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 | Acid Stage: 900 mL; Buffer Stage: 1000 mL | 5, 10, 15, 30 and 45 | 01/03/2007 |
| Abemaciclib | Tablet | II (Paddle) | 75 | 0.01 N HCl | 900 | 5, 10, 15, 20 and 30 | 11/16/2017 |
| Abiraterone Acetate | Tablet | II (Paddle) | 50 | 0.25% SLS in 56.5 mM phosphate buffer, pH 4.5 | 900 | 10, 20, 30, 45 and 60 | 02/28/2013 |
| Acalabrutinib | Capsule | II (Paddle) with sinker | 50 | 0.1 M HCl | 900 | 5, 10, 15, 20, 30 and 45 | 02/08/2018 |
| Acamprosate Calcium | Tablet (Delayed Release) | I (Basket) | 180 | Acid Stage: 0.1 N HCl Buffer Stage: "Citrate-sodium hydroxide" buffer pH 6.8 (150 ml of 2N NaOH, 21.014 gm of citric acid and ultra-pure water to 1000 ml) (Method B) | Media 1: 750 mL pH 1.1±0.1; Media 2: 950 mL pH 6.0±0.1; Media 3: 1000 mL pH 7.5±0.1 | 120 (Acid) 30, 60, 90, 120, and 180 (buffer) | 12/20/2005 |
| Acarbose | Tablet | 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 | 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 |
| Acetazolamide | Tablet | Refer to USP | 07/21/2011 | ||||
| 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 (Chewable) | II (Paddle) | 50 | 0.1 N HCl | 900 | 10, 15, 20, 30 and 45 | 03/17/2016 |
| Albendazole | Tablet | Refer to USP | 08/15/2013 | ||||
| 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 | Capsule (pellet) | I (Basket) | 100 | 0.01 M HCl (degas) | 500 | 5, 10, 15, 20, 30 and 45 | 02/08/2018 |
| 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 (Orally Disintegrating) | II (Paddle) | 50 | 70 mM Potassium Phosphate Buffer, pH 6.0 | 500 | 2, 5, 10, 15 and 20 | 10/06/2008 |
| 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 | ||||
| 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 | Capsule | Refer to USP | 12/23/2010 | ||||
| Amantadine HCl | Tablet | II (Paddle) | 50 | Water (deaerated) | 500 | 10, 20, 30, 45 and 60 | 01/12/2004 |
| 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 | Capsule | Refer to USP | 01/31/2013 | ||||
| Amoxicillin | Tablet | Refer to USP | 01/31/2013 | ||||
| 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 | For Oral Suspension | II (Paddle) | 50 | Water (degassed) | 900 | 5, 10, 15, 20, 30 and 45 | 06/06/2013 |
| 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 | Suspension | II (Paddle) | 75 | Water (deaerated) | 900 | 5, 10, 15 and 30 | 01/14/2004 |
| 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 | ||||
| Amphetamine | Tablet (Extended Release, Orally Disintegrating) | II (Paddle | 75 | Acid Stage: 0.1 N HCl; Buffer Stage: Phosphate Buffer, pH 6.8 | Acid Stage: 900 mL; Buffer Stage: 1000 mL | Acid Stage: 10, 15, 30, 45, 60, 90, 120; Buffer Stage: 5, 10, 15, 30 and 45 | 07/28/2016 |
| Amphetamine | Suspension (Extended Release) | Develop a dissolution method | 12/22/2016 | ||||
| Amphetamine Aspartate/Amphetamine Sulfate/Dextroamphetamine Saccharate/Dextroamphetamine Sulfate | Tablet | 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 Aspartate/Amphetamine Sulfate/Dextroamphetamine Saccharate/Dextroamphetamine Sulfate [12.5, 25, 37.5, 50 mg] | Capsule (Extended Release) | II (Paddle) | 50 | Media 1: pH 1.1±0.1, Dilute HCl 2 hours; Media 2: pH 6.0±0.1, Phosphate Buffer 3rd hour, Media 3: pH 7.5±0.1, Phosphate Buffer for the remainder | Media 1: 750 mL; Media 2: 950 mL; Media 3: 1000 mL | 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours | 11/16/2017 |
| Amphetamine ER | Capsule | II (Paddle) | 50 | 750 ml of dilute HCl, pH 1.1 for the first 2 hours, then add 200 ml of 200 mM phosphate buffer, and adjust to pH 6 (w/ HCl or NaOH) for the remainder | 750 ml of dilute HCl, 200 ml of phosphate buffer | 1, 2, 3, 4, and 6 hours | 08/17/2006 |
| 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 | 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 |
| Aripiprazole | Tablet | Refer to USP | 06/30/2016 | ||||
| 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 hours | 10/09/2007 |
| Aspirin/Hydrocodone Bitartrate | Tablet | II (Paddle) | 75 | Acetate Buffer, pH 4.5 | 900 | 10, 20, 30, 45, 60 and 90 | 01/15/2004 |
| Aspirin/Meprobamate | Tablet | 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 | 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 | Oral Suspension | Develop a dissolution method | 07/21/2009 | ||||
| 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 | Tablet | Refer to USP | 12/22/2016 | ||||
| Azithromycin | Capsule | Refer to USP | 12/22/2016 | ||||
| Azithromycin | Oral Suspension | II (Paddle) | 50 | Phosphate buffer, pH 6.0 | 900 | 10, 20, 30, and 45 | 08/17/2006 |
| Azithromycin | Suspension (Extended Release) | II (Paddle) | 50 | Phosphate Buffer, pH 6.0 | 900 | 15, 30, 45, 60, 120 and 180 | 04/15/2008 |
| Baclofen | Tablet (Orally Disintegrating) | II (Paddle) | 25 | 50 mM Acetate Buffer, pH 4.5 | 500 mL (10 mg) or 1000 mL (20mg) | 5, 10, 15 and 30 | 07/14/2008 |
| Baclofen | Tablet | Refer to USP | 12/15/2009 | ||||
| Balsalazide Disodium | Tablet | II (Paddle) | 100 | Water (degassed) | 1000 | 10, 20, 30, 45, 60, 75, 90 and 120 | 07/31/2013 |
| Balsalazide Disodium | Capsule | II (Paddle) with sinker | 50 | pH 6.8 buffer | 900 | 10, 20, 30, and 45 | 01/26/2006 |
| 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 | ||||
| Betrixaban | Capsule | II (Paddle) with sinker | 75 | 0.01 N HCl, (with addition of pepsin if gelatin crosslinking is observed) | 900 | 5, 10, 15, 20 and 30 | 11/16/2017 |
| 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 (For Suspension) | II (Paddle) | 75 | 0.1 N HCl with 0.5% sodium dodecyl sulfate (SDS), pH 1.1 | 900 | 5, 10, 15, 20 and 30 | 11/16/2017 |
