
Tolvaptan	Tablet			Develop a dissolution method			09/15/2023
Topiramate	Capsule (Sprinkle)			Develop a dissolution method			09/15/2023
Topiramate	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Topiramate [25, 50, 100, 150 mg and 200 mg]	Capsule (Extended Release)	I (Basket)	100	50 mM Tris buffer, pH 7.2	900	0.5, 1, 2, 4, 6 and 8 hours	06/25/2015
Topiramate [25, 50, 100 and 200 mg]	Capsule (Extended Release)	II (Paddle)	50	0.05 M Phosphate Buffer, pH 7.5	750	1, 2, 3, 4, 6 and 8 hours	08/14/2014
Topotecan HCl	Capsule	II (Paddle)	50	Acetate Buffer with 0.15% SDS, pH 4.5	500	5, 10, 20, 30 and 45	04/27/2009
Toremifene Citrate	Tablet	II (Paddle)	50	0.02 N HCl	1000	10, 20, 30 and 45	02/20/2004
Torsemide	Tablet	II (Paddle)	50	0.1 N HCl	900	5, 10, 15 and 30	02/20/2004
Torsemide [20, 40 and 60 mg]	Tablet	II (Paddle)	75	0.1 N HCl	900	1, 2, 3, 4, 6, 8 and 10 hours	07/07/2022
Tramadol	Capsule (Extended Release)			Develop a dissolution method			09/15/2023
Tramadol HCl	Tablet (Extended Release)	I (Basket)	75	0.1 N HCl	900	2, 4, 8, 10 and 16 hours	01/03/2007
Tramadol HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Trametinib Dimethyl Sulfoxide	Tablet	II (Paddle)	60	pH 4.5, 50 mM Sodium Acetate with 0.75% Sodium Lauryl Sulfate [SLS]	500	5, 10, 15, 20 and 30	12/24/2015
Trandolapril	Tablet			Develop a dissolution method			09/15/2023
Trandolapril/Verapamil HCl	Tablet (Extended Release)	II (Paddle)	50	Trandolapril: Develop a dissolution method; Verapamil: 0-1 hour Gastric Fluid w/o Pepsin pH=1.2, 1-8 hour Intestinal Fluid w/o Pancreatin	Verapamil: 900	Verapamil: 1, 2, 3.5, 5 and 8 hours	09/15/2023
Tranexamic Acid	Tablet			Develop a dissolution method			09/15/2023
Tranylcypromine Sulfate	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Trazodone HCl	Tablet			Refer to USP			05/18/2023
Trazodone HCl	Tablet (Extended Release)			Develop a dissolution method			09/15/2023
Treprostinil Diolamine	Tablet (Extended Release)	I (Basket)	100	0.05 M Phosphate Buffer, pH 6.8 (deaerated)	500	1, 2, 4, 6, 8, 12, 16, 20 and 24 hours	06/02/2016
Tretinoin	Capsule	I (Basket)	100	0.5% solid Lauryldimethylamine-oxide (LDAO) in 0.05M Phosphate Buffer, pH 7.8	900	10, 15, 20, 30 and 45	08/05/2010
Triamcinolone Acetonide	Injectable Suspension			Develop a dissolution method using USP IV (Flow-Through Cell), and, if applicable, Apparatus II (Paddle) or any other appropriate method, for comparative evaluation by the Agency			01/15/2010
Triamcinolone Acetonide	Intra-Articular, For Suspension (Extended Release)	II (Paddle)	75	0.3% SDS in 10 mM phosphate buffer, pH 7.2 + 0.02% sodium azide @35°C	1000	1, 2, 4, 8, 12, 16, 24, 36, 48, 72, 96 and 120 hours	02/08/2018
Triclabendazole	Tablet	II (Paddle)	75	0.1N HCl with 1% Tween 20	1000	5, 10, 15, 20 and 30	08/27/2020
Trientine HCl	Capsule			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Trimethoprim	Tablet			Refer to USP			01/29/2010
Trimipramine Maleate	Capsule			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Triptorelin Pamoate	For Intramuscular Suspension (Extended Release)	II (Paddle)	75	50 mL of methanol to 950 mL of water	950	1, 8, 24, 96, and 168 hours	11/16/2017
