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Dissolution Methods for Drug Products

List of all Drugs in the Database

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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/Lamivudine Tablet  II (Paddle)  75  0.1 N HCl  900  10, 20, 30, and 45   01/03/2007 
Abacavir Sulfate/Lamivudine/Zidovudine Tablet  II (Paddle)  75  0.1 N HCl  900  5, 10, 15, 30, and 45  01/03/2007 
Acamprosate Calcium Tablet (Delayed Release)  I (Basket)  180  Acid Stage: 0.1 N HCl Buffer Stage: "Citrate-sodium hydroxide" buffer pH 6.8 (150 ml of 2N NaOH, 21.014 gm of citric acid and ultra-pure water to 1000 ml) (Method B)  1000  120 (Acid) 30, 60, 90, 120, and 180 (buffer)  12/20/2005 
Acarbose Tablet  II (Paddle)  75  Water (deaerated)  900  10, 15, 20, 30 and 45  03/22/2006 
Acetaminophen Suppository  II (Paddle)  50  Phosphate buffer, pH 5  900  15, 30, 45, 60 and 90  08/17/2006 
Acetaminophen/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)  900  10, 20, 30, 45 and 60  03/04/2006 
Acetaminophen/Caffeine/Dihydrocodeine Bitartrate Capsule  I (Basket)  100  Water  900  10, 20, 30, 45 and 60  01/03/2007 
Acetaminophen/Caffeine/Dihydrocodeine Bitartrate Tablet  II (Paddle)  50  Water  900  10, 15, 30, 45, and 60  07/25/2007 
Acetaminophen/Hydrocodone Bitartrate Tablet      Refer to USP      07/25/2007 
Acetaminophen/Oxycodone Tablet      Refer to USP      01/14/2008 
Acetaminophen/Pentazocine HCl Tablet  I (Basket)  100  Water (deaerated)  900  10, 20, 30, 45 and 60  01/12/2004 
Acetaminophen/Tramadol HCl Tablet  II (Paddle)  50  0.1 N HCl  900  5, 10, 15, 20 and 30  03/04/2006 
Acetazolomide Tablet      Refer to USP      07/14/2008 
Acitretin Capsule  I (Basket)  100  3% SLS in water, pH 9.6  900  10, 20, 30 and 45  01/12/2004 
Acrivastine/Pseudoephedrine HCl Capsule  II (Paddle)  50  0.01 N HCl  900  5, 10, 15 and 30  01/12/2004 
Acyclovir Suspension  II (Paddle)  50  0.1 N HCl  900  10, 20, 30, 45 and 60  02/20/2004 
Acyclovir Tablet      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 
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, and 9 hours  04/09/2007 
Alendronate Sodium Tablet      Refer to USP      01/14/2008 
Alendronate Sodium/Cholecalciferol Tablet  II (Paddle)  For Alendronate: 50; For Cholecalciferol: 75  For Alendronate: Deaerated Water; For Cholecalciferol: 0.3% SDS in USP Water  For Alendronate: 900; For Cholecalciferol: 500  10, 15, 20, 30 and 45  11/25/2008 
Alfuzosin HCl Tablet (Extended Release)  II (Paddle)  100  0.01 N HCl  900  1, 2, 12, 20 hours  06/18/2007 
Aliskiren Hemifumarate Tablet  I (Basket)  100  0.01 N HCl  500  10, 20, 30 and 45  09/03/2008 
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 
Alosetron HCl Tablet  II (Paddle)  50 (for 1 mg) & 75 (for 0.5 mg)  Water (deaerated)  500  10, 20, 30 and 45  01/26/2006 
Alprazolam Tablet (Extended Release)  I (Basket)  100  1% Phosphate Buffer, pH 6.0  500  1, 4, 8, and 16 hours  02/08/2007 
Alprazolam Tablet (Orally Disintegrating)  II (Paddle)  50  70 mM Potassium Phosphate Buffer, pH 6.0  500  2, 5, 10, 15 and 20  10/06/2008 
Alprazolam Tablet      Refer to USP      06/18/2007 
Amantadine HCl Tablet  II (Paddle)  50  Water (deaerated)  500  10, 20, 30, 45 and 60  01/12/2004 
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 M HCl  500  5, 10, 15 and 20  10/06/2008 
Amlodipine Besylate/Benazepril HCl Capsule  I (Basket)  100  0.01 N HCl  500  10, 20 , 30, 45, and 60  06/20/2007 
Amlodipine Besylate/Olmesartan Medoxomil Tablet  II (Paddle)  50  Phosphate Buffer, pH 6.8  900  10, 20, 30 and 45  08/11/2008 
Amlodipine Besylate/Valsartan Tablet  II (Paddle)  50  For Amlodipine: 0.1 N HCl, pH 1.0. For Valsartan: 0.067 M Phosphate Buffer, pH 6.8  900 (for both Amlodipine and Valsartan)  10, 15, 30, and 45  02/19/2008 
Amoxicillin/Clavulanate Potassium Tablet (Chewable)      Refer to USP      01/14/2008 
Amoxicillin/Clavulanate Potassium Suspension  II (Paddle)  75  Water (deaerated)  900  5, 10, 15 and 30  01/14/2004 
Amphetamine Aspartate/Amphetamine Sulfate/Dextroamphetamine Saccharate/Dextroamphetamine Sulfate Tablet  I (Basket)  100  Deionized Water  500  10, 20, 30 and 45  11/25/2008 
Amphetamine Aspartate/Amphetamine Sulfate/Dextroamphetamine Saccharate/Dextroamphetamine Sulfate Capsule (Extended Release)  II (Paddle)  50  Dilute HCl, pH 1.1 for first 2 hrs, then add 200 mL of 200 mM Phosphate Buffer and adjust to pH 6.0 for the remainder  0-2 hrs: 750 mL. After 2 hrs: 950 mL  0.5, 1, 2, 3, and 4 hours  07/25/2007 
Amphetamine ER Capsule  II (Paddle)  50  750 ml of dilute HCl, pH 1.1 for the first 2 hours, then add 200 ml of 200 mM phosphate buffer, and adjust to pH 6 (w/ HCl or NaOH) for the remainder  750 ml of dilute HCl, 200 ml of phosphate buffer  1, 2, 3, 4, and 6 hours  08/17/2006 
