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 II (Paddle) 75 0.1 N HCl 900 5, 10, 15, and 30 03/22/2006
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/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 900 5, 10, 15, 30 and 45 01/03/2007
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
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) 1000 120 (Acid) 30, 60, 90, 120, and 180 (buffer) 12/20/2005
Acarbose Tablet II (Paddle) 75 Water (deaerated) 900 10, 15, 20, 30 and 45 03/22/2006
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 Refer to USP 06/25/2015
Acetaminophen/Butalbital Tablet II (Paddle) 50 Water (deaerated) 900 15, 30, 45, 60 and 90 01/03/2007
Acetaminophen/Butalbital/Caffeine Tablet Refer to USP 01/14/2008
Acetaminophen/Butalbital/Caffeine/Codeine Phosphate Capsule  II (Paddle)  50 Water (deaerated) 1000 10, 20, 30, 45 and 60  05/15/2014
Acetaminophen/Caffeine/Dihydrocodeine Bitartrate Tablet II (Paddle) 50 Water 900 10, 15, 30, 45 and 60 07/25/2007
Acetaminophen/Caffeine/Dihydrocodeine Bitartrate Capsule I (Basket) 100 Water 900 10, 20, 30, 45 and 60 01/03/2007
Acetaminophen/Hydrocodone Bitartrate Tablet Refer to USP (provide individual unit data). 08/15/2013
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 I (Basket) 100 Water (deaerated) 900 10, 20, 30, 45 and 60 01/12/2004
Acetaminophen/Propoxyphene HCl Tablet Refer to USP 01/15/2010
Acetaminophen/Propoxyphene Napsylate Tablet Refer to USP 01/15/2010
Acetaminophen/Tramadol HCl Tablet II (Paddle) 50 0.1 N HCl 900 5, 10, 15, 20 and 30 03/04/2006
Acetazolamide Tablet  Refer to USP   07/21/2011
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 Refer to USP 07/14/2008
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 Capsule Refer to USP  01/05/2012
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 Tablet Refer to USP 06/18/2007
Adefovir Dipivoxil Tablet II (Paddle) 50 0.01 N HCl 600 10, 20, 30, 45 and 60 04/10/2008
Afatinib Dimaleate Tablet II (Paddle) 75 McIlvaine Buffer pH 4.0 900 5, 10, 15, 20 and 30 05/28/2015
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 Refer to USP 09/03/2008
Albuterol Sulfate Tablet (Extended Release) II (Paddle) 50 0.1 N HCl 900 1, 2, 4, 6, 9 and 12 hours 04/09/2007
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 USP 01/14/2008
Alendronate Sodium/Cholecalciferol Tablet II (Paddle) For Alendronate: 50; For Cholecalciferol: 75 For Alendronate: Deaerated Water; For Cholecalciferol: 0.3% SDS in USP Water For Alendronate: 900; For Cholecalciferol: 500 10, 15, 20, 30 and 45 11/25/2008
Alfuzosin HCl Tablet (Extended Release) II (Paddle) 100 0.01 N HCl 900 1, 2, 12, 20 hours 06/18/2007
Aliskiren Hemifumarate Tablet I (Basket) 100 0.01 N HCl 500 10, 20, 30 and 45 09/03/2008
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 II (Paddle) 50 0.1 N HCl 900 5, 10, 15, and 30 01/20/2006
Alogliptin Benzoate Tablet II (Paddle)  50 0.01 N HCl 900 5, 10, 15, 20 and 30 02/14/2014
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 II (Paddle) 50 (for 1 mg) & 75 (for 0.5 mg) Water (deaerated) 500 10, 20, 30 and 45 01/26/2006
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 Refer to USP 06/18/2007
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
Alvimopan Capsule II (Paddle 50 0.1 N HCl 900 5, 10, 15, 20, 30 and 45  10/21/2010
Amantadine HCl Tablet II (Paddle) 50 Water (deaerated) 500 10, 20, 30, 45 and 60 01/12/2004
Amantadine HCl Capsule Refer to USP  12/23/2010
Ambrisentan Tablet II (Paddle) 75 0.05 M Acetate Buffer, pH 5.0 900 5, 10, 15, 30, and 45 05/20/2009
Amiloride HCl Tablet Refer to USP 06/07/2012
Amiloride HCl/Hydrochlorothiazide Tablet Refer to USP 06/07/2012
Aminocaproic Acid Tablet Refer to USP 08/27/2015
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 II (Paddle) 100 1% SLS in water 1000 10, 20, 30, 45, 60 and 90 01/12/2004
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 II (Paddle) 75 0.01 N HCl 500 10, 20, 30, 45 and 60 01/14/2004
Amlodipine Besylate Tablet (Orally Disintegrating) II (Paddle) 50 0.01 N HCl 500 5, 10, 15 and 20 10/06/2008
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 For Oral Suspension  II (Paddle) 50 Water (degassed) 900 5, 10, 15, 20, 30 and 45 06/06/2013
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 USP 01/31/2013
Amoxicillin Tablet Refer to USP 01/31/2013
Amoxicillin/Clarithromycin/Lansoprazole Capsule/Tablet/Capsule (Copackage) Refer to USP for monographs of Amoxicillin Capsules, Clarithromycin Tablets and Lansoprazole Delayed-Release Capsules 02/28/2013
Amoxicillin/Clarithromycin/Omeprazole Capsule/Tablet/Capsule (Copackage) Refer to USP for monographs of Amoxicillin Capsules, Clarithromycin Tablets and Omeprazole Delayed-Release Capsules 02/28/2013
Amoxicillin/Clavulanate Potassium Tablet  Refer to USP As appropriate 0, 0.5, 1, 2, 3, 4 and 5 hours 10/04/2012
Amoxicillin/Clavulanate Potassium Tablet (Chewable) Refer to USP 01/14/2008
Amoxicillin/Clavulanate Potassium Suspension II (Paddle) 75 Water (deaerated) 900 5, 10, 15 and 30 01/14/2004
Amphetamine Suspension (Extended Release)   Develop a dissolution method 12/22/2016
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 Aspartate/Amphetamine Sulfate/Dextroamphetamine Saccharate/Dextroamphetamine Sulfate Tablet I (Basket) 100 Deionized Water 500 10, 20, 30 and 45 11/25/2008
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 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
Amphotericin B Injectable (Liposomal)   Develop a method to characterize in vitro release 07/28/2016
Ampicillin/Ampicillin Trihydrate for Oral Suspension II (Paddle) 25 Water (deaerated) 900 5, 10, 15, 20 01/03/2007
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 II (Paddle) 50 Water 900 5, 10, 15, and 30 and 45 01/03/2007
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
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 For Oral Suspension   II (Paddle) 50 Water (with 1.2% Tween 80) 900 5, 10, 15 and 20 03/17/2016
Aprepitant Capsule II (Paddle) 100 2.2% sodium dodecyl sulfate in distilled water 900 10, 15, 20, 30 and 45 01/20/2006
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
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 Refer to USP 06/24/2010
Aspirin/Butalbital/Caffeine Tablet Refer to USP 06/24/2010
Aspirin/Butalbital/Caffeine/Codeine Phosphate Capsule Refer to USP 08/27/2009
Aspirin/Caffeine/Orphenadrine Citrate Tablet I (Basket) 75 Water (deaerated) 900 10, 20, 30, 45 and 60 01/15/2004
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 hrs 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 I (Basket) 100 Water (deaerated) 900 10, 20, 30, 45, 60 and 90 01/15/2004
Aspirin/Methocarbamol Tablet II (Paddle) 50 Water (deaerated) 900 10, 20, 30, 45, 60 and 90 01/15/2004
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 USP  02/14/2014
Atenolol/Chlorthalidone Tablet  Refer to USP  02/14/2014
Atomoxetine HCl Capsule II (Paddle) 50 0.1 N HCl 1000 10, 20, 30 and 45 12/20/2005
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 II (Paddle) 50 Water (deaerated) 900 10, 20, 30, and 45 01/15/2004
Avanafil Tablet  II (Paddle) 50 Simulated gastric fluid without pepsin. 900 5, 10, 15, 20 and 30 04/02/2015
Axitinib Tablet  II (Paddle) 75 0.01 N HCl 900 5, 15, 30, 45 and 60 08/14/2014
Azacitidine Injectable Suspension Develop a dissolution method 09/03/2008
Azathioprine Tablet Refer to USP 04/08/2010
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 Refer to USP 12/15/2009
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
Balsalazide Disodium Capsule II (Paddle) with sinker 50 pH 6.8 buffer 900 10, 20, 30, and 45 01/26/2006
Balsalazide Disodium Tablet II (Paddle) 100 Water (degassed) 1000 10, 20, 30, 45, 60, 75, 90 and 120  07/31/2013
Bedaquiline Fumarate Tablet  I (Basket) 150 0.01 N HCl 900 10, 15, 20, 30 and 45 06/06/2013
Benazepril HCl Tablet II (Paddle) 50 Water (deaerated) 500 10, 20, 30 and 45 01/16/2004
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 Refer to USP 12/24/2015
Benzphetamine HCl Tablet II (Paddle) 50 Water 900 10, 20 , 30, and 45 06/20/2007
Bepridil HCl Tablet I (Basket) 100 0.1 N HCl 900 10, 20, 30, 45 and 60 01/16/2004
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 USP 10/06/2008
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 II (Paddle) 50 1% SLS in water 1000 10, 20, 30, 45 and 60 12/15/2005