Triptorelin Pamoate	Injectable Suspension	II (Paddle)	200	Water-Methanol (95:5); Reconstitute vial in 2 mL Water for Injection, add to 500 mL medium at 37°C	500	1, 6, 12, 24, 48 and 72 hours	07/14/2008
Trospium Chloride	Capsule (Extended Release)	II (Paddle) with sinker	50	0.1 N HCl, pH 1.1 for 2 hrs and then add 200 mL of 0.1 N NaOH in 200 mM Phosphate Buffer. Adjust pH to 7.5 using 2 N HCl and/or 2N NaOH	0-2 hrs: 750 ml, After 2 hrs: 950 ml.	2, 3, 4, 6, 8, 12 and 16 hours	07/15/2010
Trospium Chloride	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Tucatinib	Tablet	II (Paddle)	75	0.1 M Citrate Buffer, pH 3.4, containing 0.05% Brij 35 (polyoxyethylene lauryl ether)	900	10, 15, 20, 30 and 45	05/12/2022
Ulipristal Acetate	Tablet	II (Paddle)	50	0.1 N HCl	900	5, 10, 15, 20 and 30	01/31/2013
Upadacitinib	Tablet (Extended Release)	I (Basket)	100	50 mM Phosphate buffer, pH 6.8 [for 15 mg and 30 mg strengths]; 25 mM Phosphate buffer with 2.75% NaCl, pH 6.8 for [45 mg strength]	900	1, 2, 4, 6, 8, 12 and 16 hours	02/09/2023
Uridine Triacetate	Granule	II (Paddle)	60	50 mM Phosphate Buffer, pH 6.8	900	10, 15, 20, 30, 45 and 60	07/07/2022
Ursodiol	Capsules			Refer to USP			07/21/2009
Ursodiol	Tablet			Refer to USP			04/15/2008
Valacyclovir Hydrochloride	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Valbenazine	Capsule	II (Paddle) with sinker	50	Tier 1: 0.1N HCl; Tier 2: 0.1N HCl containing pepsin (750,000 units per 1000 mL)	900	5, 10, 15, 20 and 30	11/02/2017
Valganciclovir HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Valproic Acid	Capsule			Refer to USP			12/15/2009
Valsartan	Tablet			Refer to USP			07/28/2016
Valsartan	Capsule	II (Paddle)	50	0.067 M Phosphate Buffer, pH 6.8	1000	10, 20, 30 and 45	12/13/2004
Vancomycin hydrochloride	Capsule			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Vandetanib	Tablet	II (Paddle)	50	pH 1.2 Buffer [0.05 M KCl in water, adjust the pH with HCl or NaOH]	1000	5, 10, 15, 20 and 30	06/25/2015
Vardenafil HCl	Tablet (Orally Disintegrating)	II (Paddle)	50	0.1 N HCl	900	5, 10, 15 and 30	05/15/2014
Vardenafil HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Varenicline Tartrate	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Vemurafenib	Tablet	II (Paddle)	75	1% hexadecyltrimethylammonium bromide (HTAB) in 0.05 M Phosphate Buffer, pH 6.8	900	10, 15, 20, 30 and 45	05/28/2015
Venetoclax	Tablet	III (Reciprocating Cylinder) [Bottom Screen: 200 mesh stainless steel]	20 dpm	Phosphate Buffer, pH 6.8 with 0.4% sodium dodecyl sulfate (SDS) [3 small drops of antifoaming agent may be used]	250	0.25, 0.5, 0.75, 1, 1.5, 2, 3, 3.5 and 4 hours	07/28/2016
Venlafaxine Besylate	Tablet (Extended Release)	II (Paddle with sinker)	50	0.1 M NaCl in water (Degassed)	900	1, 2, 4, 6, 8, 12, 14 and 16 hours	02/09/2023
Venlafaxine HCl	Capsule (Extended Release)			Develop a dissolution method			09/15/2023
Venlafaxine HCl	Tablet (Extended Release)			Develop a dissolution method			09/15/2023
Venlafaxine HCl	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Verapamil HCl	Tablet (Extended Release)			Refer to USP			06/24/2010
Verapamil HCl	Capsule (Extended Release)			Refer to USP			08/27/2015
Verapamil HCl	Tablet			Refer to USP			11/04/2008