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 
Aprepitant Capsule  II (Paddle)  100  2.2% sodium dodecyl sulfate in distilled water  900  10, 15, 20, 30 and 45  01/20/2006 
Aripiprazole Tablet  II (Paddle)  60  pH 1.2 USP Buffer (Hydrochloric Acid)  900  10, 20, 30 and 45  12/20/2005 
Aripiprazole Tablet (Orally Disintegrating)  II (Paddle)  75  Acetate Buffer, pH 4.0  1000  10, 20, 30 and 45  08/11/2008 
Armodafinil Tablet  II (Paddle)  50  0.1 N HCl  900  10, 20, 30 and 45  01/14/2008 
Aspirin/Caffeine/Orphenadrine Citrate Tablet  I (Basket)  75  Water (deaerated)  900  10, 20, 30, 45 and 60  01/15/2004 
Aspirin/Dipyridamole Capsule  I (Basket)  100  0.01 N HCl for first hour, 0.1 M Phosphate Buffer, pH 5.5, thereafter  0-1 hrs: 900 mL. 900 mL thereafter  Acid: 10, 20, 30, 45, and 60 min; Buffer:1, 2, 5, and 7 hrs  10/09/2007 
Aspirin/Hydrocodone Bitartrate Tablet  II (Paddle)  75  Acetate Buffer, pH 4.5  900  10, 20, 30, 45, 60 and 90  01/15/2004 
Aspirin/Meprobamate Tablet  I (Basket)  100  Water (deaerated)  900  10, 20, 30, 45, 60 and 90  01/15/2004 
Aspirin/Methocarbamol Tablet  II (Paddle)  50  Water (deaerated)  900  10, 20, 30, 45, 60 and 90  01/15/2004 
Atazanavir Sulfate Capsule  II (Paddle)  50  0.025 N HCl  1000  10, 20, 30 and 45  01/20/2006 
Atenolol Tablet      Refer to USP      07/25/2007 
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 
Atovaquone Tablet  II (Paddle)  50  40% isopropanol buffered to pH 8.0 with potassium dihydrogen phosphate  900  10, 20, 30, 45, 60 and 90  06/18/2007 
Atovaquone/Proguanil HCl Tablet  II (paddle) with PEAK vessels  50  40% isopropranol buffered to pH 8.0 with potassium dihydrogen phosphate  900  15, 30, 45 and 60  08/17/2006 
Auranofin Capsule  II (Paddle)  50  Water (deaerated)  900  10, 20, 30, and 45  01/15/2004 
Azacitidine Injectable Suspension      Develop a dissolution method      09/03/2008 
Azithromycin Tablet  II (Paddle)  75  0.1 M Phosphate Buffer, pH 6.0  900  10, 20, 30 and 45  01/14/2008 
Azithromycin Suspension (Extended Release)  II (Paddle)  50  Phosphate Buffer, pH 6.0  900  15, 30, 45, 60, 120 and 180  04/15/2008 
Azithromycin Oral Suspension  II (Paddle)  50  Phosphate buffer, pH 6.0  900  10, 20, 30, and 45  08/17/2006 
Baclofen Tablet (Orally Disintegrating)  II (Paddle)  25  50 mM Acetate Buffer, pH 4.5  500 mL (10 mg) or 1000 mL (20mg)  5, 10, 15 and 30  07/14/2008 
Balsalazide Disodium Capsule  II (Paddle) with sinker  50  pH 6.8 buffer  900  10, 20, 30, and 45  01/26/2006 
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       
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 
Bethanechol Chloride Tablet      Refer to USP      10/06/2008 
Bexarotene Capsule  II (Paddle)  50  Tier 1 Medium: 0.5% HDTMA in 0.05 M phosphate buffer, pH 7.5 Tier 2 Medium: 0.5% HDTMA in 0.05 M phosphate buffer, pH 7.5 with 0.05 g/L pancreatin enzyme  900  15, 30, 45 and 60  08/17/2006 
Bicalutamide Tablet  II (Paddle)  50  1% SLS in water  1000  10, 20, 30, 45 and 60  12/15/2005 
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 
Bromocriptine Mesylate Tablet      Refer to USP      07/25/2007 
Bumetanide Tablet      Refer to USP      07/14/2008 
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 
Bupropion HCl Tablet (Extended Release)      Refer to USP      07/25/2007 
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 
Calcitriol Capsule      Develop a quantitative rupture test      06/03/2008 
Calcium Acetate Tablet      Refer to USP      01/14/2008 
Candesartan Cilexetil 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, 32/25 mg) Tablet  II (Paddle)  50  0.35% Polysorbate 20 in phosphate buffer pH 6.5  900  10, 20, 30, 45, and 60  07/14/2008 
Candesartan Cilexetil/Hydrochlorothiazide (32/12.5 mg) Tablet  II (Paddle)  50  0.70% Polysorbate 20 in phosphate buffer pH 6.5  900  15, 20, 30, 45 and 60  07/14/2008 
Capecitabine Tablet  II (Paddle)  50  Water (deaerated)  900  10, 20, 30 and 45  01/23/2004 
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 with 1.8% B-cyclodextrin. After 4 hours: 50 mM Phosphate Buffer, pH 7.5 with 1.1% B-cyclodextrin.  First 4 h: 600 mL. After 4 h: 1000 mL  1, 2, 4, 8, and 10 hours  07/25/2007 
Carbamazepine Tablet (Extended Release)      Refer to USP      01/14/2008 
Carbidopa/Entacapone/Levodopa Tablet  I (Basket)  Carbidopa and Levodopa: 50; Entacapone: 125  For both Carbidopa and Levodopa: 0.1 N HCl, For Entacapone: Phosphate buffer pH 5.5  Carbidopa and Levodopa: 750 ml. Entacapone: 900 ml  10, 20, 30, 45 and 60  01/03/2007 
Carbidopa/Levodopa Tablet      Refer to USP      01/14/2008 
Carbidopa/Levodopa Tablet (Orally Disintegrating)  II (Paddle)  50  0.1 N HCl  750  5, 10, 15, 30, and 45  07/25/2007 