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 II (Paddle) 75 Tetracycline and Metronidazole: 0.1 N HCl; Bismuth Subcitrate Potassium: Water 900 5, 15, 20, 30 and 45 10/06/2008
Bisoprolol Fumarate Tablet Refer to USP 06/18/2007
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 II (Paddle)  50 1% SLS in water  900 15, 30, 45 and 60 09/02/2010
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
Brimonidine Tartrate/Brinzolamide Ophthalmic Suspension Develop a method to characterize in vitro release 01/15/2015
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 Refer to USP 07/14/2008
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 Implant II (Paddle  50 Water 900 1, 4, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours 07/28/2016
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 Tablet (Sublingual) I (Basket) 100 Water 500 2, 5, 8, 10, 15, and until at least 80% of the labeled content is dissolved 04/09/2007
Buprenorphine HCl/Naloxone HCl Tablet (Sublingual) I (Basket) 100 Water 500 1, 3, 5, 7.5, 10, 15 and 20 07/01/2010
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 (Extended Release) Refer to USP 07/25/2007
Bupropion HCl Tablet  Refer to USP  08/15/2013
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 USP 07/21/2009
Busulfan Tablet II (Paddle) 50 Water (Deaerated) 500 5, 10, 15 and 30 07/14/2008
Cabergoline Tablet II (Paddle) 50 0.1 N HCl 500 5, 10, 15 and 30 01/20/2004
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
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 Tablet Refer to USP 01/14/2008
Calcium Acetate Capsule II (Paddle)  50 Water 900 5, 10, 15, 20 and 30 07/21/2009
Canagliflozin Tablet II (Paddle)  75 0.75 % sodium lauryl sulfate (SLS) in water 600 5, 10, 15, 20 and 30 06/02/2016
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 II (Paddle) 50 Water (deaerated) 900 10, 20, 30 and 45 01/23/2004
Captopril Tablet Refer to USP  10/20/2016
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  Refer to USP  12/24/2015
Carbamazepine Tablet (Chewable) II (Paddle 75 1% SLS in Water  900 15, 30, 45, 60 and 90 12/23/2010
Carbamazepine Suspension II (Paddle) 50 Water (deaerated) 900 10, 20, 30, 45 and 60 01/20/2004
Carbamazepine Tablet (Extended Release) Refer to USP 01/14/2008
Carbidopa Tablet  I (Basket) 50 0.1 N HCl 750 10, 15, 20, 30 and 45 08/14/2014
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 Refer to USP 01/14/2008
Carbidopa/Levodopa Tablet (Orally Disintegrating) II (Paddle) 50 0.1 N HCl 750 5, 10, 15, 30, and 45 07/25/2007
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 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 minutes; Buffer stage: 15, 30, 60, 90, 120, 180 and 240 minutes 04/07/2016
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 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  II (Paddle) 100 0.05M Phosphate Buffer, pH 6.8 750 5, 10, 15, 20 and 30 08/15/2013
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
Carvedilol Phosphate Capsule (Extended Release) II (Paddle) 100 0.1 N HCl 900 1, 4, 8, 12, 18 and 24 hours 04/02/2009
Cefaclor Capsule Refer to USP 03/03/2011
Cefaclor Tablet (Chewable)  Refer to USP 03/03/2011
Cefaclor Tablet (Extended Release)  Refer to USP 03/03/2011
Cefadroxil Tablet Refer to USP  09/02/2010
Cefadroxil Capsule Refer to USP  09/02/2010
Cefadroxil Suspension II (Paddle) 25 Water 900 5, 10, 15, 30 and 45 07/25/2007
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 Suspension II (Paddle) 50 0.05 M Phosphate buffer, pH 7.2 900 10, 20, 30 and 45 04/09/2007
Cefixime Tablet  Refer to USP  12/23/2010
Cefixime Tablet (Chewable) II (Paddle 25 Phosphate Buffer, pH 7.2 900 10, 15, 20, 30, and 45 12/23/2010
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 Tablet Refer to USP 07/25/2007
Cefpodoxime Proxetil Suspension II (Paddle) 50 Glycine Buffer (0.04 M) pH 3.0 900 10, 20, 30 and 45 12/20/2005
Cefprozil Tablet Refer to USP 10/04/2012
Cefprozil For Oral Suspension II (Paddle) 25 Water 900 5, 10, 15, 20 and 30  10/04/2012
Cefprozil Tablet Refer to USP 07/25/2007
Cefprozil Monohydrate Suspension II (Paddle) 25 Water (deaerated) 900 5, 10, 15 and 30 01/21/2004
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
Cephalexin Suspension II (Paddle) 25 Water 900 5, 10, 20, and 30 07/25/2007
Cephalexin Capsule Refer to USP 04/02/2009
Ceritinib Capsule II (Paddle) 60 0.01 M HCl (degassed) 900 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 (Regular & Chewable) II (Paddle) 50 Water (deaerated) 900 10, 20, 30 and 45 03/04/2006
Cetirizine HCl Tablet (Orally Disintegrating)  Refer to USP 03/17/2016
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 II (Paddle) with option to use a sinker 50 0.1 N HCl 900 5, 10, 15, and 30 01/26/2006
Chlorambucil Tablet II (Paddle) 75 0.1 N HCl 900 10, 20, 30, and 45  08/17/2006
Chlordiazepoxide HCl/ Clidinium Bromide Capsule Refer to USP (provide individual unit data). 03/02/2017
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 Capsule (Extended Release) II (Paddle) 50 Simulated Intestinal Fluid without enzyme 500 1, 4, 12, and 24 hours 11/25/2008
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
Chlorpromazine HCl Tablet  Refer to USP  01/05/2012
Chlorthalidone Tablet Refer to USP 04/15/2008
Chlorzoxazone Tablet Refer to USP 01/14/2008
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 II (Paddle) 75 0.3% SLS in water 900 15, 30, 45, 60 and 90 08/17/2006
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 (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 Tablet Refer to USP  09/02/2010
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 HBr Tablet Refer to USP 01/14/2008
Citalopram Hydrobromide Capsule II (Paddle) 50 0.1 N HCl 900 10, 20, 30 and 45 10/06/2008
Clarithromycin Tablet (Extended Release) Refer to USP 10/06/2008
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 Refer to USP 07/25/2007
Clindamycin HCl Capsule Refer to USP  09/01/2011
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  Refer to USP  08/15/2013
Clomipramine HCl Capsule Refer to USP 08/27/2015
Clonazepam Tablet Refer to USP 04/08/2010
Clonazepam Tablet (Orally Disintegrating) II (Paddle) 50 Water 900 5, 10, 15, 30, and 45 07/25/2007
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 USP 07/25/2007
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 Tablet  Refer to USP   07/21/2011
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 Suspension II (Paddle) 50 Acetate Buffer (pH 4.0) 900 5, 10, 15, 20 and 30 05/28/2015
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  II (Paddle) 50 50 mM Acetate Buffer, pH 4.5 900 5, 10, 15, 20 and 30 06/30/2016
Codeine Sulfate Tablet  Refer to USP  09/01/2011
Colchicine Capsule   II (Paddle) 75 Deionized Water with 2% Sodium Lauryl Sulfate (SLS) 500 5, 10, 15, 20 and 30 12/22/2016
Colchicine Tablet Refer to USP  08/05/2010
Colesevelam HCl Tablet Disintegration Testing as per USP <701> in various media such as deionized water, 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 I (Basket) 100 Water (deaerated) 900 10, 20, 30, 45 and 60 01/24/2004
Cycloserine Capsule Refer to USP  05/09/2013
Cyclosporine Capsule  Refer to USP 03/17/2016
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 USP 05/28/2015
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
Cysteamine Bitartrate Capsule I (Basket) 75 0.1 N HCl 900 10, 20, 30 and 45 01/24/2004
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 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
Dantrolene Sodium For suspension (intravenous ) II (Paddle) 50 0.5% Benzalkonium Chloride in water 900 0.5, 1, 2, 3, 5 and 10 minutes 03/02/2017
Dapagliflozin Propanediol Tablet II (Paddle) 60 Acetate Buffer, pH 4.5 1000 5, 10, 15, 20 and 30 05/28/2015
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
Dapsone Tablet  Refer to USP  12/23/2010
Dapsone Gel (Topical)  Develop a method to characterize in vitro release  07/28/2016
Darifenacin Hydrobromide Tablet (Extended Release) I (Basket) 100 0.01N HCl Comparative dissolution data should also be provided in 900 ml pH 4.5 buffer, pH 6.8 buffer, and water using Apparatus I (Basket) at 100 RPM. 900 1, 4, 8, 12, 16, 20 and 24 hours 01/20/2006
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 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
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
Deferiprone Tablet II (Paddle) 50 0.1 N HCl 1000 5, 10, 20, 30, 45 and 60 06/25/2015