| Bosentan | Tablet | 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 |
| Brigatinib | Tablet | II (Paddle) | 70 | 50 mM Potassium Phosphate Buffer, pH 7.2 | 900 | 5, 10, 15, 20, 30 and 45 | 11/02/2017 |
| Brimonidine Tartrate/Brinzolamide | Ophthalmic Suspension | Develop a method to characterize in vitro release | 01/15/2015 | ||||
| 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 | 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 | 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/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 |
| Buprenorphine HCl/Naloxone HCl | Tablet (Sublingual) | I (Basket) | 100 | Water | 500 | 1, 3, 5, 7.5, 10, 15 and 20 | 07/01/2010 |
| 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 | Capsule | II (Paddle) | 50 | Water | 900 | 5, 10, 15, 20 and 30 | 07/21/2009 |
| Calcium Acetate | Tablet | Refer to USP | 01/14/2008 | ||||
| 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 | Refer to USP | 11/02/2017 | ||||
| Captopril | Tablet | Refer to USP | 10/20/2016 | ||||
| Carbamazepine | Suspension | II (Paddle) | 50 | Water (deaerated) | 900 | 10, 20, 30, 45 and 60 | 01/20/2004 |
| 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 | 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 | 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 | Suspension (Enteral) | II (Paddle) | 25 | 0.05 M Sodium Acetate Buffer, pH 4.5 | 500 | 5, 10, 15, 20, 30, 40 and 60 | 10/20/2016 |
| Carbidopa/Levodopa | Tablet (Orally Disintegrating) | II (Paddle) | 50 | 0.1 N HCl | 750 | 5, 10, 15, 30, and 45 | 07/25/2007 |
| 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 | Tablet (Chewable) | Refer to USP | 03/03/2011 | ||||
| Cefaclor | Tablet (Extended Release) | Refer to USP | 03/03/2011 | ||||
| Cefaclor | Capsule | 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 | 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 |
| Cefixime | Suspension | II (Paddle) | 50 | 0.05 M Phosphate buffer, pH 7.2 | 900 | 10, 20, 30 and 45 | 04/09/2007 |
| 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 | Capsule | Refer to USP | 04/02/2009 | ||||
| Cephalexin | Suspension | II (Paddle) | 25 | Water | 900 | 5, 10, 20, and 30 | 07/25/2007 |
| 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 (Orally Disintegrating) | Refer to USP | 03/17/2016 | ||||
| Cetirizine HCl | Tablet (Regular & Chewable) | II (Paddle) | 50 | Water (deaerated) | 900 | 10, 20, 30 and 45 | 03/04/2006 |
| 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 | ||||
| Chlorothiazide | Suspension | Develop a dissolution method | 03/07/2019 | ||||
| Chlorpheniramine Maleate | Tablet (Extended Release) | III (Reciprocating Cylinder) | 27 dpm | Row 1: Test Fluid 1 (0.1N HCl) for 1st hour. Row 2: Test fluid 2 (Phosphate Buffer, pH 7.5) for 5th hour | Row 1: 250 mL. Row 2: 250 mL | 1 hour for test fluid 1, and 4 hours for test fluid 2 | 07/25/2007 |
| Chlorpheniramine Maleate/Codeine Phosphate | Tablet (Extended Release) | II (Paddle) | 50 | Simulated gastric fluid (SGF) without enzyme (pH 1.2) | 900 | 0.5, 1, 2, 4, 6, 8 and 12 hours | 10/20/2016 |
| Chlorpheniramine Maleate/Ibuprofen/Phenylephrine HCl | Tablet | II (Paddle) | 50 | 50 mM Potassium Phosphate Buffer, pH 6.5 (degassed) | 900 | 5, 10, 15, 20 and 30 | 06/25/2015 |
| Chlorpheniramine Maleate/Ibuprofen/Pseudoephedrine HCl | Tablet | II (Paddle) | 50 | 0.05 M Phosphate Buffer, pH 6.5 | 900 | 10, 20, 30 and 45 | 02/20/2004 |
| Chlorpheniramine Polistirex/ Codeine polistirex | Suspension (Extended Release) | II (Paddle) | 50 | Acid Stage: 0.1 N HCl; Buffer Stage: pH 6.8 Phosphate Buffer [500 mL 0.1 N HCl for 1 hour, followed by addition of 400 mL of 0.2M NaH2P04 to pH 6.8] | Acid Stage: 500 mL; Buffer Stage: 900 mL | Acid Stage: 1 hour; Buffer Stage: 1, 2, 4, 6, 8 and 12 hours | 03/17/2016 |
| Chlorpheniramine Polistirex/Hydrocodone Polistirex | 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 | 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 | 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 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 (Orally Disintegrating) | II (Paddle) | 50 | Water | 900 | 5, 10, 15, 30, and 45 | 07/25/2007 |
| Clonazepam | Tablet | Refer to USP | 04/08/2010 | ||||
| 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 | Oral Suspension | II (Paddle) | 75 | 0.05% Polysorbate 20 in 0.05M Phosphate Buffer, pH 6.8 | 900 | 5, 10, 15, 20, 30 and 45 | 06/25/2015 |
| Darunavir Ethanolate | Tablet | II (Paddle) | 75 | 2% Tween-20 in 0.05 M Sodium Phosphate Buffer, pH 3.0 | 900 | 10, 20, 30, and 45 | 09/13/2007 |
| 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 | II (Paddle) | 75 | 0.5% Tween 20 in Phosphate Buffer, pH 6.8 | 900 | 5, 10, 15, 20 and 30 | 03/17/2016 |
| Deferasirox | Granule | II (Paddle) | 75 | Phosphate Buffer, pH 6.8 with 0.5% Tween 20 | 900 | 5, 10, 15, 20 and 30 | 11/02/2017 |
| 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 |
| Deferiprone | Tablet | II (Paddle) | 50 | 0.1 N HCl | 1000 | 5, 10, 20, 30, 45 and 60 | 06/25/2015 |
| Delafloxacin Meglumine | Tablet | II (Paddle) | 60 | 0.05 M Phosphate Buffer, pH 7.4 (degassed) | 900 | 5, 10, 15, 20 and 30 | 11/16/2017 |
| Delavirdine Mesylate | Tablet | II (Paddle) | 50 | 0.05 M Phosphate Buffer, pH 6.0 containing 0.6% w/v SDS | 900 | 10, 20, 30, 45 and 60 | 12/03/2007 |
| Demeclocycline HCl | Capsule | 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 |
| Deutetrabenazine | Tablet | II (Paddle) over a disk (62 mm with 16 mesh) | 75 | pH 3.0 Acid Phthalate Buffer | 500 | 0.5, 1, 1.5, 2, 3, 4, 5 and 6 hours | 11/02/2017 |