Carvedilol Tablet  II (Paddle)  50  SGF without enzyme  900  10, 20, 30 and 45  01/21/2004 
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  02/09/2006 
Cefixime Suspension  II (Paddle)  50  0.05 M Phosphate buffer, pH 7.2  900  10, 20, 30, and 45  04/09/2007 
Cefpodoxime Proxetil Suspension  II (Paddle)  50  Glycine buffer (0.04 M) pH 3.0  900  10, 20, 30 and 45  12/20/2005 
Cefpodoxime Proxetil Tablet      Refer to USP      07/25/2007 
Cefprozil Tablet      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, 180 mL of SLS solution and 70 mL of 1.2 N NaOH are added to initial medium.Tier 2 Final Medium: 1% SLS, pH 12   Tier 1: 1000 ml Tier 2: 750 ml (initial) 1000ml (final)   15, 30, 45 and 60  10/06/2008 
Cephalexin Suspension  II (Paddle)  25  Water  900  5, 10, 20, and 30  07/25/2007 
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  0.1N HCl  900  5, 10, 15, and 30  01/26/2006 
Chlorambucil Tablet  II (Paddle)  75  0.1N HCl  900  10, 20, 30, and 45   08/17/2006 
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/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/Hydrocodone Plistirex Capsule (Extended Release)  II (Paddle)  50  Simulated Intestinal Fluid without enzyme  500  1, 4, 12, and 24 hours  11/25/2008 
Chlorthalidone Tablet      Refer to USP      04/15/2008 
Chlorzoxazone Tablet      Refer to USP      01/14/2008 
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 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/Ciprofloxacin HCl (AB) Tablet (Extended Release)  II (Paddle)  50  0.1 N HCl  900  15, 30, 60, and 120  01/14/2008 
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 Suspension  II (Paddle)  50  0.05 M Phosphate Buffer, pH 6.8  900  10, 20, 30, 45 and 60  01/23/2004 
Clarithromycin Tablet (Extended Release)      Refer to USP  900    10/06/2008 
Clarithromycin Tablet      Refer to USP      07/25/2007 
Clonazepam Tablet (Orally Disintegrating)  II (Paddle)  50  Water  900  5, 10, 15, 30, and 45  07/25/2007 
Clonidine HCl Tablet      Refer to USP      06/18/2007 
Clopidogrel Bisulfate Tablet      Refer to USP      07/25/2007 
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 
Cyclobenzaprine Capsule (Extended Release)  II (Paddle)  50  0.1 N HCl  900  2, 4, 6, 8, 12, and 16 hours  09/03/2008 
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 
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 
Cyclosporine (25 mg) (AB1) Capsule (Liquid filled)  II (Paddle)  75  0.1 N HCl containing 4 mg of N,N-dimethydodecylamine-N-oxide per mL  500  10, 20, 30, 45, 60 and 90  01/14/2008 
Cysteamine Bitartrate Capsule  I (Basket)  75  0.1 N HCl  900  10, 20, 30 and 45  01/24/2004 
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 
Darifenacin Hydrobromide Tablet (Extended Release)  I (Basket)  100  0.01M HCl Comparative dissolution data should also be provided in 900 ml pH 4.5 buffer, pH 6.8 buffer, and water using Apparatus I (Basket) at 100 RPM.  900  1, 4, 8, 12, 16, 20 and 24 hours  01/20/2006 
Darunavir Ethanolate Tablet  II (Paddle)  75  2% Tween-20 in 0.05 M Sodium Phosphate Buffer, pH 3.0  900  10, 20, 30, and 45   09/13/2007 
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 
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 
Desloratadine Tablet (Orally Disintegrating)  II (Paddle)  50  0.1 N HCl  900  3, 6, 10, 15  06/18/2007 
Desloratadine Tablet  II (Paddle)  50  0.1 N HCl  500  15, 20, 30 and 45  03/04/2006 
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 
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 
Dextromethophan HBr/Guaifenesin Tablet (Extended Release)  I (Basket)  50  0.01 N HCl  900  1, 2, 6, and 12 hours  11/25/2008 
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 
Diclofenac Potassium Tablet  II (Paddle)  50  SIF without enzyme  900  10, 20, 30, 45, 60 and 90  01/27/2004 
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 
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 
Diphenhydramine Citrate/Ibuprofen Tablet  II (Paddle)  50  50 mM Phosphate Buffer, pH 6.5  900  10, 20, 30 and 45  01/14/2008 
Diphenhydramine Hydrochloride/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)  II (Paddle)  100  Acid phase: 0.1 N HCl for 45 minutes; Drug Release: 0.05 M Phosphate Buffer with 75 mM SDS after 45 minutes  Acid phase:500 mL; Drug release: 900 mL  3, 9, 12, 21 hours  06/18/2007 
Divalproex Sodium Tablet (Delayed Release)      Refer to USP      07/25/2007 
Divalproex Sodium Capsule (Delayed Release Pellet)  II (Paddle)  50  0.05 M Phosphate Buffer, pH 7.5  500  2, 4, 6, 8 and 10 hrs  10/06/2008 
Dofetilide Capsule  I (Basket)  100  0.001 M HCL  900  10, 15, 30 and 45  01/20/2006 
Donepezil HCl Tablet (Orally Disintegrating (ODT))  II (Paddle)  50  0.1 N HCl  900  10, 20, 30 and 45  03/04/2006 