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 Refer to USP 07/25/2007
Demeclocycline HCl Tablet Refer to USP 07/25/2007
Desipramine HCl Tablet Refer to USP 01/31/2013
Desloratadine Tablet II (Paddle) 50 0.1 N HCl 500 15, 20, 30 and 45 03/04/2006
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 II (Paddle) 75 Water (deaerated) 500 10, 20, 30 and 45 12/15/2005
Desogestrel/Ethinyl Estradiol Tablet Refer to USP 11/04/2008
Desvenlafaxine Succinate Tablet (Extended Release) I (Basket) 100 0.9% NaCl in water 900 1, 2, 4, 8, 12, 16, 20 and 24 hours 04/02/2009
Dexamethasone Tablet Refer to USP 04/02/2009
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/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 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
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
Dexmethylphenidate HCl Tablet I (Basket) 100 Water 900 10, 15, 30, and 45 06/18/2007
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
Dextroamphetamine Sulfate Tablet I (Basket) 100 Water 500 10, 20, 30, 45 and 60  01/31/2013
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
Diazepam Gel (Rectal) II (Paddle) 50 0.05 M Phosphate Buffer, pH 6.8 500 5, 10, 15, 30 and 45 04/02/2009
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) II (Paddle) (miso) 100 (diclo) 50 (miso) Diclofenac: Acid Stage: 0.1 N HCl Buffer Stage: 750ml 0.1N HCL+250ml 0.2M phos.buffer, pH 6.8 (Method A) Misoprostol: Water (deaerated) Diclo: Acid: 750 Buffer:1000 Miso: 500 Diclo.: 120 (acid) 15, 30, 45 and 60 (Buffer). Miso:10, 20 and 30 12/15/2005
Dicloxacillin Sodium Capsule Refer to USP 06/18/2007
Didanosine Tablet (Chewable) II (Paddle) 75 Water (deaerated) 900 10, 20, 30 and 45 01/26/2004
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 II (Paddle) 50 0.4% SLS in water 900 10, 15, 20, 30 and 45   06/07/2012
Diethylpropion HCl Tablet (Extended Release) I (Basket) 100 Water (deaerated) 900 1, 3, 5, 7 and 9 hours 05/20/2009
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 (AB2) Capsule (Extended Release) Refer to USP 02/19/2008
Diltiazem HCl (AB3) Capsule (Extended Release) Refer to USP 02/19/2008
Diltiazem HCl (AB4) Capsule (Extended Release) Refer to USP 02/19/2008
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) II (Paddle) 50 Deionized Water 500 0.25, 0.5, 1, 2, 2.5, 3, 3.5, 4 and 5 hours  09/01/2011
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
Disopyramide Phosphate Capsule Refer to USP 09/03/2008
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 I (Basket) 100 0.001 M HCL 900 10, 15, 30 and 45 01/20/2006
Dolasetron Mesylate Tablet Refer to USP 07/01/2010
Dolutegravir Sodium 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 and 30 05/28/2015
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 Tablet  Refer to USP 03/17/2016
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
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 USP  08/05/2010
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 Suspension II (Paddle) 25 0.01 N HCl 900 5, 10, 15 and 20 09/03/2008
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 Hyclate Capsule Refer to USP 07/14/2008
Doxycycline Hyclate Tablet  Refer to USP 03/17/2016
Doxycycline Hyclate ( 150 mg and 75 mg) Tablet II (Paddle) 75 Water 900 5, 10, 15, 20 and 30 05/28/2015
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 minutes; Buffer stage: 5, 10, 15, 20 and 30 minutes 01/19/2017
Dronabinol Capsule II (Paddle) 100 and 150 10% Labrasol in Water; (In addition, the USP capsule rupture test should also be conducted) 500 5, 10, 15, 30, 45, 60, and until at least 80% of the labeled content is released 01/31/2007
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/Estradiol Tablet II (Paddle) 50 Water 900 10, 20, 30, and 45 01/03/2007
Drospirenone/Ethinyl Estradiol Tablet  Refer to USP  07/28/2016
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 I (Basket) 100 0.1N HCl 900 5, 10, 15, 20 and 30 05/28/2015
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
Efavirenz Capsule II (Paddle) A sinker may be used with justification if necessary. 50 1% Sodium Lauryl Sulfate in water 900 15, 30, 45 and 60 03/22/2006
Efavirenz Tablet II (Paddle) 50 2% SLS in water 1000 10, 15, 30, 45, 60 06/18/2007
Efavirenz 600 mg; Emtricitabine 200 mg; Tenofovir Disoproxil Fumarate 300 mg Tablet II (Paddle) 100 2% SLS in water 1000 10, 20, 30, and 45  01/03/2007
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
Eliglustat Tartrate Capsule II (Paddle) with sinker 75 0.1 N HCl 900 10, 15, 20, 30 and 45 05/28/2015
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
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
Eluxadoline Tablet  I (Basket) 100 0.05M Phosphate Buffer, pH 4.5 900 5, 10, 15, 20 and 30 03/17/2016
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 II (Paddle) 75 0.05 M Phosphate Buffer, pH 6.8 900 5, 10, 15, 20 and 30 05/28/2015
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/Metformin HCl Tablet  II (Paddle) 50 Phosphate Buffer, pH 6.8 (degas) 900 5, 10, 15, 20 and 30 06/30/2016
Empagliflozin/Metformin Hydrochloride Tablet II (Paddle) 50 Phosphate Buffer, pH 6.8 (deaerated) 900 5, 10, 15, 20 and 30 10/20/2016
Emtricitabine Capsule II (Paddle) 50 Tier 1: 0.1 N HCl Tier 2: 0.1 N HCl containing Pepsin 750,000 USP units/L. Tier 2 is used after failure of Tier 1 testing 900 10, 20, 30 and 45 12/16/2005
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 II (Paddle) 50 Phosphate buffer pH 6.8 (50mM) 1000 10, 20, 30, and 45 06/21/2006
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
Eplerenone Tablet II (Paddle) 50 0.1 N HCl 1000 10, 20, 30 and 45 12/19/2005
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 0.1 N HCl containing 1% SDS 1000 15, 30, 45 and 60 03/22/2006
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 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 II (Paddle) 75 0.1 N HCl 900 10, 20, 30 and 45 02/20/2004
Escitalopram Oxalate Capsule II (Paddle) 50 0.1 N HCl 900 10, 20, 30 and 45 10/06/2008
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 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 (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
Estazolam Tablet II (Paddle) 50 Water (deaerated) 900 10, 20, 30 and 45 01/27/2004
Esterified Estrogens Tablet II (Paddle) 50 Water 900 15, 30, 45, 60, 90, 120 and 180 02/19/2008
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 Vaginal Ring Incubator shaker 130 0.9% Saline 250 1, 9, 16, 17, 18, 19, 45 days 01/03/2007
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/Norethindrone Acetate Tablet  Refer to USP  01/05/2012
Estradiol/Norgestimate (1mg/0.09mg) Tablet II (Paddle) 50 0.3% SLS in water 500 10, 20, 30 and 45 07/09/2004
Estramustine Phosphate Sodium Capsule I (Basket)  100 Water 900 10, 20, 30 and 45 07/15/2009
Estrogens Conjugated Synthetic A Tablet I (Basket)  50 Water 900 1, 2, 3, 5, 8, 10 and 12 hours 09/02/2010
Estrogens, Conjugated (EC)/Medroxyprogesterone Acetate (MPA) Tablet II (Paddle) with sinker 50 EC: 0.02 M Na Acetate Buffer (pH 4.5); MPA: 0.54% Sodium Lauryl Sulfate [SLS] in water 900 12/24/2015
Estrogens, Conjugated Synthetic B Tablet II (Paddle) 50 Water 900 2, 5, 8 and 12 hours 10/06/2008
Eszopiclone Tablet II (Paddle) 50 0.1 N HCl 500 10, 20, 30 and 45 09/13/2007
Ethacrynic Acid Tablet  Refer to USP  12/23/2010
Ethambutol HCl Tablet Refer to USP 01/14/2008
Ethinyl Estradiol Tablet  Refer to USP  09/22/2011
Ethinyl Estradiol/Ethynodiol Diacetate Tablet II (Paddle) 75 0.25% Sodium Lauryl Sulfate (SLS) in Water 600 10, 20, 30 and 45 07/14/2008
Ethinyl Estradiol/Etonogestrel Vaginal Ring Develop a method to characterize in vitro release  01/31/2013
Ethinyl Estradiol/Levonorgestrel Tablet Refer to USP 02/19/2008
Ethinyl Estradiol/Levonorgestrel (AB) Tablet Refer to USP 02/19/2008
Ethinyl Estradiol/Levonorgestrel (AB2) Tablet Refer to USP 11/04/2008
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 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 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 II (Paddle) 75 0.05% Tween 20 in water 600 5, 10, 20 and 30 01/14/2008
Ethinyl Estradiol/Norgestimate (AB) Tablet II (Paddle) 75 0.05% Tween 20 in water 600 10, 20, 30 and 45 01/14/2008
Ethinyl Estradiol/Norgestrel Tablet II (Paddle) 75 Water with 5 ppm of Tween 80 500 10, 20, 30, 45, 60 and 90 01/28/2004
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 USP 04/15/2008