| Dexamethasone | 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 | Tablet | Refer to USP | 04/02/2009 | ||||
| Dexamethasone/Neomycin Sulfate/ Polymyxin B Sulfate | Ophthalmic Suspension | Develop a method to characterize in vitro release | 02/15/2018 | ||||
| Dexamethasone/Tobramycin | Ophthalmic Suspension | Develop a method to characterize in vitro release | 04/02/2009 | ||||
| Dexbrompheniramine Maleate/Pseudoephedrine Sulfate | Tablet (Extended Release) | III (Reciprocating Cylinder) | 12 dpm | 0.02N HCl (2 hours) followed by 0.05M Phosphate Buffer pH 7.5 | 250 | 0.5, 1, 2, 3, 4, 6 and 8 hours | 05/28/2015 |
| Dexlansoprazole | Capsule (Delayed Release) | I (Basket) | 100 | Acid Stage: 0.1 N HCl, Buffer Stage: pH 7.0 Phosphate Buffer with 5 mM SLS | Acid Stage: 500; Buffer stage: 900 | Acid Stage: 120; Buffer Stage: 10, 20, 40, 50, 60 , 75, 105 and 120 | 08/05/2010 |
| Dexlansoprazole | Tablet (Delayed Release, Orally Disintegrating) | I (Basket -100 mesh) | 100 | Acid Stage: 0.1 N HCl; Buffer Stage: pH 7.2 Phosphate Buffer with 5 mM Sodium lauryl sulfate | Acid Stage: 500 mL; Buffer Stage: 900 mL | Acid Stage: 120; Buffer Stage: 10, 15, 20, 30, 50, 60, 75 and 90 | 07/28/2016 |
| 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 | Capsule (Extended Release) | I ( Basket) | 100 | 0.1 N HCl | 500 | 1, 4, 8 and 12 hours | 11/25/2008 |
| Dextroamphetamine Sulfate | Tablet | I (Basket) | 100 | Water | 500 | 10, 20, 30, 45 and 60 | 01/31/2013 |
| 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 Suppository | Develop a method to characterize in vitro release | 10/04/2012 | ||||
| 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 |
| 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 (Extended Release) | Refer to USP | 06/30/2016 | ||||
| Divalproex Sodium | Capsule (Delayed Release) | Refer to USP | 06/30/2016 | ||||
| Divalproex Sodium | Tablet (Delayed Release) | Refer to USP | 07/25/2007 | ||||
| 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 Na/Rilpivirine HCl | Tablet | II (Paddle) | 75 | 1.0 % Tween 20 in 0.01 M HCl, pH 2.0 | 900 | 10, 15, 20, 30, 45 and 60 | 02/08/2018 |
| Dolutegravir Sodium (10 mg) | Tablet | II (Paddle) | 50 | 0.01M pH 6.8 phosphate buffer | 900 | 5, 10, 15, 20, 30 and 45 | 10/18/2018 |
| Dolutegravir Sodium (25 mg) | Tablet | II (Paddle) | 50 | 0.01M pH 6.8 phosphate buffer containing 0.15% w/v sodium dodecyl sulfate (SDS) | 900 | 5, 10, 15, 20, 30 and 45 | 10/18/2018 |
| Dolutegravir Sodium (50 mg) | Tablet | II (Paddle) | 50 | 0.01M pH 6.8 phosphate buffer containing 0.25% w/v sodium dodecyl sulfate (SDS) | 900 | 5, 10, 15, 20, 30 and 45 | 10/18/2018 |
| Donepezil HCl/Memantine HCl | Capsule (Extended Release) | I (Basket) | 100 | pH 1.2 NaCl/HCl buffer | 900 | Donepezil: 5, 10, 15, 20 and 30 minutes; Memantine: 1, 2, 3, 4, 6, 8, 10 and 12 hours | 05/28/2015 |
| Donepezil HCl | Tablet | Refer to USP | 03/17/2016 | ||||
| Donepezil HCl | Tablet (Orally Disintegrating (ODT)) | II (Paddle) | 50 | 0.1 N HCl | 900 | 10, 20, 30 and 45 | 03/04/2006 |
| 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 Calcium | Suspension | Develop a dissolution method | 03/07/2019 | ||||
| Doxycycline Hyclate | Capsule | Refer to USP | 07/14/2008 | ||||
| Doxycycline Hyclate | Tablet | Refer to USP | 03/17/2016 | ||||
| Doxycycline Hyclate ( 120 mg and 60 mg) | Tablet (Delayed Release) | I (Basket) | 100 | Acid stage: 0.06 N HCl; Buffer stage: Neutralized Phthalate Buffer, pH 5.5 | Acid stage: 900 mL; Buffer stage: 900 mL | Acid stage: 10, 20, 30, 45 and 60; Buffer stage: 5, 10, 15, 20, 30 and 45 | 03/27/2018 |
| Doxycycline Hyclate ( 150 mg and 75 mg) | Tablet | 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 | Tablet | II (Paddle) | 50 | 0.5% Polysorbate 80 in Phosphate Buffer, pH 6.8 | 900 | 10, 15, 20, 30, 45, and 60 | 06/07/2012 |
| Eltrombopag Olamine | Suspension | II (Paddle) | 50 | 50 mM potassium phosphate in water, pH 6.8 with 0.2% polysorbate 80 | 750 | 4, 8, 12, 15 and 20 | 10/20/2016 |
| Eluxadoline | Tablet | 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 | 0.02% Tween 80 in 0.01 N HCl | 1000 | 5, 10, 15, 20, 30 and 45 | 10/18/2018 |
| Erythromycin | Tablet (Delayed Release) | Refer to USP | 10/31/2013 | ||||
| Erythromycin | Tablet | Refer to USP | 12/24/2015 | ||||
| Erythromycin Ethylsuccinate | Suspension | II (Paddle) | 75 | Monobasic Sodium Phosphate, pH 6.8 Buffer with 1% SLS Buffer w/ 1% SLS | 900 | 10, 20, 30, 45 and 60 | 01/27/2004 |
| Erythromycin Ethylsuccinate | 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 Ring | Incubator shaker | 130 | 0.9% Saline | 250 | 1, 9, 16, 17, 18, 19, 45 days | 01/03/2007 |
| Estradiol | Vaginal Tablet | I (Basket) | 40 | Phosphate Buffer, pH 4.75 ± 0.05 | 500 | 1, 2, 3, 5, 8, 10 and 12 hours | 07/21/2009 |
| Estradiol (0.014 mg/24 hr) | Film, Transdermal (Extended Release) | Develop a method to characterize in vitro release | 10/28/2010 | ||||
| Estradiol (0.025 mg/24 hr, 0.0375 mg/24 hr, 0.05 mg/24 hr, 0.06 mg/24 hr, 0.075 mg/24 hr and 0.1 mg/24 hr) | Film, Transdermal (Extended Release) | Develop a method to characterize in vitro release | 10/28/2010 | ||||
| Estradiol (Test 1) (0.025 mg/24 hr, 0.0375 mg/24 hr, 0.05 mg/24 hr, 0.075 mg/24 hr and 0.1 mg/24 hr) | Film, Transdermal (Extended Release) | VI (Cylinder) attach the patch to a disk at the bottom of the cylinder | 50 | Water at 32 ± 0.5°C | 0.025 mg/24 hr and 0.0375 mg/24 hr: 500 mL; 0.05 mg/24 hr, 0.075 mg/24 hr and 0.1 mg/24 hr: 900 mL | 1, 2, 4, 6, 8, 10 and 12 hours | 10/28/2010 |