Donepezil HCl Tablet  II (Paddle)  50  0.1 N HCl  900  10, 20, 30 and 40  01/27/2004 
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  4, 8, 16 hours  01/03/2007 
Doxercalciferol Capsule      Develop a quantitative rupture test      06/03/2008 
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  750 in acid stage, 950 ml in basic stage  1, 2, 2.5 , 3 and 4 hours  10/06/2008 
Doxycycline Tablet  II (Paddle)  75  0.01 N HCl  900  15, 30, 45, 60 and 90  01/14/2008 
Doxycycline Hyclate Capsule      Refer to USP      07/14/2008 
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 
Drospirenone/Estradiol Tablet  II (Paddle)  50  Water  900  10, 20, 30, and 45  01/03/2007 
Duloxetine HCl Capsule (Delayed Release Pellets)  I (basket)  100  [A] Gastric Challenge: 0.1N HCl [B] Buffer Medium: pH 6.8 phosphate buffer (USP)  1000  120 minutes (For A) 15, 30, 45, 60 and 90 minutes (For B)  03/22/2006 
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 (1.6 g/L, label activity 1:3,000) (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  01/26/2006 
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 
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/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 
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 
Erlotinib HCl Tablet  II (paddle)  75  0.1 N HCl containing 1% SDS  1000  15, 30, 45 and 60  03/22/2006 
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 
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 
Esomeprazole Magnesium Capsule (Delayed Release Pellets)  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: 60, 90 and 120; Buffer stage: 10, 20, 30, 45 and 60  02/26/2004 
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/norgestimate (1mg/0.09mg) Tablet  II (Paddle)  50  0.3% SLS in water  500  10, 20, 30 and 45  07/09/2004 
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 
Ethambutol HCl Tablet      Refer to USP      01/14/2008 
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/Levonorgestrel Tablet      Refer to USP      02/19/2008 
Ethinyl Estradiol/Levonorgestrel (AB) Tablet      Refer to USP      02/19/2008 
Ethinyl Estradiol/Levonorgestrel (AB2) Tablet      Refer to USP      11/04/2008 
Ethinyl Estradiol/Norethindrone Tablet (Chewable)  II (Paddle)  75  0.09% Sodium Lauryl Sulfate in 0.1 N HCl  500  10, 20, 30 and 45  01/14/2008 
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 
Ethosuximide Capsule      Refer to USP      04/15/2008 
Etidronate Disodium Tablet      Refer to USP      06/18/2007 
Etodolac Tablet      Refer to USP      01/14/2008 
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  0.01M Sodium Phosphate, pH 7.0/0.5% SDS  900  5, 10, 20, and 30  01/03/2007 
Famciclovir Tablet  II (Paddle)  50  0.1 N HCl  900  10, 20, 30, and 45  04/09/2007 
Famotidine Suspension  II (Paddle)  25 and 50  0.1 M Phosphate buffer, pH 4.5  900  10, 15, 30 and 45  11/25/2008 
Famotidine Tablet (Orally Disintegrating)  II (Paddle)  50  0.1 M Phosphate Buffer, pH 4.5   900  2, 5, 10, 15 and 20   10/06/2008 
Famotidine Tablet (Chewable)  II (Paddle)  50  0.1 M Phosphate Buffer, pH 4.5  900  10, 20, 30, 45 and 60  01/29/2004 
Famotidine Tablet      Refer to USP      06/18/2007 
Famotidine/Calcium Carbonate/Magnesium Hydroxide Tablet (Chewable)  III (20 mesh top screen, 40 mesh bottom screen)  30 DPM  0.1 M Na Acetate Buffer, pH 4.5   900  10, 20, 30 and 45  12/19/2008 
Felbamate Suspension  II (Paddle)  50  Water (deaerated)  900  5, 10, 15 and 30  01/28/2004 
Felbamate Tablet  II (Paddle)  50  Water (deaerated)  900  10, 20, 30, 45, 60 and 90  01/28/2004 
Felodipine Tablet (Extended Release)      Refer to USP      01/14/2008 
Fenofibrate Tablet  II (Paddle)  50  0.05 M SLS in water  1000  10, 20, 30 and 45  01/29/2004 
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  15, 30, 45 and 60  10/06/2008 
Fenoprofen Calcium Capsule      Refer to USP      11/25/2008 
Fexofenadine HCl Suspension  II (Paddle)  50  0.001 M 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 
Finasteride Tablet      Refer to USP      07/25/2007 
Flavoxate HCl Tablet  I (Basket)  100  0.1 N HCl  900  5, 10, 20 and 30  01/29/2004 
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 
Fluoxetine Capsules (Delayed Release)      Refer to USP      07/25/2007 
Fluoxetine HCl Tablet  I (Basket)  100  0.1 N HCl  1000  5, 10, 15 and 30  01/03/2007 
Fluoxetine/Olanzapine Capsule  II (Paddle)  50  0.1 N HCl  900  10, 20, 30 and 45  08/17/2006 
Fluvastatin Sodium Capsule      Refer to USP      01/14/2008 
Fluvastatin sodium Tablet (Extended Release)  I (Basket)  50  Water  900  0.5, 2, 4, 8 hours  06/18/2007 
Fluvoxamine Maleate Tablet  II (Paddle)  50  Water (deaerated)  900  10, 20, 30, and 45   01/03/2007 