Etidronate Disodium Tablet Refer to USP 06/18/2007
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 II (Paddle)  50 Water with 0.4% sodium dodecylsulfate 500 10, 20, 30 and 45 07/01/2010
Exemestane Tablet I (Basket) 100 0.5%(w/v) SLS Solution 900 10, 20, 30 and 45 08/17/2006
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 II (Paddle) 50 0.1 N HCl 900 10, 20, 30 and 45 04/09/2007
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 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 06/18/2007
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
Felbamate Suspension II (Paddle) 50 Water (deaerated) 900 5, 10, 15 and 30 01/28/2004
Felbamate Tablet Refer to USP  08/15/2013
Felodipine Tablet (Extended Release) Refer to USP 01/14/2008
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) II (Paddle) 75 0.025 M SLS in water 1000 10, 20, 30, 40 and 60 06/03/2008
Fenofibrate (40 mg and 120 mg) Tablet  II (Paddle 75 0.75% Sodium lauryl sulfate in water  900 5, 10, 20, 30, 45 and 60  10/21/2010
Fenofibrate (48 mg and 145 mg) Tablet  II (Paddle 50 25 mM Sodium lauryl sulfate in water 1000  5, 10, 20, 30, 45 and 60  10/21/2010
Fenofibrate (54 mg and 160 mg) Tablet  II (Paddle 50 0.05 M Sodium lauryl sulfate in water 1000  5, 10, 20, 30, 45 and 60  10/21/2010
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
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
Fexofenadine HCl Suspension II (Paddle) 50 0.001 N HCl 900 10, 20, 30 and 45 11/25/2008
Fexofenadine HCl Tablet II (Paddle) 50 0.001 N HCl 900 5, 10, 20, 30 and 45 02/19/2004
Fexofenadine HCl Capsule II (Paddle) 50 Water (deaerated) 900 10, 20, 30, 45 and 60 01/29/2004
Fexofenadine HCl Tablet (Orally Disintegrating) II (Paddle) 50 0.001 N HCl 500 5, 10, 15, 30 and 45 09/03/2008
Fexofenadine HCl/Pseudoephedrine HCl Tablet (Extended Release) Refer to USP 04/02/2009
Fidaxomicin Tablet  II (Paddle)  75 Water with 2% Tween 80  900 10, 15, 30, 45 and 60 04/14/2016
Finafloxacin Otic Suspension Develop a method to characterize in vitro release 03/17/2016
Finasteride Tablet Refer to USP 07/25/2007
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
Flavoxate HCl Tablet I (Basket) 100 0.1 N HCl 900 5, 10, 20 and 30 01/29/2004
Flecainide Acetate Tablet Refer to USP 12/15/2009
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 II (Paddle) 50 Water (deaerated) 900 (For 150, 200, 300 & 400 mg tabs) 500 (For 50 & 100 mg tabs) 10, 20, 30, 45 and 60 03/04/2006
Fluconazole (200 mg/5 mL) Suspension II (Paddle) 50 Water (deaerated) 900 10, 20, 30 and 45 01/30/2004
Fluconazole (50 mg/5 mL) Suspension II (Paddle) 50 Water (deaerated) 500 10, 20, 30 and 45 01/30/2004
Flucytosine Capsule Refer to USP 06/24/2010
Fludarabine Phosphate Tablet II (Paddle) 50 Water  900 5, 10, 15, 20 and 30  06/07/2012
Fludrocortisone Acetate Tablet Refer to USP 05/20/2009
Fluoxetine Capsules (Delayed Release) Refer to USP 07/25/2007
Fluoxetine HCl Capsule Refer to USP  09/02/2010
Fluoxetine HCl Tablet  Refer to USP   04/14/2016
Fluoxetine/Olanzapine Capsule II (Paddle) 50 0.1 N HCl 900 10, 20, 30 and 45 08/17/2006
Flutamide Capsule Refer to USP 01/31/2013
Fluvastatin Sodium Capsule Refer to USP 01/14/2008
Fluvastatin Sodium Tablet (Extended Release) I (Basket)  50 Water (deaerated)  1000 0.5, 2, 4, 6 and 8 hours  09/22/2011
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 II (Paddle) 50 Water (deaerated) 900 10, 20, 30 and 45  01/03/2007
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
Fosinopril Sodium Tablet II (Paddle) 50 Water (deaerated) 900 10, 20, 30 and 45 01/30/2004
Fosinopril Sodium/Hydrochlorothiazide Tablet Refer to USP 08/11/2008
Frovatriptan succinate Tablet II (Paddle) 50 Phosphate Buffer pH 5.5 900 5, 10, 15, 20 and 30 11/04/2008
Furosemide Tablet Refer to USP  08/05/2010
Gabapentin Tablet Refer to USP 06/03/2008
Gabapentin Capsule Refer to USP 06/03/2008
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 Tablet Refer to USP 08/11/2008
Galantamine HBr Capsule (Extended Release) II (Paddle) 50 50 mM potassium dihydrogen phosphate buffer pH 6.5 Comparative dissolution data should also be provided in 900 ml pH 0.1 HCl, pH 4.5 buffer, and water using Apparatus II (Paddle) at 50 RPM. 900 1, 4, 10 and 12 hours 01/20/2006
Ganciclovir Capsule II (Paddle) 60 Water (deaerated) 900 10, 20, 30, 45 and 60 02/02/2004
Gefitinib Tablet II (Paddle) 50 Tween 80 (5% v/v) in water 1000 10, 20, 30, 45 and 60  10/28/2010
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
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 USP 07/25/2007
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 Injectable (Extended Release) Develop a method to characterize in vitro release 12/22/2016
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 HCl Tablet II (Paddle) 50 Phosphate buffer, pH 6.5 500 10, 20, 30, 45 and 60 06/05/2006
Griseofulvin Oral Suspension II (Paddle)  25 and 50 0.54% Sodium Lauryl Sulfate (SLS) in Water 1000 10, 20, 30 and 45  10/28/2010
Griseofulvin (Microcrystalline) Oral Suspension II (Paddle)  25 and 50 0.54% Sodium Lauryl Sulfate (SLS) in Water 1000 10, 20, 30 and 45  10/28/2010
Griseofulvin (Microcrystalline) Tablet Refer to USP  01/15/2010
Griseofulvin (Ultramicrocrystalline) Tablet Refer to USP 11/04/2008
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
Haloperidol Tablet Refer to USP 11/25/2008
Homatropine Methylbromide/Hydrocodone Bitartrate Tablet Refer to USP 10/30/2009
Hydralazine HCl Tablet Refer to USP 04/10/2008
Hydrochlorothiazide Capsule I (Basket) 100 0.1 N HCl 900 10, 20, 30 and 45 02/03/2004
Hydrochlorothiazide Tablet Refer to USP 07/25/2007
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 I (Basket) 100 Water (deaerated) 900 10, 20, 30, 45 and 60 02/03/2004
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 I (Basket) 100 Water (deaerated) 900 5, 10, 20 and 30 02/03/2004
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 Refer to USP  05/09/2013
Hydromorphone HCl Tablet (Extended Release)  VII (Reciprocating holder) (Sample holder-Cage)  30 cycles per min   Water 50 1, 2, 4, 6, 8, 10, 12, 16, 20 and 24 hours  05/26/2016
Hydromorphone HCl Tablet Refer to USP 07/25/2007
Hydroxyurea Capsule Refer to USP 09/03/2008
Hydroxyzine HCl Tablet Refer to USP 07/25/2007
Hydroxyzine Pamoate Capsule Refer to USP 04/02/2009
Hydroxyzine Pamoate Suspension Develop a dissolution method  04/02/2009
Ibandronate Sodium Tablet II (Paddle) 50 Water 500 5, 10, 15, 30 and 45 01/03/2007
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
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 Suspension II (Paddle) 50 0.05 M Phosphate Buffer, pH 7.2 900 5, 10, 15 and 30 02/04/2004
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
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 USP 01/14/2008
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 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
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) Refer to USP 06/25/2015
Isosorbide Dinitrate Tablet Refer to USP 06/25/2015
Isosorbide Dinitrate/Hydralazine HCl Tablet I (Basket) 100 0.05 N HCl 900 10, 15, 20, 25, 30 and 45 06/10/2009
Isosorbide Mononitrate Tablet II (Paddle) 50 Water (deaerated) 900 5, 10, 15 and 30 02/04/2004
Isosorbide Mononitrate Tablet (Extended Release) Refer to USP 11/25/2008
Isotretinoin Capsule I (Basket, with 20 mesh) 100 0.05 M Potassium Phosphate Buffer, dibasic, pH 7.8, containing 0.5% solid LDAO 900 15, 30, 45, 60 and 90 10/06/2008
Isradipine Capsule II (Paddle) 50 0.1% Lauryl Dimethylamine Oxide (LDAO) in water 500 10, 20, 30, 45 and 60 02/25/2004
Isradipine (10 mg) Tablet (Extended Release) II (Paddle) 50 0.2% Lauryl Dimethylamine Oxide (LDAO) in water 1000 2, 4, 8, 12, 16 and 24 hours 02/25/2004
Isradipine (5 mg) Tablet (Extended Release) II (Paddle) 50 0.2% Lauryl Dimethylamine Oxide (LDAO) in water 500 2, 4, 8, 12, 16 and 24 hours 02/25/2004
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 Develop a dissolution method    05/18/2017
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
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
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 Tablet II (Paddle) 50 SIF Buffer without enzyme, pH 7.4 900 10, 20, 30, 45 and 60 02/05/2004
Ketoprofen Capsule II (Paddle) 50 0.05 M Phosphate Buffer pH 7.4 1000 10, 20, 30 and 45 07/25/2007
Ketorolac Tromethamine Tablet Refer to USP 04/15/2008