| Estradiol (Test 2) (0.05 mg/24 hr and 0.1 mg/24 hr) | Film, Transdermal (Extended Release) | V (Paddle over Disk) with a stainless steel disk | 50 | Water at 32 ± 0.5°C | 900 | 6, 12, 18, 24, 36, 48, 60, 72 and 96 hours | 10/28/2010 |
| Estradiol (Test 3) 0.0375 mg/24 hr, 0.05 mg/24 hr, 0.075 mg/24 hr and 0.1 mg/24 hr) | Film, Transdermal (Extended Release) | VI (Cylinder) attach the patch to the cylinder with double-sided tape | 50 | Water at 32 ± 0.5°C | 0.0375 mg/24 hr: 500 mL; 0.05 mg/24 hr, 0.075 mg/24 hr and 0.1 mg/24 hr: 900 mL | 1, 2, 4, 6, 10, 12, 18, 24 and 36 hours | 10/31/2013 |
| Estradiol/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 | Refer to USP | 07/15/2009 | ||||
| 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 Acetate | Tablet | Refer to USP | 07/15/2009 | ||||
| Ethinyl Estradiol/Norethindrone Acetate | Capsule | II (Paddle) | 100 | Phosphate Buffer, pH 6.8, containing 0.07% w/v Triton X 100 | 900 | 5, 10, 20, 30, 45, 60 and 75 | 02/15/2018 |
| Ethinyl Estradiol/Norethindrone Acetate [0.01mg,0.01 mg;1 mg] | Tablet (Chewable) | II (Paddle) | 75 | 0.025 M Na Acetate Buffer with 0.15% Sodium Lauryl Sulfate [SLS] (pH 5.0) [degassed] | 500 | 10, 15, 20, 30 and 45 | 12/24/2015 |
| Ethinyl Estradiol/Norethindrone Acetate [0.02mg;1mg] | Tablet (Chewable) | II (Paddle) | 75 | 0.025 M Sodium Acetate Buffer with 0.15% SLS, pH 5.0 | 600 | 10, 15, 20, 30 and 45 | 02/14/2014 |
| Ethinyl Estradiol/Norgestimate | Tablet | 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 (Extended Release) | Refer to USP | 06/24/2010 | ||||
| Etodolac | Tablet | Refer to USP | 01/14/2008 | ||||
| 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 | Tablet | Refer to USP | 06/18/2007 | ||||
| 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/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 (Micronized) | II (Paddle) | 75 | 0.025 M SLS in water | 1000 | 10, 20, 30, 40 and 60 | 06/03/2008 |
| 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 (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 | Tablet | Refer to USP | 04/14/2016 | ||||
| Fluoxetine HCl | Capsule | Refer to USP | 09/02/2010 | ||||
| Fluoxetine/Olanzapine | Capsule | II (Paddle) | 50 | 0.1 N HCl | 900 | 10, 20, 30 and 45 | 08/17/2006 |
| Fluphenazine HCl | Tablet | Refer to USP | 11/02/2017 | ||||
| Flutamide | Capsule | 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 |
| Fosfomycin Tromethamine | For Suspension | Develop a dissolution method | 07/20/2017 | ||||
| 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 | Tablet | Refer to USP | 07/25/2007 | ||||
| Hydrochlorothiazide | Capsule | I (Basket) | 100 | 0.1 N HCl | 900 | 10, 20, 30 and 45 | 02/03/2004 |
| 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 | 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 | 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/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 | Refer to USP | 07/25/2007 | ||||
| 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 |
| 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 | Tablet (Chewable) | II (Paddle) | 50 | 0.05 M Phosphate Buffer, pH 7.2 | 900 | 10, 20, 30 and 45 | 02/04/2004 |
| Ibuprofen | Tablet | Refer to USP | 07/25/2007 | ||||
| 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 | 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 Potassium | Capsule (Soft-Gelatin/Liquid Fill) | I (Basket) | 150 | Phosphate Buffer, pH 7.2 | 900 | 5, 10, 20 and 30 | 02/04/2004 |
| Ibuprofen Sodium | Capsule | I (Basket) | 150 | Phosphate Buffer, pH 7.2 | 900 | 5, 10, 15, 20 and 30 | 06/25/2015 |
| Ibuprofen/Diphenhydramine | Capsule | I (Basket) | 100 | Phosphate Buffer (200 mM), pH7.2 | 900 | 10, 20, 30 and 45 | 01/03/2007 |
| Ibuprofen/Oxycodone HCl | Tablet | I (Basket) | 100 | Phosphate buffer, pH 7.2 | 500 | 10, 20, 30 and 45 | 04/09/2007 |
| Ibuprofen/Phenylephrine HCl | Tablet | II (Paddle) | 50 | 50 mM Potassium Phosphate Buffer, pH 6.5, (degassed) | 900 | 10, 15, 20, 30 and 45 | 01/05/2012 |
| Ibuprofen/Pseudoephedrine HCl | Capsule | I (Basket) | 150 | Tier 1: 0.05 M phosphate buffer, pH 7.2 Tier 2: 0.05 M phosphate buffer, pH 7.2 with NMT 1750 USP protease units/L of 1 X USP pancreatin | 900 | 10, 20, 30 and 45 | 03/04/2006 |
| Ibuprofen/Pseudoephedrine HCl | Suspension | II (Paddle) | 50 | 0.05 M Phosphate Buffer, pH 7.2 | 900 | 5, 10, 15 and 30 | 02/04/2004 |
| Icosapent Ethyl | Capsule | Develop an in vitro release method using USP IV (Flow-Through Cell), and, if applicable, Apparatus II (Paddle) or any other appropriate pharmacopoeial apparatus, for comparative evaluation by the Agency. | 08/15/2013 | ||||
| Idelalisib | Tablet | II (Paddle) | 75 | 0.01 N HCl | 750 | 5, 10, 15, 20 and 30 | 08/27/2015 |
| Iloperidone | Tablet | II (Paddle) | 50 | 0.1 N HCl | 500 | 5, 10, 15, 30, 45 and 60 | 08/05/2010 |
| Imatinib Mesylate | Tablet | II (Paddle) | 50 | 0.1 N HCl | 1000 | 5, 10, 15, 20 and 30 | 09/22/2011 |
| Imipramine HCl | Tablet | Refer to 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 |
| Ivacaftor/Tezacaftor [FDC: IVA+ TEZ]; Ivacaftor [IVA] | Tablet/Tablet (Copackage) | II (Paddle) with option to use a sinker | FDC: IVA: 65/TEZ:75; IVA: 65 | FDC: IVA: 50 mM Sodium Phosphate Buffer with 0.4% Sodium Dodecyl Sulfate (SDS), pH 6.8/TEZ: 0.2 SDS% in 0.1 N HCl; IVA: 50 mM Sodium Phosphate Buffer with 0.7% SDS, pH 6.8; | FDC: IVA: 900/ TEZ: 900; IVA: 900 | 5, 10, 15, 20, 30 and 45 | 03/07/2019 |
| Ivermectin | Tablet | II (Paddle) | 50 | 0.5% SDS in 0.01 M Monobasic Sodium Phosphate, pH 7.0 | 900 | 10, 20, 30, 45 and 60 | 02/04/2004 |
| 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 | Tablet | Refer to USP | 02/07/2019 | ||||