Fosamprenavir Calcium Tablet  II (Paddle)  75  250 mM Sodium Acetate/Acetic acid buffer pH 3.5  900  10, 20, 30 and 45  12/16/2005 
Fosamprenavir Calcium Oral Suspension  II (Paddle)  25  10 mM HCl  900  5, 10,15, and 20  12/03/2007 
Fosinopril Sodium Tablet  II (Paddle)  50  Water (deaerated)  900  10, 20, 30 and 45  01/30/2004 
Fosinopril Sodium/Hydrochlorothiazide Tablet      Refer to USP      08/11/2008 
Frovatriptan succinate Tablet  II (Paddle)  50  Phosphate Buffer pH 5.5  900  5, 10, 15, 20 and 30  11/04/2008 
Gabapentin Tablet      Refer to USP      06/03/2008 
Gabapentin Capsule      Refer to USP      06/03/2008 
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 
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/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/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 HCl Tablet  II (Paddle)  50  Phosphate buffer, pH 6.5  500  10, 20, 30, 45 and 60  06/05/2006 
Griseofulvin Suspension  II (Paddle)  50  0.54% SLS  1000  10, 20, 30, and 45  04/09/2007 
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 
Haloperidol Tablet      Refer to USP      11/25/2008 
Homatropine Methylbromide/Hydrocodone Bitartrate Tablet  II (Paddle)  50  Water (deaerated)  900  10, 20, 30 and 45  02/03/2004 
Hydralazine HCl Tablet      Refer to USP      04/10/2008 
Hydrochlorothiazide Capsule  I (Basket)  100  0.1 N HCl  900  10, 20, 30 and 45  02/03/2004 
Hydrochlorothiazide Tablet      Refer to USP      07/25/2007 
Hydrochlorothiazide/Irbesartan Tablet  II (Paddle)  50  0.1 N HCl  1000  10, 20, 30 and 45  09/24/2008 
Hydrochlorothiazide/Lisinopril Tablet  II (Paddle)  50  0.1 N HCl  900  10, 20, 30, 45 and 60  02/03/2004 
Hydrochlorothiazide/Losartan Potassium Tablet  I (Basket)  100  Water (deaerated)  900  10, 20, 30, 45 and 60  02/03/2004 
Hydrochlorothiazide/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/Telmisartan Tablet  II (Paddle)  75  Phosphate Buffer, pH 7.5  900  10, 15, 20, 30, 45, and 60  04/10/2008 
Hydrochlorothiazide/Valsartan Tablet  II (Paddle)  50  Phosphate Buffer pH 6.8  1000  10, 20, 30 and 45  02/03/2004 
Hydrochlorothizide/Triamterene Capsule      Refer to USP      10/06/2008 
Hydrocodone Bitartrate/Ibuprofen Tablet  II (Paddle)  50  Phosphate Buffer, pH 7.2  900  5, 10, 15 and 30  02/04/2004 
Hydromorphone HCl Tablet      Refer to USP      07/25/2007 
Hydroxyurea Capsule      Refer to USP      09/03/2008 
Hydroxyzine HCl Tablet      Refer to USP      07/25/2007 
Ibandronate Sodium Tablet  II (Paddle)  50  Water  500  5, 10, 15, 30, and 45  01/03/2007 
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 Tablet      Refer to USP      07/25/2007 
Ibuprofen (Chewable Tab) Tablet (Chewable)  II (Paddle)  50  0.05 M Phosphate Buffer, pH 7.2  900  10, 20, 30 and 45  02/04/2004 
Ibuprofen Potassium (Soft gelatin Cap Gel---Liquid Filled) Capsule (Soft Gelatin/Liquid Fill)  I (Basket)  150  Phosphate Buffer, pH 7.2  900  5, 10, 20 and 30  02/04/2004 
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/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 
Imatinib Mesylate Tablet  II (Paddle)  50  0.01 N HCl  1000    11/25/2008 
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 
Irbesartan Tablet      Refer to USP      08/11/2008 
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 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, 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 
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 
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 
Lamivudine (for 100 mg & 150 mg) Tablet  II (Paddle)  50  Water (deaerated)  900  10, 20, 30 and 45  03/22/2006 
Lamivudine (for 300 mg only) Tablet  II (Paddle)  75  0.1 N HCl  900  5, 10, 15 and 30  03/22/2006 
Lamivudine 150 mg/Zidovudine 300mg Tablets and Abacavir Sulfate 300 mg Tablets-co-packaged Tablet  II (Paddle)  75  0.1 N HCl  900  5, 10, 15, 20, 30, 40  01/03/2007 
Lamivudine/Stavudine/Nevirapine Tablet  II (Paddle)  75  0.1 N HCl  900  10, 20, 30, 45 and 60  01/03/2007 
Lamivudine/Zidovudine Tablet  II (Paddle)  75  0.1 N HCl  900  10, 20, 30 and 45  02/20/2004 
Lamivudine/Zidovudine + Efavirenz Tablet (copackage)  II (Paddle)  Lamivudine and Zidovudine: 75 Efavirenz: 50  Lamivudine and Zidovudine: 0.1 N HCl Efavirenz: 2% SLS in water  Lamivudine and Zidovudine: 1000 Efavirenz: 900  10, 20, 30, and 45   01/03/2007 
Lamivudine/Zidovudine + Nevirapine Tablet (copackage)  II (Paddle)  50  Lamivudine and Zidovudine: water Nevirapine: 0.06 M HCl (pH 1.2)  900  10, 15, 30, 45, 60  01/03/2007 
Lamivudine/Zidovudine/ Nevirapine Tablet  II (Paddle)  50  0.01 N HCl  900  10, 15, 30, 45, 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 
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 