Labetalol HCl Tablet Refer to USP 08/27/2009
Lacosamide Tablet II (Paddle) 50 0.1 N HCl 900 10, 15, 20, 30 and 45   06/07/2012
Lamivudine (for 100 mg & 150 mg) Tablet II (Paddle) 50 Water (deaerated) 900 10, 20, 30 and 45 03/22/2006
Lamivudine (for 300 mg only) Tablet II (Paddle) 75 0.1 N HCl 900 5, 10, 15 and 30 03/22/2006
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 II (Paddle) 75 Water 900 10, 15, 20, 30 and 45 10/20/2016
Lamivudine/Stavudine/Nevirapine Tablet II (Paddle) 75 0.1 N HCl 900 10, 20, 30, 45 and 60 01/03/2007
Lamivudine/Zidovudine Tablet II (Paddle) 75 0.1 N HCl 900 10, 20, 30 and 45 02/20/2004
Lamivudine/Zidovudine + Efavirenz Tablet (Copackage) II (Paddle) Lamivudine and Zidovudine: 75 Efavirenz: 50 Lamivudine and Zidovudine: 0.1 N HCl Efavirenz: 2% SLS in water Lamivudine and Zidovudine: 1000 Efavirenz: 900 10, 20, 30, and 45  01/03/2007
Lamivudine/Zidovudine + Nevirapine Tablet (Copackage) II (Paddle) 50 Lamivudine and Zidovudine: water Nevirapine: 0.06 M HCl (pH 1.2) 900 10, 15, 30, 45 and 60 01/03/2007
Lamivudine/Zidovudine/ Nevirapine Tablet II (Paddle) 50 0.01 N HCl 900 10, 15, 30, 45 and 60 01/03/2007
Lamotrigine Tablet (Extended Release)  Refer to USP 02/18/2016
Lamotrigine Tablet (Regular) II (Paddle) 50 0.1 N HCl 900 5, 10, 15, 20 and 30 03/04/2006
Lamotrigine Tablet (Chewable dispersible) II (Paddle) 50 0.1 N HCl 900 5, 10, 15, 20 and 30 01/14/2008
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
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
Leflunomide Tablet II (Paddle) 100 Water (deaerated) 1000 10, 20, 30 and 45 02/05/2004
Leflunomide (100 mg) Tablet II (Paddle) 100 Water (deaerated) + 0.6% Polyoxyethylene Lauryl Ether 1000 10, 20, 30 and 45 05/31/2007
Lenalidomide Capsule II (Paddle) 50 0.01 N HCl 900 10, 15, 20, 30 and 45 04/15/2008
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
Letrozole Tablet Refer to USP 04/10/2008
Leucovorin Calcium Tablet Refer to USP 07/14/2008
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
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
Levetiracetam Tablet II (Paddle) 50 Water (deaerated) 900 5, 10, 15 and 30 02/05/2004
Levocarnitine Tablet Refer to USP 900 08/27/2015
Levocetirizine Dihydrochloride Tablet II (Paddle) 50 Water 900 10, 20, 30 and 45 08/11/2008
Levofloxacin Tablet  Refer to USP  07/28/2016
Levomilnacipran HCl Capsule (Extended Release) II (Paddle) 75 Water (deaerated) 1000 1, 2, 4, 6, 8, 12, 16, 20 and 24 hours 05/28/2015
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
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  I (Basket)  50 0.1 N HCl 900 5, 10, 15, 20, 30 and 45 08/15/2013
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 II (Paddle) 50 0.05 M Phosphate Buffer, pH 6.8 900 5, 10, 20, 30 and 45 01/14/2008
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 II (Paddle) 50 0.1 N HCl 900 5, 10, 15 and 20 10/06/2008
Lisinopril Tablet Refer to USP 01/14/2008
Lithium Carbonate Tablet (Extended Release) Refer to USP 01/14/2008
Lithium Carbonate Capsule Refer to USP 07/25/2007
Lithium Carbonate Tablet Refer to USP 04/10/2008
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
Loperamide HCl Capsule Refer to USP 06/25/2015
Loperamide HCl Tablet Refer to USP (provide individual unit data). 06/25/2015
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/Simethicone Tablet II (Paddle) 75 0.1N HCl 500 10, 15, 20, 30 and 45 08/27/2015
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
Lopinavir/Ritonavir Tablet (Combination) Refer to USP 01/15/2015
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 Tablet (Orally Disintegrating) I (Basket) 50 SGF without enzyme 900 2, 4, 6 and 10 07/14/2008
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 Tablet Refer to USP 01/14/2008
Lorcaserin HCl Tablet  II (Paddle) 50 0.1 N HCl (deaerated) 900 5, 10, 15, 20 and 30  12/22/2016
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
Losartan Potassium Tablet  Refer to USP  01/05/2012
Losartan Potassium Tablet II (Paddle) 50 Water (deaerated) 900 10, 20, 30 and 45 02/06/2004
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/Niacin Tablet (Extended Release) I (Basket) 100 For Niacin: Water; for Lovastatin: 0.05 M phosphate buffer, pH 7.0 with 0.5% sodium dodecyl sulfate 900 For Niacin: 0.5, 1, 2, 3, 6, 9, 12, 20 and 24 hours; For Lovastatin: 15, 30, 45 and 60 min 01/14/2008
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
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 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
Maraviroc Tablet I (Basket)  100 0.01 N HCl 900 10, 15, 20, 30 and 45  10/21/2010
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 minutes 12/22/2016
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 Injectable Suspension  Test 1: IV (Flow through cell), 22.6 mm cell, 13 g of 1 mm beads; Test 2: II (Paddle) Test 1: 17 mL/min; Test 2: 50 rpm Test 1: 0.5 % SDS in water ; Test 2: 0.35 % SDS in water (provide data with both tests) Test 1:use Open Mode: Test 2: 900 mL Test 1: 5, 10, 15, 20, 30, 40, 50, 60, 70, 80 and 90; Test 2: 5, 10, 15, 30, 60, 90, 120, 240, 360, 1440 and 2880 10/31/2013
Medroxyprogesterone Acetate Tablet Refer to USP 12/24/2015
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 Refer to USP 12/15/2009
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 USP 07/14/2008
Memantine HCl Tablet I (Basket) 100 0.1 N HCl with NaCl (12 g NaCl in 6 L water adjust pH to 1.2 with HCl) 900 10, 20, 30 and 45 12/16/2005
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 USP 11/25/2008
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 Refer to USP 10/20/2016
Metformin HCl Tablet Refer to USP 04/10/2008
Metformin HCl Tablet (Extended Release) Refer to USP 12/12/2008
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 USP 07/14/2008
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 USP 07/31/2013
Methimazole Tablet Refer to USP 01/14/2008
Methocarbamol Tablet  Refer to USP  08/15/2013
Methotrexate Sodium Tablet Refer to USP 04/02/2009
Methoxsalen Capsule Refer to USP  03/25/2010
Methylergonovine Maleate Tablet  Refer to USP 03/17/2016
Methylnaltrexone Bromide Tablet II (Paddle) 50 0.1 N HCl 1000 5, 10, 15, 20 and 30 10/20/2016
Methylphenidate Capsule (Extended Release) II (Paddle) 50 Water 500 1, 2, 4, 6, 8, 12 hours and until at least 80% released 04/15/2008
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 Tablet (Extended Release)  Refer to USP  02/14/2014
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 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 Tablet (Chewable)  I (Basket) 100 Water 900 15, 30, 45 and 60 03/25/2010
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 USP (provide individual unit data).
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
Methylprednisolone Tablet Refer to USP  01/29/2010
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 Refer to USP 07/31/2013
Methyltestosterone Tablet II (Paddle) 50 Water 900 10, 20, 30, 45, 60 and 75  07/31/2013
Metoclopramide HCl Tablet (Orally Disintegrating) I (Basket) 50 Water 900 5, 10, 15, 20, 30 and 45 04/08/2010
Metoclopramide HCl Tablet Refer to USP 07/15/2009
Metolazone Tablet II (Paddle) 75 2% SLS in 0.05 M Sodium Phosphate Buffer, pH 7.5 900 30, 60, 90, 120 and 150 02/10/2004
Metoprolol Succinate Tablet (Extended Release) Refer to USP 07/25/2007
Metoprolol Tartrate Tablet Refer to USP 07/25/2007
Metronidazole Tablet Refer to USP  08/05/2010
Metronidazole Capsule I (Basket) 100 0.1 N HCl 900 10, 20, 30 and 45 02/09/2004
Metronidazole Capsule Refer to USP 12/24/2015
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 II (Paddle) 50 0.1 N HCl 900 5, 10, 15 and 30 02/06/2004
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  II (Paddle) 75  Water 900 10, 20, 30, and 45 03/03/2011
Miglustat Capsule I (Basket) 100 0.1 N HCl 1000 10, 20, 30 and 45  01/03/2007
Milnacipran HCl Tablet II (Paddle) 50 0.1 N HCl 900 10, 15, 30, 45 and 60 08/05/2010
Miltefosine Capsule  II (Paddle)  50 0.1 N HCl 750 5, 10, 15, 20 and 30 03/17/2016
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 Tablet Refer to USP 07/25/2007
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 Refer to USP 04/15/2008
Minoxidil Tablet Refer to USP 04/15/2008
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 II (Paddle) 50 0.1 N HCl 900 5, 10, 15 and 30 02/10/2004
Mirtazapine Tablet (Orally Disintegrating (ODT)) II (Paddle) 50 0.1 N HCl 900 5, 10, 15, 20 and 30 03/04/2006