| 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 | Refer to USP | 11/02/2017 | ||||
| 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 (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 |
| Lamotrigine | Tablet (Extended Release) | Refer to USP | 02/18/2016 | ||||
| Lansoprazole | Capsule (Delayed Release) | Refer to USP | 11/04/2008 | ||||
| Lansoprazole | Tablet (Delayed Release, Orally Disintegrating) | II (Paddle) | 75 | Acid Stage: 0.1 N HCl; Buffer Stage: Phosphate Buffer, pH 6.8 with 5 mM Sodium Dodecyl Sulfate | 500 (Acid), 900 (Buffer) | 60 (Acid), 10, 20, 30 and 45 (Buffer) | 11/04/2008 |
| Lanthanum Carbonate | Chewable Tablet | Reciprocating Cylinder (Apparatus 3 modified) | 10 dpm (dip rate per minute) | 0.25 N HCl | 900 (modified from the standard apparatus 3 vessel to achieve sink condition) | 10, 20, 30 and 45 | 01/03/2007 |
| Lapatinib Ditosylate | Tablet | II (Paddle) | 55 | 2% Polysorbate 80 in 0.1 N HCl | 900 | 10, 15, 30 and 45 | 10/30/2009 |
| 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 |
| Letermovir | Tablet | II (Paddle) | 75 | 25 mM Na Acetate Buffer, pH 4.5 with 0.6% Tween-80 | 900 | 10, 15, 20, 30, 45 and 60 | 02/08/2018 |
| Letrozole | Tablet | Refer to USP | 04/10/2008 | ||||
| Letrozole (LET); Ribociclib Succinate (RIB) | Tablet/Tablet (Copackage) | II (Paddle) | RIB: 50; LET: 75 | RIB: 0.01 N HCl; LET: 0.1 N HCl | RIB: 900; LET: 900 | 5, 10, 15, 20, 30 and 45 | 03/07/2019 |
| Leucovorin Calcium | Tablet | Refer to 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 (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 |
| Levetiracetam | Tablet, for Suspension | II (Paddle) | 50 | Phosphate Buffer, pH 6.8 (degas) | 900 | 2.5, 5, 10, 15 and 20 | 03/02/2017 |
| 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 | Tablet | Refer to USP | 04/10/2008 | ||||
| Lithium Carbonate | Capsule | Refer to USP | 07/25/2007 | ||||
| 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 | Tablet (Combination) | Refer to USP | 01/15/2015 | ||||
| Lopinavir/Ritonavir | Capsule (Soft-Gelatin) | II (Paddle) | 50 | Tier 1: 0.05 M Polyoxyethylene 10 Lauryl Ether with 10 mM Sodium Phosphate monobasic (pH 6.8); Tier II: same as above with NMT 1750 USP units/L of Pancreatin | 900 | 10, 15, 30 and 45 | 06/18/2007 |
| Loratadine | Tablet (Chewable) | II (paddle) | 50 | 0.1 N HCl | 500 | 15, 30, 45 and 60 | 07/14/2008 |
| Loratadine | Tablet (Orally Disintegrating) | I (Basket) | 50 | SGF without enzyme | 900 | 2, 4, 6 and 10 | 07/14/2008 |
| Loratadine | Capsule (Soft-Gelatin) | II (Paddle) with sinker | 75 | Tier I: 0.1N HCl with 0.1% Tween 20. Tier II: 0.1N HCl with 0.1% Tween 20 with addition of pepsin (as per USP). | 900 | 10, 20, 30, 45 and 60 | 02/28/2013 |
| Loratadine/Pseudoephedrine Sulfate (10 mg /240 mg) | Tablet (Extended Release) | I (Basket) | 75 | 900 mL 0.1 N HCl for one hour, then replace the medium with 900 mL 0.05 M phosphate buffer at pH6.8 containing 0.01% sodium lauryl sulfate. | 900 | Loratadine:10, 15, 20, 30 and 45; Pseudoephedrine: 1, 2, 4, 8, 12, 16, 18 and 24 hours | 08/05/2010 |
| Loratadine/Pseudoephedrine Sulfate (5 mg /120 mg) | Tablet (Extended Release) | II (Paddle) | 50 | 900 mL 0.1 N HCl for one hour, then replace with 900 mL 0.05 M phosphate buffer at pH 8.2 containing 0.01% sodium lauryl sulfate | 900 | Loratadine:15, 20, 30, 45, 60 and 90; Pseudoephedrine: 1, 2, 4, 8, 12 and 16 hours | 08/05/2010 |
| Lorazepam | Tablet | Refer to USP | 01/14/2008 | ||||
| Lorcaserin HCl | Tablet (Extended Release) | I (Basket) | 100 | 0.1 N HCl (deaerated) | 900 | 1, 2, 4, 5, 8 12, 16 and 20 hours | 10/20/2016 |
| Lorcaserin HCl | Tablet | II (Paddle) | 50 | 0.1 N HCl (deaerated) | 900 | 5, 10, 15, 20 and 30 | 12/22/2016 |
| Losartan Potassium | Tablet | II (Paddle) | 50 | Water (deaerated) | 900 | 10, 20, 30 and 45 | 02/06/2004 |
| Losartan Potassium | Tablet | Refer to USP | 01/05/2012 | ||||
| Loteprednol Etabonate | Ophthalmic Suspension | Develop a method to characterize in vitro release | 06/30/2016 | ||||
| Loteprednol Etabonate/Tobramycin | Ophthalmic Suspension | Develop a method to characterize in vitro release | 01/31/2013 | ||||
| Lovastatin | Tablet (Extended Release) | II (Paddle) | 50 | 0.5% sodium lauryl sulfate (SLS) / sodium phosphate buffer (0.01M), pH 6.5 | 900 | 1, 2, 4, 6, 8, 12, 16 and 20 hours | 02/07/2019 |
| Lovastatin/Niacin | Tablet (Extended Release) | I (Basket) | 100 | For Niacin: 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 | 0.029 M sodium phosphate buffer w/ 0.5% SDS, pH 7.4 | 900 | 15, 30, 45, and 60 | 02/19/2008 |
| Magnesium Hydroxide/Omeprazole/Sodium Bicarbonate | Tablet (Chewable) | II (Paddle) | 150 | pH 7.4 Phosphate Buffer with 0.5% SDS | 900 | 15, 30, 45, 60 and 90 | 10/06/2008 |
| 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 |
| Mecamylamine HCl | Tablet | Refer to USP | 02/15/2018 | ||||
| Meclizine HCl | Tablet (Chewable) | I (Basket) | 100 | 0.01 N HCl | 900 | 10, 20, 30, 45 and 60 | 04/08/2010 |
| Meclizine HCl | Tablet | I (Basket) | 100 | 0.01 N HCl | 900 | 10, 20, 30, 45 and 60 | 08/27/2009 |
| Medroxyprogesterone Acetate | Tablet | Refer to USP | 12/24/2015 | ||||
| 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 (104mg/0.65ml) | Injectable Suspension | Develop a method to characterize in vitro release | 02/08/2018 | ||||
| Mefenamic Acid | Capsule | Refer to USP | 12/15/2009 | ||||
| Mefloquine HCl | Tablet | I (Basket) | 100 | SGF without enzyme | 900 | 10, 20, 30, 45 and 60 | 02/06/2004 |
| Megestrol Acetate | Oral Suspension | Refer to USP | 12/15/2009 | ||||
| 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 |