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 
Letrozole Tablet      Refer to USP      04/10/2008 
Leucovorin Calcium Tablet      Refer to USP      07/14/2008 
Leuprolide Acetate Implant  15 mL conical polypropylene tubes in a 37 ± 0.5°C water bath  N/A  0.75% w/v Dulbecco's Phosphate Buffered Saline + 0.2% w/v NaN3  8 mL/tube  14, 28 and 42 days  07/14/2008 
Levetiracetam Tablet  II (Paddle)  50  Water (deaerated)  900  5, 10, 15 and 30  02/05/2004 
Levocetirizine Dihydrochloride Tablet  II (Paddle)  50  Water  900  10, 20, 30 and 45  08/11/2008 
Levofloxacin Tablet  I (Basket)  100  0.1 N HCl  900  10, 20, 30, and 45  06/18/2007 
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 
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 
Lopinavir/Ritonavir Tablet (Combination)  II (Paddle)  75  0.06 M Polyoxyethylene 10 Lauryl Ether  900  15, 30, 60, 90, and 120  09/13/2007 
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 
Lorazepam Tablet      Refer to USP      01/14/2008 
Losartan Potassium Tablet  II (Paddle)  50  Water (deaerated)  900  10, 20, 30 and 45  02/06/2004 
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 
Magnesium Hydroxide/Omeprazole/Sodium Bicarbonate Tablet (Chewable)  II (Paddle)  150  pH 7.4 Phosphate Buffer with 0.5% SDS  900  15, 30, 45, 60 and 90  10/06/2008 
Magnesium Hydroxide/Omeprazole/Sodium Bicarbonate Tablet (Chewable)  II (Paddle)  150  0.029 M sodium phosphate buffer w/ 0.5% SDS, pH 7.4  900  15, 30, 45, and 60  02/19/2008 
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 
Mefloquine HCl Tablet  I (Basket)  100  SGF without enzyme  900  10, 20, 30, 45 and 60  02/06/2004 
Meloxicam Suspension  II (Paddle)  25  Phosphate buffer at pH 7.5  900  5, 10, 15 and 30  01/26/2006 
Meloxicam Tablet  II (Paddle)  75  Phosphate Buffer, pH 7.5  900  10, 20, 30, 45 and 60  02/20/2004 
Melphalan Tablet      Refer to USP      07/14/2008 
Memantine HCL Tablet  I (Basket)  100  0.1 N HCl with NaCl (12 g NaCl in 6 L water adjust pH to 1.2 with HCl)  900  10, 20, 30 and 45  12/16/2005 
Meprobamate Tablet      Refer to USP      11/25/2008 
Mercaptopurine Tablet  II (Paddle)  50  0.1 N HCl  900  20, 30, 45, 60, 90 and 120  02/06/2004 
Mesalamine Tablet (Delayed Release)      Refer to USP      12/03/2007 
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 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 
Metaxalone Tablet  II (Paddle)  100  0.5% SLS in water  900  30, 60, 90 and 120  02/06/2004 
Metformin HCl Tablet (Extended Release)      Refer to USP      12/12/2008 
Metformin HCl Tablet      Refer to USP      04/10/2008 
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/Sitagliptin Phosphate Tablet  II (Paddle)  75  0.025 M NaCl  900  10, 15, 20, and 30  10/06/2008 
Methadone HCl Tablet      Refer to USP      07/14/2008 
Methimazole Tablet      Refer to USP      01/14/2008 
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 Tablet (Extended Release)  VII (Reciprocating holder) with oral extended release tablet holder (spring holder)  30 cycles per min  Water, pH 3.0 at 37oC  250  1, 2, 4, 6, 8 and 10 hours  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 (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      07/14/2008 
Metoclopramide Tablet      Refer to USP      07/25/2007 
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  I (Basket)  100  0.1 N HCl  900  10, 20, 30 and 45  02/09/2004 
Midodrine HCl Tablet  II (Paddle)  50  0.1 N HCl  900  5, 10, 15 and 30  02/06/2004 
Mifepristone Tablet  II (Paddle)  75  0.01 N HCl  900  5, 10, 15, 20 and 30  01/14/2008 
Miglustat Capsule  I (Basket)  100  0.1 N HCl  1000  10, 20, 30 and 45   01/03/2007 
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 Tablet      Refer to USP      07/25/2007 
Minoxidil Tablet      Refer to USP      04/15/2008 
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 
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 
Moxifloxacin Tablet  II (Paddle)  50  0.1 N HCl  900  15, 30, 45, 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 
Naltrexone HCl Tablet      Refer to USP      04/15/2008 
Naproxen Tablet      Refer to USP      07/25/2007 
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 
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 
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 
Nicardipine HCl Capsule  II (Paddle)  50  0.033 M Citric Acid Buffer, pH 4.5  900  10, 20, 30 and 45  02/11/2004 
Nicardipine HCl Capsule (Extended Release)  II (Paddle)  50  0.1 N HCl  1000  0.5 , 2 and 6 hours  07/14/2008 
Nifedipine Tablet (Extended Release)      Refer to USP      07/25/2007 
Nimodipine Capsule  II (Paddle)  50  0.5% SDS in water  900  10, 20, 30, and 45  04/09/2007 
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 