Misoprostol Tablet II (Paddle) 50 Water (deaerated) 500 5, 10, 20 and 30 02/10/2004
Mitotane Tablet Refer to USP 06/10/2009
Modafinil Tablet II (Paddle) 50 0.1 N HCl 900 10, 20, 30, 45 and 60 02/10/2004
Moexipril HCl Tablet II (Paddle) 50 Water (deaerated) 900 5, 10, 15 and 30 02/10/2004
Molindone HCl Tablet Refer to USP 07/25/2007
Montelukast Granule I (Basket) (100 mesh) 50 0.5% w/v SDS in Water 900 5, 15, 20 and 30  09/24/2008
Montelukast Sodium Tablet (Chewable) II (Paddle) 50 0.5% SDS in water 900 5, 10, 20 and 30 03/04/2006
Montelukast Sodium Tablet II (Paddle) 50 0.5% SDS in water 900 5, 10, 20 and 30 04/09/2007
Morphine Sulfate Tablet II (Paddle) 50 Deionized Water 900 5, 15, 20 and 30  01/15/2010
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 Capsule (Extended Release) Refer to USP 08/11/2008
Morphine Sulfate (AB) Tablet (Extended Release)  I (Basket) 50 Water (deaerated) 900 1, 2, 3, 6, 9 and 12 hours 12/23/2010
Morphine Sulfate (AB2) Capsule (Extended Release)  II (Paddle) 50 Phosphate Buffer, pH 6.8 900 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24 hours 08/14/2014
Morphine Sulfate (BC) Tablet (Extended Release)  I (Basket) 100 Water 500 1, 2, 4, 6, 8, 10 and 12 hours 12/23/2010
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 II (Paddle) 50 0.1 N HCl 900 15, 30, 45 and 60 06/18/2007
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 Refer to USP 07/25/2007
Nadolol Tablet Refer to USP 04/02/2009
Naloxegol Oxalate Tablet II (Paddle) 50 0.1 N HCl 500 5, 10, 15, 20 and 30 05/28/2015
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 USP 04/15/2008
Naltrexone HCl / Oxycodone HCl Capsule (Extended Release)  Develop a dissolution method 12/22/2016
Naltrexone HCl/Bupropion HCl Tablet (Extended Release) II (Paddle) 50 Water (degassed) 900 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hours 09/03/2015
Naproxen Tablet Refer to USP 07/25/2007
Naproxen Tablet (Delayed Release)  Refer to USP 12/15/2009
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 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/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 USP 07/25/2007
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 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
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
Niacin Tablet (Extended Release) I (Basket) 100 Water 900 1, 3, 6, 9, 12, 15, 20 and 24 hours 06/10/2009
Niacin/Simvastatin Tablet (Extended Release)  Niacin: I (40 mesh rotating Basket); Simvastain: I (10 mesh rotating Basket) 100 Niacin: Water; Simvastatin: 0.5 % SDS in 0.01 M Sodium Phosphate, pH 7.0 900 Niacin: 1, 3, 6, 9, 12, 15, 18, 20 and 24 hours; Simvastatin: 10, 20, 30, 45 and 60 01/15/2010
Nicardipine HCl Capsule (Extended Release) II (Paddle) 50 0.1 N HCl 1000 0.5 , 2 and 6 hours 07/14/2008
Nicardipine HCl Capsule II (Paddle) 50 0.033 M Citric Acid Buffer, pH 4.5 900 10, 20, 30 and 45 02/11/2004
Nicotine Film, Transdermal (Extended Release)   Refer to USP 01/31/2013
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) Refer to USP 07/25/2007
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 II (Paddle) 50 0.5% SDS in water 900 10, 20, 30, and 45 04/09/2007
Nintedanib Esylate Capsule II (Paddle) with sinker 100 0.1 N HCl 900 10, 15, 20, 30, 45 and 60 09/03/2015
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 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
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
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 Refer to USP 01/14/2008
Norethindrone Tablet Refer to USP 10/08/2009
Norethindrone Acetate Tablet Refer to USP 08/27/2009
Nortriptyline HCl Capsule Refer to USP 09/03/2015
Nystatin Tablet II (Paddle) 75 Water with 0.1% SLS 900 15, 30, 45, 60 and 90 01/03/2007
Nystatin Oral Suspension II (Paddle) 25, 50 and 75 0.1 % and 0.2% SLS in water 900 5, 10, 20, 30, 45 and 60  10/28/2010
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 I (Basket) 100 0.1 N HCl 900 10, 20, 30 and 45 02/12/2004
Olanzapine Tablet Refer to USP 01/15/2015
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
Olaparib Capsule  II (Paddle)  100 1% Polysorbate 80 in Water 1000 10, 20, 30, 45 and 60  06/02/2016
Olmesartan Medoxomil Tablet II (Paddle) 50 0.05 M Phosphate Buffer, pH 6.8 500 mL (5 mg strength); 1000 mL (20 and 40 mg strength) 10, 15, 20, 30 and 45 04/02/2015
Olsalazine Sodium Capsule I (Basket) 100 Phosphate Buffer, pH 7.5 900 10, 20, 30 and 45 02/12/2004
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 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 Capsule (Delayed Release) Refer to USP 06/18/2007
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 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
Omeprazole Sodium Bicarbonate Capsule II (Paddle) 75 Phosphate Buffer, pH 7.4 900 15, 30, 45 and 60 07/14/2008
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 II (Paddle) 50 Water (deaerated) 500 5, 10, 15 and 30 02/12/2004
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)  Refer to USP 08/27/2009
Oseltamivir Phosphate Oral Supension II (Paddle)  25 0.1 N HCl 900 5, 10, 15, 20 and 30 07/15/2009
Oseltamivir Phosphate Capsule II (Paddle) 50 0.1 N HCl 900 5, 10, 20, and 30 01/03/2007
Osimertinib Mesylate Tablet II (Paddle) 50 0.2 % NaCl solution in water [adjust to pH 1.3] 900 10, 15, 20, 30 and 45 10/20/2016
Ospemifene Tablet II (Paddle)  50 2% Sodium Dodecyl Sulfate (SDS) in Water 900 10, 20, 30, 45, 60 and 75 06/02/2016
Oxaprozin Tablet  Refer to USP 03/17/2016
Oxcarbazepine Tablet (Extended Release)   II (Paddle) with sinker  75 1.0% SDS in Deionized Water (degassed) 900  1, 2, 4, 6, 8 and 10 hours   08/15/2013
Oxcarbazepine Suspension II (Paddle) 75 1% SDS in water 900 10, 20, 30 and 45 02/12/2004
Oxcarbazepine (150 mg) Tablet II (Paddle) 60 0.3% SDS in water 900 10, 20, 30, 45, 60 and 90 02/12/2004
Oxcarbazepine (300 mg) Tablet II (Paddle) 60 0.6% SDS in water 900 10, 20, 30, 45, 60 and 90 02/12/2004
Oxcarbazepine (600 mg) Tablet II (Paddle) 60 1% SDS in water 900 10, 20, 30, 45, 60 and 90 02/12/2004
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 II (Paddle) 50 0.1 N HCl 500 5, 10, 15, 20 and 30 05/28/2015
Oxycodone HCl Tablet (Extended Release)  Refer to USP 03/17/2016
Oxycodone HCl Tablet Refer to USP 01/14/2008
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 Tablets II (Paddle) 50 0.1 N HCl 900 10, 20, 30 and 45 01/14/2008
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
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 II (Paddle) 75 0.1 N HCl 500 10, 15, 30, 45 and 60 08/05/2010
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   I (Basket)   100 0.01 N HCl 900 5, 10, 15, 20 and 30 10/20/2016
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
Pantoprazole Sodium Tablet (Delayed Release)  Refer to USP 07/21/2009
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 I (Basket) 50 0.05 M Phosphate Buffer, pH 6.8 900 5, 10, 15, 20, 30 and 45 02/13/2004
Paroxetine Tablet (Extended Release) Refer to USP 11/19/2015
Paroxetine HCl Tablet Refer to USP 01/14/2008
Paroxetine HCl Suspension II (Paddle) 100 SGF without enzyme 900 10, 20, 30 and 45 02/13/2004
Paroxetine Mesylate Capsule II (Paddle) with wire sinker 75 Simulated Gastric Fluid without enzyme , pH 1.2+0.05 900 5, 10, 15, 20 and 30 02/14/2014
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
Pemoline Tablet II (Paddle) 75 Water (deaerated) 900 10, 20, 30, 45, 60 and 90 02/13/2004
Penbutolol Sulfate Tablet Refer to USP 06/24/2010
Penicillamine Capsule Refer to USP 09/03/2008
Penicillin V Tablet  Refer to USP  06/09/2011
Penicillin V Potassium Tablet  Refer to USP  06/09/2011
Pentosan Polysulfate Sodium Capsule I (Basket) 50 Water 900 5, 15, 30, 45 and 60 04/15/2008
Pentoxifylline Tablet (Extended Release)   Refer to USP  06/09/2011
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 USP 12/15/2009
Phendimetrazine Tartrate Tablet Refer to USP 05/20/2009
Phendimetrazine Tartrate Capsule Refer to USP 06/10/2009
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 II (Paddle) 50 Water 900 10, 20, 30, 45 and 60 08/27/2009
Phentermine HCl Capsule Refer to USP (provide individual unit data). 12/24/2015
Phentermine HCl Tablet (Orally Disintegrating)  II (Paddle) 50 Water 500 mL (15 mg) or 900 mL (30 mg and 37.5 mg)  5, 10, 15, 20 and 30  07/31/2013
Phentermine HCl Tablet Refer to USP 07/15/2009