| 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 |
| Melphalan | Tablet | Refer to USP | 07/14/2008 | ||||
| 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 |
| 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 |
| 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 | ||||
| Methscopolamine Bromide | Tablet | Refer to USP | 02/15/2018 | ||||
| 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 | Tablet (Extended Release, Orally Disintegrating ) | II (Paddle) | 75 | Acid Stage: 0.1 N HCl; Buffer Stage: Phosphate Buffer, pH 6.8 | Acid Stage: 900 mL; Buffer Stage: 1000 mL | Acid Stage: 15, 30, 60, 120 minutes; Buffer Stage: 1, 2, 3, 4, 6 and 8 hours | 11/16/2017 |
| Methylphenidate | 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 | Refer to USP (provide individual unit data). | |||||
| Methylphenidate HCl | Tablet (Extended Release, Chewable) | II (Paddle) | 75 | 0.4M KH2PO4 solution (degas) | 900 | 0.25, 0.5, 1, 2, 3, 4, 6, 8 hours | 03/17/2016 |
| Methylphenidate HCl | Powder for Suspension (Extended Release) | II (Paddle) | 75 | 0.4 M Phosphate Buffer, pH 4.5 | 900 | 0.25, 0.5, 1, 2, 3, 4, 6 and 8 hours | 06/02/2016 |
| Methylphenidate HCl | Tablet (Chewable) | 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 |
| 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 | Refer to USP | 07/15/2009 | ||||
| Metoclopramide HCl | Tablet (Orally Disintegrating) | I (Basket) | 50 | Water | 900 | 5, 10, 15, 20, 30 and 45 | 04/08/2010 |
| 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 | Capsule | Refer to USP | 12/24/2015 | ||||
| Metronidazole | Capsule | I (Basket) | 100 | 0.1 N HCl | 900 | 10, 20, 30 and 45 | 02/09/2004 |
| Metronidazole | Tablet | Refer to USP | 08/05/2010 | ||||
| Metyrosine | Capsule | Refer to USP | 02/15/2018 | ||||
| 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 |
| Midostaurin | Capsule | II (Paddle) | 50 | Tier 1:Deionized water with 0.5% Polysorbate 20; Tier 2: Deionized water with 0.5% Polysorbate 20 containing pepsin | 900 | 5, 10, 15, 20, 30 and 45 | 11/02/2017 |
| 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 | 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 | 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 | Capsule | Refer to USP | 04/15/2008 | ||||
| Minocycline HCl (135 mg and 105 mg) | Tablet (Extended Release) | I (Basket) | 100 | pH 2.1 Buffer (Degassed) | 900 | 15, 30, 45, 60, 90, 120, 180 and 210 | 11/02/2017 |
| Minoxidil | Tablet | Refer to USP | 04/15/2008 | ||||
| Mirabegron | 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 | II (Paddle) | 50 | 0.5% SDS in water | 900 | 5, 10, 20 and 30 | 04/09/2007 |
| Montelukast Sodium | Tablet (Chewable) | II (Paddle) | 50 | 0.5% SDS in water | 900 | 5, 10, 20 and 30 | 03/04/2006 |
| Morphine Sulfate | Capsule (Extended Release) | Refer to USP | 08/11/2008 | ||||
| Morphine Sulfate | Tablet (Extended Release) | I (Basket) | 100 | Simulated Gastric Fluid [SGF] without enzyme | 900 | 0.25, 0.5, 1, 1.5, 2, 4, 6 and 8 hours | 10/20/2016 |
| Morphine Sulfate | Tablet | II (Paddle) | 50 | Deionized Water | 900 | 5, 15, 20 and 30 | 01/15/2010 |
| 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 | ||||
| Naldemedine | Tablet | II (Paddle) | 50 | Mixture of pH 6.8 phosphate buffer [25 mM disodium hydrogen phosphate] solution and water (1:1) | 500 | 5, 10, 15, 20 and 30 | 11/02/2017 |
| 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 | Suspension | Develop a dissolution method | 11/16/2017 | ||||
| Naproxen Sodium | Tablet | Refer to USP | 10/04/2012 | ||||
| Naproxen Sodium | Capsule | II (Paddle) | 75 | Sodium Phosphate Buffer, pH 7.4 ± 0.05 | 900 | 10, 15, 20, 30 and 45 | 05/28/2015 |
| Naproxen Sodium | 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/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 | Lozenge | I (Basket) | 100 | Phosphate Buffer, pH 7.4 | 900 | 0.5, 1, 2, 3, 6 and 8 hours | 12/23/2010 |
| 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 |
| 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 |
| Niraparib | Capsule | II (Paddle) with sinker | 50 | Tier 1: 0.08M Sodium Acetate Buffer, pH 4.0; Tier 2: 0.08M Sodium Acetate Buffer, pH 4.0 containing pepsin (750,000 units/L) | 900 | 10, 15, 20, 30, 45 and 60 | 11/02/2017 |
| Nisoldipine | Tablet (Extended Release) | II (Paddle) with option to use a sinker | 50 | HCl with SLS (32.5 ± 0.1 g Sodium Lauryl Sulfate in 6489 mL of purified water containing 17.0 mL HCl, pH adjusted to 1.20 ± 0.05 with HCl) | 900 | 1, 4, 8, 12, 15, 18 and 24 hours | 04/02/2009 |
| Nitazoxanide | Tablet | II (Paddle) | 75 | Phosphate buffer at pH 7.5 with 6% hexadecyltrimethyl ammonium bromide, bath temperature at 25ºC | 900 | 10, 20, 30, 45, 60 | 01/03/2007 |
| Nitazoxanide | Oral Suspension | II (Paddle | 100 | Phosphate buffer at pH 7.5 with 6% hexadecyltrimethyl ammonium bromide, bath temperature at 25ºC | 900 | 10, 20, 30, 45 and 60 | 10/21/2010 |
| Nitisinone | Tablet | II (Paddle) | 50 | Phosphate Buffer, pH 6.8 | 2 mg tablets: 500 mL; 5 mg and 10 mg tablets: 900 mL | 10, 15, 20, 30, 45, 60, 75 and 90 | 02/15/2018 |
| Nitisinone | Capsule | II (Paddle) with sinker | 50 | Phosphate Buffer, pH 6.8 | 1000 | 5, 10, 15, 20, 30 and 45 | 11/02/2017 |
| 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 | 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 |
| Nystatin | Tablet | II (Paddle) | 75 | Water with 0.1% SLS | 900 | 15, 30, 45, 60 and 90 | 01/03/2007 |
| Obeticholic Acid | Tablet | II (Paddle) | 75 | 0.08% polysorbate 80 in 50mM sodium phosphate dibasic buffer, pH 6.8 | 900 | 5, 10, 15, 20, 30 and 45 | 11/02/2017 |