Nizatidine Capsule      Refer to USP      01/14/2008 
Norethindrone (AB1) Tablet  II (Paddle)  75  0.1 N HCl, 0.02% SLS  900  15, 30, 45, 60, and 75  01/03/2007 
Norethindrone (AB2) Tablet  II (Paddle)  75  0.09% SLS in 0.1 N HCl (same as Noreth./EE USP method)  500  15, 30, 45, and 60  01/03/2007 
Nystatin Tablet  II (Paddle)  75  Water with 0.1% SLS  900  15, 30, 45, 60 and 90  01/03/2007 
Ofloxacin Tablet  I (Basket)  100  0.1 N HCl  900  10, 20, 30 and 45  02/12/2004 
Olanzapine Tablet  II (Paddle)  50  0.1 N HCl  900  5, 10, 20 and 30  02/12/2004 
Olanzapine (Orally disintegrating) Tablet (Orally Disintegrating)  II (Paddle)  50  0.1 N HCl  900  5, 10, 15 and 30  02/12/2004 
Olmesartan Tablet  II (Paddle)  50  0.05 M Phosphate Buffer, pH 6.8  900  10, 20, 30 and 45  07/09/2007 
Olsalazine Sodium Capsule  I (Basket)  100  Phosphate Buffer, pH 7.5  900  10, 20, 30 and 45  02/12/2004 
Omeprazole Capsule (Delayed Release)      Refer to USP      06/18/2007 
Omeprazole Magnesium OTC Tablet (Delayed Release)  II (Paddle)  100  Tablets are pre-exposed to 300 ml of 0.1M HCL for 2 hrs and then 700 ml of 0.086 M Na2HPO4 is added to the medium containing the capsule to give 1000 ml with pH 6.8  300 ml for the acid stage; 1000 ml for the buffer stage  Sampling started at the buffer stage 10, 20, 30, 45 and 60  01/03/2007 
Omeprazole Sodium Bicarbonate Powder for suspension (Immediate Release)  II (Paddle)  50  0.25 mM Sodium Phosphate Buffer, pH 7.4  900  5, 10, 15, and 30  06/20/2007 
Omeprazole Sodium Bicarbonate Capsule  II (Paddle)  75  Phosphate Buffer, pH 7.4  900  15, 30, 45 and 60  07/14/2008 
Ondansetron Tablet (Orally Disintegrating)      Refer to USP      06/18/2007 
Ondansetron 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)  II (Paddle)  50  0-1 hr: 0.1N HCl. After 1 hr: pH 7.5 buffer  800 mL for HCl, and 900 mL for buffer  0.5, 1, 2, 4, 10, and 12 hours  07/25/2007 
Oseltamivir Phosphate Capsule  II (Paddle)  50  0.1 N HCl  900  5, 10, 20, and 30  01/03/2007 
Oxaprozin Tablet  II (Paddle)  75  0.05 M Phosphate Buffer, pH 7.4  1000  10, 20, 30, 45 and 60  02/12/2004 
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       
Oxycodone HCl Tablet      Refer to USP      01/14/2008 
Oxycodone Hydrochloride Tablet (Extended Release)  I (Basket)  100  SGF w/o Enzymes  900  1, 4, 8, 12, and 15 hours  04/09/2007 
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)  50  pH 4.5 phosphate buffer  900  1, 4, 6, 10, and 14 hours  12/03/2007 
Paliperidone Tablet (Extended Release)  Reciprocating Disk (Apparatus 7)  30 cycles per minute  NaCl 0.2% w/w in 0.0825 N HCl pH 1.0  50  2, 8, 14, 18, and 24 hours  12/03/2007 
Pantoprazole Sodium Tablet (Delayed release)  II (Paddle)  100  Acid stage: 0.1 N HCl for 2 hrs Buffer stage: phosphate buffer, pH 6.8  1000  1, 2 hrs (Acid stage) 10, 20, 30, 45 and 60 (buffer stage)  03/04/2006 
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)  II (Paddle)  150  Step 1: 0.1 N HCl for 2 hours; Step 2: Tris Buffer containing 50 mM Tris, pH 7.5  750 (step 1); 1000 (step 2)  2 hours (step 1), 1, 2, 4 and 6 hours (step 2)  11/25/2008 
Paroxetine HCl Tablet      Refer to USP      01/14/2008 
Paroxetine HCl Suspension  II (Paddle)  100  SGF without enzyme  900  10, 20, 30 and 45  02/13/2004 
Pemoline Tablet  II (Paddle)  75  Water (deaerated)  900  10, 20, 30, 45, 60 and 90  02/13/2004 
Penicillamine Capsule      Refer to USP      09/03/2008 
Pentosan Polysulfate Sodium Capsule  I (Basket)  50  Water  900  5, 15, 30, 45 and 60  04/15/2008 
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 
Phenoxybenzamine HCl Capsule      Refer to USP      04/10/2008 
Phentermine HCl Capsule      Refer to USP      01/14/2008 
Phenytoin Tablet (Chewable)      Refer to USP      01/14/2008 
Phenytoin Suspension      Refer to USP      06/18/2007 
Phenytoin Sodium Capsule      Refer to USP      06/18/2007 
Pilocarpine HCl Tablet  II (Paddle)  50  0.1 N HCl  500  10, 20, 30, 45 and 60  01/20/2004 
Pimozide Tablet      Refer to USP      02/19/2008 
Pioglitazone HCl Tablet  II (Paddle)  75  HCl-0.3 M KCl Buffer, pH 2.0  900  5, 10, 15 and 30  02/13/2004 
Posaconazole Oral Suspension  II (Paddle)  25  0.3% SLS  900  10, 20, 30, and 45  12/03/2007 
Potassium Chloride Tablet (Extended Release)      Refer to USP      07/25/2007 
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 
Pravastatin Sodium Tablet  II (Paddle)  50  Water (deaerated)  900  5, 10, 20 and 30  02/13/2004 
Prednisolone Tablet      Refer to USP      11/25/2008 
Prednisolone Sodium Phosphate Tablet (Orally Disintegrating)  II (Paddle)  50  22 mM Sodium Acetate Buffer, pH 4.5  500  5, 15, 30, 45, 60  09/03/2008 
Pregabalin Capsule  II (paddle)  50  0.06 N HCl  900  10, 20, 30 and 45  03/22/2006 