Phentermine HCl/Topiramate Capsule (Extended Release)  I (Basket) 100 Water (deionized and degassed) 750 Phentermine: 10, 15, 20, 30 and 45; Topiramate: 0.5, 1, 2, 3, 4, 6 and 8 hours 06/06/2013
Phenytoin Tablet (Chewable) Refer to USP 01/14/2008
Phenytoin Suspension Refer to USP 06/18/2007
Phenytoin Sodium Capsule Refer to USP 06/18/2007
Phytonadione Tablet Develop a dissolution method    03/25/2010
Pilocarpine HCl Tablet II (Paddle) 50 0.1 N HCl 500 10, 20, 30, 45 and 60 01/20/2004
Pimavanserin Tartrate Tablet  I (Basket) 100 0.1 N HCl 900 5, 10, 15, 20 and 30 07/28/2016
Pimozide Tablet Refer to USP 02/19/2008
Pindolol Tablet Refer to USP (provide individual unit data). 12/24/2015
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 II (Paddle) with sinker 50 Water (Deionized) 1000 5, 10, 15, 20, 30 and 45 09/03/2015
Piroxicam Capsule Refer to USP 10/04/2012
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 Oral Suspension II (Paddle) 25 0.3% SLS 900 10, 20, 30 and 45 12/03/2007
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
Potassium Chloride Capsule (Extended Release)  Refer to USP  12/24/2015
Potassium Chloride Tablet (Extended Release) Refer to USP 07/25/2007
Potassium Citrate Tablet Refer to USP  08/05/2010
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 II (Paddle) 50 0.023 M Citrate/0.155 M Phosphate Buffer, pH 6.8 500 5, 10, 15, 30 and 45 10/09/2007
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 II (Paddle) 50 Water (deaerated) 900 5, 10, 20 and 30 02/13/2004
Praziquantel Tablet Refer to USP 06/25/2015
Prednisolone Tablet Refer to USP 11/25/2008
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 Refer to USP 12/24/2015
Prednisone Tablet (Delayed Release)  II (Paddle) with sinker  100 Water 500 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8 and 10 hours 07/31/2013
Pregabalin Capsule II (Paddle) with sinker 50 0.06 N HCl 900 10, 20, 30 and 45 01/15/2015
Primaquine Phosphate Tablet Refer to USP 05/28/2015
Primidone Tablet Refer to USP 01/14/2008
Procarbazine HCl Capsules II (Paddle) 50 Water 900 10, 20, 30, 45 and 60 01/14/2008
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
Progesterone Capsule Develop a quantitative rupture test  04/08/2010
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 Tablet Refer to USP 07/25/2007
Promethazine HCl Rectal Suppository  Develop a method to characterize in vitro release 10/20/2016
Propafenone HCl Tablet II (Paddle) 75 0.1 N HCl 900 10, 20, 30 and 45 02/13/2004
Propafenone HCl Capsule (Extended Release) II (Paddle) 50 0-2 hours: 0.08 N HCl 2-15 hours: phosphate buffer, pH 6.8 900 1, 2, 4, 8, 10,12 and 15 hours 03/11/2008
Propranolol HCl Capsule (Extended Release) Refer to USP 07/25/2007
Propranolol HCl Tablet  Refer to USP 03/03/2011
Propylthiouracil Tablet Refer to USP 06/07/2012
Protriptyline HCl Tablet Refer to USP 01/14/2008
Pseudoephedrine HCl Tablet (Extended Release) Refer to USP 01/14/2008
Pseudoephedrine HCl/Triprolidine HCl Tablet Refer to USP 01/15/2010
Pyrazinamide Tablet Refer to USP  10/20/2016
Pyridostigmine Bromide Tablet Refer to USP 06/10/2009
Pyridostigmine Bromide Tablet (Extended Release) II (Paddle) 50 Water 900 1, 2, 4, 6, 8 and 12 hours 06/10/2009
Pyrimethamine Tablet Refer to USP 06/25/2015
Quetiapine Fumarate Tablet II (Paddle) 50 Water (deaerated) 900 10, 20, 30 and 45 02/18/2004
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
Quinapril HCl Tablet Refer to USP 07/25/2007
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 II (Paddle) 50 0.1% Polysorbate 80 in water 1000 10, 20, 30 and 45 02/18/2004
Raltegravir Potassium Tablet (Chewable) II (Paddle) 50 Water(deareated) 900 5, 10, 15, 20 and 30 05/28/2015
Raltegravir Potassium Tablet II (Paddle) with option to use a sinker 100 Water (Deaerated) 900 15, 30, 45, 60 and 120 04/02/2009
Ramelteon Tablet II (Paddle) 50 Water 900 10, 20, 30 and 45 04/02/2009
Ramipril Tablet II (Paddle) 50 0.1 N HCl 500 5, 10, 15 and 30 09/03/2008
Ramipril Capsule II (Paddle) 50 0.1 N HCl 500 10, 20, 30 and 45 02/18/2004
Ranitidine HCl Capsule II (Paddle) 50 Water (deaerated) 900 10, 20, 30 and 45 02/18/2004
Ranitidine HCl Tablet (Effervescent) Develop a dissolution method    04/08/2010
Ranitidine HCl Tablet Refer to USP 07/25/2007
Ranolazine Tablet (Extended Release) II (Paddle) 50 0.1 N HCl 900 0.5, 2, 4, 8, 12, 20, and 24 hours 06/03/2008
Rasagiline Mesylate Tablet II (Paddle) 50 0.1 N HCl 500 10, 15, 30 and 45 01/29/2010
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
Repaglinide Tablet Refer to USP 07/25/2007
Ribavirin Tablet II (Paddle) 50 Water (deaerated) 900 10, 20, 30 and 45 02/18/2004
Ribavirin Capsule I (Basket) 100 Water (deaerated) 900 10, 20, 30 and 45 02/18/2004
Rifabutin Capsule Refer to USP 12/15/2009
Rifampin Capsule Refer to USP 06/18/2007
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 Tablet II (Paddle) 50 0.1 N HCl 900 10, 20, 30, 45 and 60 02/18/2004
Rimantadine HCl Tablet II (Paddle) 50 Water 900 10, 20, 30, and 45  01/03/2007
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
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 Refer to USP 07/01/2010
Risedronate Sodium/Calcium Carbonate Tablet (Copackaged)  For Risedronate Tablets: Refer to USP; For Calcium Carbonate Tablets: Refer to USP. 07/01/2010
Risperidone Injectable 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
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
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 II (Paddle) 50 Water (deaerated) 500 10, 20, 30 and 45  01/03/2007
Rizatriptan Benzoate Tablet (Orally Disintegrating) II (Paddle) 50 Water (deaerated) 900 5, 10 and 15 02/18/2004
Rizatriptan Benzoate Tablet II (Paddle) 50 Water (deaerated) 900 5, 10, 15 and 30 02/18/2004
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 (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
Ropinirole HCl Tablet Refer to USP  05/15/2014
Rosiglitazone Maleate Tablet II (Paddle) 50 0.01M Acetate Buffer, pH 4.0 900 10, 20, 30 and 45 02/24/2004
Rosuvastatin Calcium Tablet II (Paddle) 50 0.05 M Sodium Citrate Buffer pH 6.6 ± 0.05 900 10, 20, 30 and 45 11/10/2010
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 Suspension II (Paddle) 50 2.0% SDS (sodium dodecyl sulfate) in water 900 5, 10, 15, 20 and 30 08/15/2013
Rufinamide Tablet  Refer to USP  08/15/2013
Ruxolitinib Phosphate Tablet II (Paddle) 75 0.1 N HCI 900 5, 10, 15, 20 and 30 06/25/2015
Sacubitril/Valsartan Tablet  II (Paddle) 50 Phosphate Buffer, pH 6.8[degassed] 900 10, 15, 20, 30 and 45 03/17/2016
Sapropterin Dihydrochloride Powder for Oral Solution  II (Paddle)  50 0.1 N HCl 900 2.5, 5, 7.5, 10 and 15 06/02/2016
Sapropterin Dihydrochloride Tablet II (Paddle) 50 0.1 N HCl 900 5, 10, 15 and 20 10/06/2008
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  II (Paddle) 50 0.1 N HCl 900 5, 10, 15, 20, 30 and 45 08/15/2013
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
Selegiline HCl Capsule Refer to USP 01/15/2015
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) I (Basket) 50 Water 500 5, 10, 15 and 20 10/06/2008
Selexipag Tablet  II (Paddle) 50 Phosphate Buffer, pH 6.8 900 5, 10, 15, 20 and 30 03/17/2016
Sertraline HCl Tablet II (Paddle) 75 0.05 M Sodium Acetate Buffer, pH 4.5 900 10, 20, 30 and 45 02/20/2004
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 II (Paddle) with sinker 50 0.1 N HCl 900 5, 10, 15, 20 and 30  06/07/2012
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
Sirolimus Tablet Basket (20 mesh) 120 0.4% SLS in water 500 10, 20, 30, 45, 60 and 120 03/14/2007
Sitagliptin Phosphate Tablet I (Basket) 100 Water 900 5, 10, 15, 20 and 30 07/01/2010
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 I (Basket) 100 Water (deaerated) 500 5, 10, 15 and 30 07/14/2008
Sodium Phenylbutyrate Powder for oral II (Paddle) 75 Simulated Intestinal Fluid 900 15, 30, 45, 60 and 90 04/02/2009
Sodium Phosphate Dibasic Anhydrous/Sodium Phosphate Monobasic Monohydrate Tablet II (Paddle) 100 Water (deionized) 900 20, 30, 45, 60 and 90 01/15/2010
Sofosbuvir Tablet II (Paddle) 75 0.05 M Phosphate Buffer, pH 6.8 900 5, 10, 15, 20 and 30 05/28/2015
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 II (Paddle) 50 Water 900 10, 15, 30 and 45 02/19/2008
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 minutes 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
Spironolactone Tablet Refer to USP 04/15/2008