| Octreotide 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 | Refer to USP | 11/02/2017 | ||||
| Olsalazine Sodium | Capsule | I (Basket) | 100 | Phosphate Buffer, pH 7.5 | 900 | 10, 20, 30 and 45 | 02/12/2004 |
| 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 (Orally Disintegrating) | OTC Tablet (Delayed Release) | II (Paddle) | 100 | Tablets are pre-exposed to 500 ml of 0.1M HCL for 2 hrs and then 400 ml of 0.235M Na2HP04 is added to the medium. Adjust if necessary with 2 N HCI or 2 N NaOH to a pH of 6.8 | Acid stage: 500; Buffer stage: 900 | Acid stage: 120; Buffer stage: 10, 20, 30, 45 and 60 | 02/08/2018 |
| Omeprazole Magnesium | For suspension (Delayed Release) | II (Paddle) | 100 | Pre-exposed to 300 mL of 0.1M HCl for 2 hrs and then 700 mL of 0.086 M Na2HPO4 is added to the medium to give 1000 mL with pH 6.8 | Acid stage: 300; Buffer stage: 1000 | Acid stage: 120; Buffer stage: 10, 20, 30, 45 and 60 | 02/07/2019 |
| Omeprazole Magnesium | OTC Tablet (Delayed Release) | II (Paddle) | 100 | Tablets are pre-exposed to 300 mL of 0.1M HCL for 2 hrs and then 700 mL of 0.086 M Na2HPO4 is added to the medium containing the capsule to give 1000 mL with pH 6.8 | 300 ml for the acid stage; 1000 ml for the buffer stage | Sampling started at the buffer stage 10, 20, 30, 45 and 60 | 01/03/2007 |
| Omeprazole Sodium Bicarbonate | Capsule | II (Paddle) | 75 | Phosphate Buffer, pH 7.4 | 900 | 15, 30, 45 and 60 | 07/14/2008 |
| Omeprazole Sodium Bicarbonate | Powder for suspension (Immediate Release) | II (Paddle) | 50 | 0.25 mM Sodium Phosphate Buffer, pH 7.4 | 900 | 5, 10, 15, and 30 | 06/20/2007 |
| Ondansetron | Tablet (Orally Disintegrating) | Refer to USP | 06/18/2007 | ||||
| Ondansetron | Film (Oral) | V (Paddle over Disk) with a stainless steel disk (120 mesh screens) | 50 | 0.1 N HCl | 900 | 5, 10, 15, 20 and 30 | 01/26/2012 |
| Ondansetron HCl | Tablet | 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 Suspension | 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 | Suspension | II (Paddle) | 100 | SGF without enzyme | 900 | 10, 20, 30 and 45 | 02/13/2004 |
| Paroxetine HCl | Tablet | Refer to USP | 01/14/2008 | ||||
| Paroxetine Mesylate | Tablet | II (Paddle) | 60 | Simulated Gastric Fluid (SGF) without enzymes | 900 | 5, 10, 15, 20, 30 and 45 | 03/07/2019 |
| 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 | Tablet | II (Paddle) | 50 | 0.1 N HCl | 900 | 5, 10, 15, 20 and 30 | 05/15/2014 |
| 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 |
| 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 (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 | 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/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 | Suspension | Refer to USP | 06/18/2007 | ||||
| Phenytoin | Tablet (Chewable) | Refer to USP | 01/14/2008 | ||||
| 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 |
| Pirfenidone | Tablet | II (Paddle) | 50 | Water | 1000 | 5, 10, 15, 20, 30 and 45 | 03/27/2018 |
| 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 | Tablet (Extended Release) | Refer to USP | 07/25/2007 | ||||
| Potassium Chloride | Capsule (Extended Release) | Refer to USP | 12/24/2015 | ||||
| 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 | Tablet (Extended Release) | II (Paddle) | 50 | 0.06 M HCl | 900 | 1, 2, 4, 6, 8, 10, 12, 16 and 24 hours | 02/08/2018 |
| 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 | Rectal Suppository | Develop a method to characterize in vitro release | 10/20/2016 | ||||
| Promethazine HCl | Tablet | Refer to USP | 07/25/2007 | ||||
| Propafenone HCl | Capsule (Extended Release) | Refer to USP | 11/02/2017 | ||||
| Propafenone HCl | Tablet | Refer to USP | 11/02/2017 | ||||
| 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 | Capsule | II (Paddle) | 50 | 0.1 N HCl | 500 | 10, 20, 30 and 45 | 02/18/2004 |
| Ramipril | Tablet | II (Paddle) | 50 | 0.1 N HCl | 500 | 5, 10, 15 and 30 | 09/03/2008 |
| Ranitidine HCl | Tablet | Refer to USP | 07/25/2007 | ||||
| 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 | ||||
| Ranolazine | Tablet (Extended Release) | Develop a dissolution method | 02/07/2019 | ||||
| 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 |
| Ribociclib | Tablet | II (Paddle) | 50 | 0.01N HCl (Degassed) | 900 | 10, 15, 20, 30, 45 and 60 | 11/02/2017 |
| 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 | Refer to USP | 07/01/2010 | ||||
| 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/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 | ||||
| Ritonavir | Powder | I (Basket -100 mesh) | 100 | 0.1 N HCl | 900 | 5, 10, 15, 20 and 30 | 11/16/2017 |
| Rivaroxaban (10 mg) | Tablet | II (Paddle) | 75 | Acetate Buffer pH 4.5, 0.2% sodium dodecyl sulfate (SDS) | 900 | 10, 15, 20, 30 and 45 | 01/15/2015 |
| Rivaroxaban (15 and 20 mg) | Tablet | II (Paddle) | 75 | Acetate Buffer pH 4.5, 0.4% SDS | 900 | 10, 15, 20, 30 and 45 | 01/15/2015 |
| Rivaroxaban (2.5 mg) | Tablet | II (Paddle) | 75 | Acetate Buffer pH 4.5 | 900 | 10, 15, 20, 30 and 45 | 02/07/2019 |
| Rivastigmine | Film, Transdermal | Modified USP Type VI (cylinder) | 50 | 0. 9 % NaCl at 32º C | 500 | 1, 2, 4, 7, 9 and 12 hours | 06/10/2009 |
| Rivastigmine Tartrate | Capsule | 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 | Refer to USP | 05/15/2014 | ||||
| Ropinirole HCl | Tablet (Extended Release) | II (Paddle) | 100 | pH 4.0 Citrate-THAM Buffer | 500 | 1, 2, 4, 6, 8, 12, 16, 20 and 24 hours | 08/27/2009 |
| 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 |