Vericiguat	Tablet	II (Paddle)	75	0.01 N HCl, pH 2.0	900	5, 10, 15, 20 and 30	07/07/2022
Verteporfin	Injectable			Develop a method to characterize in vitro release.			08/14/2014
Vibegron	Tablet			Refer to FDA's Dissolution Guidance, 2018			02/09/2023
Vigabatrin	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Vilazodone HCl	Tablet	II (Paddle)	60	0.1% v/v Glacial acetic acid solution (pH 3.1)	1000	10, 15, 20, 30 and 45	08/14/2014
Viloxazine HCl	Capsule (Extended Release)	II (Paddle) with sinker	50	pH 6.8 Phosphate Buffer	900	1, 2, 4, 6, 8, 10, 12 and 16 hours	07/07/2022
Vismodegib	Capsule	II (Paddle)	75	0.01 N HCl with 1.0% sodium lauryl sulfate (SLS)	900	10, 15, 20, 30 and 45	05/28/2015
Voclosporin	Capsule	II (Paddle)	75	0.75% of Polyoxyl 40 hydrogenated castor oil in sodium acetate buffer (22mM), pH 4.5	900	10, 20, 30, 45 and 60	02/09/2023
Vorapaxar Sulfate	Tablet	II (Paddle)	50	41 mM Na2HPO4, 1.5% Citric Acid, pH 3.0 ± 0.5	900	5, 10, 20, 30, 45 and 60	12/24/2015
Voriconazole	Suspension	II (Paddle)	50	0.1 N HCl	900	10, 20, 30 and 45	01/03/2007
Voriconazole	Tablet	II (Paddle)	50	0.1 N HCl	900	10, 20, 30 and 45	11/25/2008
Vorinostat	Capsule			Develop a dissolution method			09/15/2023
Vortioxetine HBr	Tablet	II (Paddle)	50	0.1 N HCl	900	10, 15, 20, 30 and 45	05/28/2015
Voxelotor	Tablet	II (Paddle)	75	50 mM phosphate buffer (pH 6.8) with 2% sodium lauryl sulfate (SLS)	900	5, 10, 20, 30 and 45	07/28/2022
Voxelotor	Tablet, for Suspension	II (Paddle)	75	50 mM phosphate buffer (pH 6.8) with 2% sodium lauryl sulfate (SLS)	900	5, 10, 15, 20 and 30	07/28/2022
Warfarin Sodium	Tablet			Develop a dissolution method			01/03/2024
Zafirlukast	Tablet	II (Paddle)	50	1% w/v Aqueous Sodium Dodecyl Sulfate	1000	10. 30, 30 and 45	10/09/2007
Zalcitabine	Tablet			Develop a dissolution method			01/03/2024
Zaleplon	Capsule			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Zidovudine	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Zileuton	Tablet			Develop a dissolution method			09/15/2023
Zileuton	Tablet (Extended Release)			Develop a dissolution method			09/15/2023
Zinc Acetate	Capsule	II (Paddle)	50	0.1 N HCl	900	10, 20, 30 and 45	02/19/2004
Ziprasidone HCl	Capsule	II (Paddle)	75	Tier I: 0.05 M Na phosphate buffer, pH 7.5 + 2% SDS (w/w) Tier II: 0.05 M Na phosphate buffer, pH 7.5 (700ml) + 1% pancreatin. After 15 min. incubation, add 200 mL of phosphate buffer containg 9% SDS	900	10, 20, 30, 45 and 60	03/04/2006
Zolmitriptan	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Zolmitriptan	Tablet (Orally Disintegrating)	II (Paddle)	50	0.1 N HCl	500	5, 10, 15, 20 and 30	06/18/2007
Zolpidem Tartrate	Tablet			Refer to FDA's Dissolution Guidance, 2018			07/02/2020
Zolpidem Tartrate	Tablet (Extended Release)			Refer to USP			01/05/2012
Zolpidem Tartrate (1.75 and 3.5 mg)	Tablet (Sublingual)	II (Paddle)	50	Simulated intestinal fluid (without enzyme), pH 6.8, (deaerated)	500	1, 3, 5, 7, 10 and 15	08/14/2014
Zolpidem Tartrate (5 and 10 mg)	Tablet (Sublingual)	II (Paddle)	75	Phosphate Buffer, pH 6.8	900	1, 3, 5, 7, 10 and 15	08/14/2014
Zonisamide	Capsule			Develop a dissolution method			09/15/2023

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