Stavudine Capsule Refer to USP 06/18/2007
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 II (Paddle) 50 0.1N HCl 900 10, 20, 30, 45 and 60 06/25/2015
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 II (Paddle) 30 0.01 N HCl 900 5, 10, 15 and 30 03/04/2006
Sunitinib Malate Capsule II (Paddle) 50 0.1 N HCl 900 10, 15, 30 and 45 10/30/2009
Suvorexant Tablet II (Paddle) with sinker 75 0.4% Sodium Lauryl Sulfate in Water 900 5, 10, 15, 20, 30 and 45 09/03/2015
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
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
Tadalafil Tablet II (Paddle) 50 0.5% Sodium Lauryl Sulfate 1000 10, 20, 30 and 45 01/26/2006
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 (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
Tapentadol HCl Tablet I (Basket) 75  0.1 N HCl 900 10, 20, 30, 45 and 60  10/28/2010
Tasimelteon Capsule II (Paddle) with sinker 50 0.1 N HCl 500 5, 10, 15, 20 and 30 09/03/2015
Tedizolid Phosphate Tablet II (Paddle)  60 0.05 M phosphate buffer pH 6.8 900 5, 10, 15, 20 and 30 06/02/2016
Telaprevir Tablet II (Paddle)  50 1% SLS in Water  900 5, 10, 15, 20 and 30 05/09/2013
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 I (Basket) 100 Water 500 (for 5 mg); 900 ml (for other strengths) 10, 20, 30, and 45  08/11/2008
Tenofovir Alafenamide Fumarate Tablet  II (Paddle) 75 50 mM Sodium Acetate buffer pH 4.5 500 5, 10, 15, 20 and 30  01/19/2017
Tenofovir Disoproxil Fumarate Tablet II (Paddle) 50 0.1 N HCl 900 10, 20, 30, and 45  01/03/2007
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
Terazosin HCl Tablet II (Paddle) 50 Water (deaerated) 900 10, 20, 30, 45 and 60 02/20/2004
Terazosin HCl Capsule II (Paddle) 50 Water (deaerated) 900 10, 20, 30, 45, 60 and 90 02/20/2004
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 Pellet Implant Develop a dissolution method  11/25/2008
Testosterone Buccal Tablet (Extended Release) II (Paddle, may use sinker) 60 1% sodium dodecyl sulfate in double distilled water 1000 1, 2, 4, 6, 10, 12 and 24 hours 01/03/2007
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
Tetrabenazine Tablet II (Paddle) 50 0.1 N HCl 900 5, 10, 15, 30 and 45  09/01/2011
Tetracycline HCl Capsule Refer to USP 06/24/2010
Tetracycline HCl Tablet Refer to USP  01/29/2010
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 Refer to USP 07/15/2009
Tiagabine HCl Tablet II (Paddle) 50 Water 900 5, 10, 15, 20 and 30 01/03/2007
Ticagrelor Tablet II (Paddle) 75 0.2% w/v Polysorbate 80 in water 900 10, 20, 30, 45, 60 and 75 06/25/2015
Ticlopidine HCl Tablet II (Paddle) 50 Water (deaerated) 900 10, 20, 30, 45 and 60 02/19/2004
Timolol Maleate Tablet Refer to USP 07/31/2013
Tinidazole Tablet I (Basket) 100 Water (Deaerated) 900 10, 20, 30 and 45 01/03/2007
Tiopronin Tablet  I (Basket) 100 0. 08N HCl containing 0.2% w/v NaCl 900 10, 15, 20, 30 and 45 03/02/2017
Tipranavir Capsule II (Paddle) 50 0.05 M phosphate buffer pH 6.8 900 15, 30, 45 and 60 12/03/2007
Tizanidine HCl Capsule II (Paddle) 50 0.01 N HCl 500 5, 10, 15 and 30 02/20/2004
Tizanidine HCl Tablet I (Basket) 100 0.1 N HCl 500 5, 10, 15 and 30 02/20/2004
Tofacitinib Citrate Tablet I (Basket) 100 0.1N HCl 900 5, 10, 15, 20 and 30 06/25/2015
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 II (Paddle) 50 SGF without enzymes, pH 1.2 900 5, 10, 15 and 30 02/20/2004
Tolterodine Tartrate Capsule (Extended Release) I (Basket) 100 Phosphate buffer (pH 6.8) 900 1, 3, 7 hours 06/18/2007
Tolvaptan Tablet II (Paddle)  50 0.22% Sodium Lauryl Sulfate (SLS) in Water 900 10, 15, 20, 30 and 45  02/14/2014
Topiramate Capsule (Sprinkle) II (Paddle) 50 Water (deaerated) 900 10, 20, 30, 45 and 60 02/19/2004
Topiramate Tablet II (Paddle) 50 Water (deaerated) 900 5, 10, 20 and 30 02/19/2004
Topiramate 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 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
Tramadol Capsule (Extended Release) I (Basket) 100 Water (Deaerated ) 900 0.5, 1, 2, 3, 5, 7, 9, 12, 16, 20 and 24 hours 09/03/2015
Tramadol HCl Tablet I (Basket) 100 0.1 N HCl 900 10, 20, 30 and 45 02/19/2004
Tramadol HCl Tablet (Extended Release) I (Basket) 75 0.1 N HCl 900 2, 4, 8, 10 and 16 hours 01/03/2007
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 II (Paddle) 50 Water (deaerated) 500 10, 20, 30, 45 and 60 02/20/2004
Trandolapril/Verapamil HCl Tablet (Extended Release) II (Paddle) 50 For Trandolapril: Water; For Verapamil: 0-1 hour Gastric Fluid w/o Pepsin pH=1.2, 1-8 hour Intestinal Fluid w/o Pancreatin For Trandolapril: 500; For Verapamil: 900 For Trandolapril: 5, 10, 20, 30 and 45; For Verapamil: 1, 2, 3.5, 5 and 8 hours 12/19/2008
Tranexamic Acid Tablet  II (Paddle 50 Water 900 15, 30, 45, 60, 90 and 120 12/23/2010
Tranylcypromine Sulfate Tablet Refer to USP 10/31/2013
Trazodone HCl Tablet Refer to USP 12/15/2009
Trazodone HCl Tablet (Extended Release)  II (Paddle) 50 Water 900 1, 2, 3, 5, 8, 10, 12, 16, 20 and 24 hours  03/02/2017
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
Triamterene Capsule Refer to USP 06/18/2007
Trientine HCl Capsule Refer to USP 07/31/2013
Trimethoprim Tablet Refer to USP  01/29/2010
Trimipramine Maleate Capsule I (Basket) 100 Water (deaerated) 1000 10, 20, 30, 45, 60 and 90 03/04/2006
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 II (Paddle) 50 0.1 N HCl 1000 10, 20, 30 and 45 12/03/2007
Ulipristal Acetate Tablet II (Paddle) 50 0.1 N HCl 900 5, 10, 15, 20 and 30  01/31/2013
Ursodiol Tablet Refer to USP 04/15/2008
Ursodiol Capsules Refer to USP 07/21/2009
Valacyclovir Hydrochloride Tablet II (Paddle) 50 0.1 N HCl 900 10, 20, 30, 45 and 60 08/27/2009
Valganciclovir HCl Tablet Refer to USP 01/15/2015
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 USP 01/14/2008
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 (ODT))  II (Paddle)  50 0.1 N HCl  900 5, 10, 15 and 30  05/15/2014
Vardenafil HCl Tablet II (Paddle) 50 0.1 N HCl 900 5, 10, 15 and 30 12/20/2005
Varenicline Tartrate Tablet I (Basket) 100 0.01 N HCl 500 5, 10, 15 and 30 12/03/2007
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 HCl Capsule (Extended Release) I (Basket) 100 Water 900 2, 4, 8, 12 and 20 hours 01/03/2007
Venlafaxine HCl Tablet (Extended Release)  II (Paddle)  50  Water (deaerated)  900 1, 2, 4, 6, 8, 12, 16, 20 and 24 hours 02/14/2014
Venlafaxine HCl Tablet II (Paddle) 50 Water (deaerated) 900 5, 10, 15 and 30 02/19/2004
Verapamil HCl Capsule (Extended Release) Refer to USP 08/27/2015
Verapamil HCl Tablet (Extended Release)  Refer to USP 06/24/2010
Verapamil HCl Tablet Refer to USP 11/04/2008
Verteporfin Injectable Develop a method to characterize in vitro release. 08/14/2014
Vigabatrin Tablet II (Paddle) 50 Water 900 5, 10, 15, 20 and 30 06/25/2015
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
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
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 Tablet II (Paddle) 50 0.1 N HCl 900 10, 20, 30 and 45 11/25/2008
Voriconazole Suspension II (Paddle) 50 0.1 N HCl 900 10, 20, 30 and 45 01/03/2007
Vorinostat Capsule II (Paddle) with sinker 100 2% Tween 80 in Water 900 5, 15, 30, 45 and 60 09/03/2008
Vortioxetine HBr Tablet II (Paddle) 50 0.1 N HCl 900 10, 15, 20, 30 and 45 05/28/2015
Warfarin Sodium Tablet Refer to USP  01/29/2010
Zafirlukast Tablet II (Paddle) 50 1% w/v Aqueous Sodium Dodecyl Sulfate 1000 10. 30, 30 and 45 10/09/2007
Zalcitabine Tablet Refer to USP 900 02/19/2008
Zaleplon Capsule II (Paddle) 75 Deionized Water 900 5, 10, 20, and 30 01/03/2007
Zidovudine Tablet Refer to USP 07/25/2007
Zidovudine Capsule Refer to USP 06/18/2007
Zileuton Tablet II (Paddle) 50 0.05 M SLS in water 900 10, 20, 30, 45 and 60 02/19/2004
Zileuton Tablet (Extended Release)   II (Paddle) with sinker  75 0.1 M SDS (sodium dodecyl sulfate) in water 900 1, 2, 4, 6, 8, 10 and 12 hours   08/15/2013
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 Orally Disintegrating) II (Paddle) 50 0.1 N HCl 500 5, 10, 15, 20 and 30 06/18/2007
Zolmitriptan Tablet II (Paddle) 50 0.1 N HCl 500 5, 10, 15, 20 and 30 07/21/2009
Zolpidem Tartrate Tablet (Extended Release) Refer to USP  01/05/2012
Zolpidem Tartrate Tablet II (Paddle) 50 0.01 N HCl, pH 2.0 900 5, 10, 15 and 30 02/19/2004
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  II (Paddle) 50  Water (deaerated)  900  10, 20, 30 and 45   01/03/2007

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