| Safinamide Mesylate | Tablet | II (Paddle) | 100 | 0.1 N HCL with Sodium Chloride [2% (wt/vol) solution], pH 1.2 | 900 | 5, 10, 15, 30, 45 and 60 | 11/02/2017 |
| 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 |
| Secnidazole | Granule | I (Basket) | 50 | Phosphate Buffer, pH 6.8 | 900 | 0.5, 1, 1.5, 2, 2.5, 3, 3.5 and 4 hours | 11/16/2017 |
| Selegiline HCl | Capsule | Refer to 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 | Tablet (Orally Disintegrating) | II (Paddle) | 75 | 0.15% SDS Buffer, pH 6.8 | 900 | 5, 10, 15 and 30 | 09/03/2008 |
| Simvastatin | Tablet | Refer to USP | 06/18/2007 | ||||
| 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 |
| 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 (Chewable) | II (Paddle) | 50 | 0.1 N HCl | 900 | 10, 15, 20, 30, 45 and 60 | 11/02/2017 |
| Sulfadiazine | Tablet | Refer to USP | 07/14/2008 | ||||
| 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 |
| Sulfamethoxazole/Trimethoprim | Tablet | Refer to USP | 01/14/2008 | ||||
| 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 | Capsule | II (Paddle) | 50 | Hydroxypropyl Cellulose Solution (1 in 20,000). Adjust to pH 4.5 by Phosphoric Acid | 900 | 30, 60, 90 and 120 | 02/20/2004 |
| Tacrolimus | Tablet (Extended Release) | II (Paddle) | 100 | 0.005% HPC in Water with 0.50% SLS adjusted to pH 4.5 | 900 | 0.5, 1, 2.5, 4.5, 6.5, 8.5 and 12 hours | 06/30/2016 |
| Tadalafil | Tablet | II (Paddle) | 50 | 0.5% Sodium Lauryl Sulfate | 1000 | 10, 20, 30 and 45 | 01/26/2006 |
| 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 | I (Basket) | 75 | 0.1 N HCl | 900 | 10, 20, 30, 45 and 60 | 10/28/2010 |
| Tapentadol HCl | Tablet (Extended Release) | II (Paddle) with sinker | 100 | 0.05 M Phosphate Buffer of pH 6.8, Simulated intestinal fluid (without enzyme) | 900 | 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours | 10/31/2013 |
| Tasimelteon | Capsule | 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 | Powder for Oral | II (Paddle) | 100 | 0.2% polysorbate 80 in 0.01 M HCl | 900 | 10, 20, 30, 45, 60 and 75 | 01/31/2013 |
| Tenofovir Disoproxil Fumarate | Tablet | II (Paddle) | 50 | 0.1 N HCl | 900 | 10, 20, 30, and 45 | 01/03/2007 |
| 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 | Film, Transdermal (Extended Release) | V (Paddle over disk). Paddle 25 mm above the film on the disk. | 50 | 0.1 M sodium chloride containing 2.5% (v/v) of Tween 40 at 32 ± 0.5°C. Delivery surface faces upwards towards the media. | 900 | 1, 3, 5, 7, 11, 16, 20 and 24 hours | 06/30/2011 |
| Testosterone | 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 |
| 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 |
| Tipiracil HCl/Trifluridine | Tablet | II (Paddle) | 50 | 0.1 N HCl | 900 | 5, 10, 15, 20 and 30 | 11/02/2017 |
| Tipranavir | Capsule | II (Paddle) | 50 | 0.05 M phosphate buffer pH 6.8 | 900 | 15, 30, 45 and 60 | 12/03/2007 |
| 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 | Capsule (Extended Release) | I (Basket) | 100 | Phosphate buffer (pH 6.8) | 900 | 1, 3, 7 hours | 06/18/2007 |
| Tolterodine Tartrate | Tablet | II (Paddle) | 50 | SGF without enzymes, pH 1.2 | 900 | 5, 10, 15 and 30 | 02/20/2004 |
| 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 | 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 |
| Topiramate | Tablet | II (Paddle) | 50 | Water (deaerated) | 900 | 5, 10, 20 and 30 | 02/19/2004 |
| 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 | Intra-Articular, For Suspension (Extended Release) | II (Paddle) | 75 | 0.3% SDS in 10 mM phosphate buffer, pH 7.2 + 0.02% sodium azide @35°C | 1000 | 1, 2, 4, 8, 12, 16, 24, 36, 48, 72, 96 and 120 hours | 02/08/2018 |
| 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 | For Intramuscular Suspension (Extended Release) | II (Paddle) | 75 | 50 mL of methanol to 950 mL of water | 950 | 1, 8, 24, 96, and 168 hours | 11/16/2017 |
| Triptorelin Pamoate | Injectable Suspension | II (Paddle) | 200 | Water-Methanol (95:5); Reconstitute vial in 2 mL Water for Injection, add to 500 mL medium at 37°C | 500 | 1, 6, 12, 24, 48 and 72 hours | 07/14/2008 |
| Trospium Chloride | Capsule (Extended Release) | II (Paddle) with sinker | 50 | 0.1 N HCl, pH 1.1 for 2 hrs and then add 200 mL of 0.1 N NaOH in 200 mM Phosphate Buffer. Adjust pH to 7.5 using 2 N HCl and/or 2N NaOH | 0-2 hrs: 750 ml, After 2 hrs: 950 ml. | 2, 3, 4, 6, 8, 12 and 16 hours | 07/15/2010 |
| Trospium Chloride | Tablet | 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 |
| Valbenazine | Capsule | II (Paddle) with sinker | 50 | Tier 1: 0.1N HCl; Tier 2: 0.1N HCl containing pepsin (750,000 units per 1000 mL) | 900 | 5, 10, 15, 20 and 30 | 11/02/2017 |
| Valganciclovir HCl | Tablet | Refer to 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) | 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 | Tablet | II (Paddle) | 50 | Water (deaerated) | 900 | 5, 10, 15 and 30 | 02/19/2004 |
| 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 | Capsule (Extended Release) | I (Basket) | 100 | Water | 900 | 2, 4, 8, 12 and 20 hours | 01/03/2007 |
| Verapamil HCl | Tablet (Extended Release) | Refer to USP | 06/24/2010 | ||||
| Verapamil HCl | Capsule (Extended Release) | Refer to USP | 08/27/2015 | ||||
| Verapamil HCl | Tablet | Refer to USP | 11/04/2008 | ||||
| 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 (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 |
| Zileuton | Tablet | II (Paddle) | 50 | 0.05 M SLS in water | 900 | 10, 20, 30, 45 and 60 | 02/19/2004 |
| 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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