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  1 (Suppository, dissolution baskets, palmieri type)  100  0.1 N HCl at 38 deg. C  900  10, 20, 30 and 45   08/17/2006 
Promethazine HCl Tablet      Refer to USP      07/25/2007 
Propafenone HCl Capsule (Extended Release)  II (Paddle)  50  0-2 hours: 0.08 N HCl 2-15 hours: phosphate buffer, pH 6.8  900  1, 2, 4, 8, 10,12 and 15 hours  03/11/2008 
Propafenone HCl Tablet  II (Paddle)  75  0.1 N HCl  900  10, 20, 30 and 45  02/13/2004 
Propranolol HCl Capsule (Extended Release)      Refer to USP      07/25/2007 
Protriptyline HCl Tablet      Refer to USP      01/14/2008 
Pseudoephedrine HCl Tablet (Extended Release)      Refer to USP      01/14/2008 
Quetiapine Fumarate Tablet  II (Paddle)  50  Water (deaerated)  900  10, 20, 30 and 45  02/18/2004 
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-HCl buffer, pH 8.0 (buffer stage). Stabilize the samples with the addition of 0.5 N NaOH  Acid: 700 Buffer: 1000  10, 20, 30, and 45   04/09/2007 
Raloxifene HCl Tablet  II (Paddle)  50  0.1% Polysorbate 80 in water  1000  10, 20, 30 and 45  02/18/2004 
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 
Ranolazine Tablet (Extended Release)  II (Paddle)  50  0.1 N HCl  900  0.5, 2, 4, 8, 12, 20, and 24 hours  06/03/2008 
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 
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 
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 
Risedronate Sodium (5 mg, 30 mg and 35 mg) Tablet  II (Paddle)  50  Water (deaerated)  500  10, 20, 30 and 45  11/25/2008 
Risedronate Sodium (75 mg and 150 mg) Tablet  II (Paddle)  50  Water (deaerated)  900  10, 20, 30, 45 and 60  11/25/2008 
Risedronate Sodium/Calcium Carbonate Tablet (Copackaged)  For Risedronate Tablets:Paddle  For Risedronate Tablets:50  For Risedronate Tablets:Water; For Calcium Carbonate Tablets: using USP method.  For Risedronate Tablets:500 ml  10, 20, 30 and 45  01/03/2007 
Risperidone Tablet  II (Paddle)  50  0.1N 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 Capsule  II (Paddle)  50  0.1 N HCl with 25 mM Polyoxyethylene 10 Laurylether (POE10LE)  900  10, 20, 30 and 45  02/18/2004 
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 
Ropinirole HCl Tablet  I (Basket)  50  Citrate Buffer, pH 4.0  500  5, 10, 15 and 30  01/03/2007 
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 Citrate buffer pH 6.6  900  10, 20, 30 and 45  12/20/2005 
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 
Selegiline HCl Tablet (Orally Disintegrating)  I (Basket)  50  Water  500  5, 10, 15, and 20  10/06/2008 
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 
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 
Sirolimus Tablet  Basket (20 mesh)  120  0.4% SLS in water  500  10, 20, 30, 45, 60 and 120  03/14/2007 
Sodium Iodide I-123 Capsule  I (Basket)  100  Water (deaerated)  500  5, 10, 15 and 30  07/14/2008 
Solifenacin Succinate Tablet  II (Paddle)  50  Water  900  10, 15, 30, and 45  02/19/2008 
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 
Sulfadiazine Tablet      Refer to USP      07/14/2008 
Sulfamethoxazole/Trimethoprim Tablet      Refer to USP      01/14/2008 
Sulfamethoxazole/Trimethoprim Suspension  II (Paddle)  50  1 mL of 0.2 N HCl in water  900  10, 20, 30, 45, 60 and 90  02/25/2004 
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 M HCl  900  5, 10, 15 and 30  03/04/2006 
Tacrolimus Capsule  II (Paddle)  50  Hydroxypropyl Cellulose Solution (1 in 20,000). Adjust to pH 4.5 by Phosphoric Acid  900  30, 60, 90 and 120  02/20/2004 
Tadalafil Tablet  II (Paddle)  50  0.5% Sodium Lauryl Sulfate  1000  10, 20, 30 and 45  01/26/2006 
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 
Telithromycin Tablet  II (Paddle)  50  0.1 N HCl  900  10, 20, 30 and 45  01/03/2007 
Telmisartan Tablet  II (Paddle)  75  Phosphate Buffer, pH 7.5  900  10, 20, 30 and 45  03/04/2006 
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 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 
Testosterone Buccal Tablet (Extended Release)  II (Paddle, may use sinker)  60  1% sodium dodecyl sulfate in double distilled water  1000  1, 2, 4, 6, 10, 12 and 24 hours  01/03/2007 
Testosterone Pellet Implant      Develop a dissolution method       11/25/2008 
Testosterone (AB) Gel      Develop a dissolution method       11/25/2008 
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 
Tiagabine HCl Tablet  II (Paddle)  50  Water  900  5, 10, 15, 20, and 30  01/03/2007 
Ticlopidine HCl Tablet  II (Paddle)  50  Water (deaerated)  900  10, 20, 30, 45 and 60  02/19/2004 
Tinidazole Tablet  I (Basket)  100  Water (Deaerated)  900  10, 20, 30 and 45  01/03/2007 
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 
Tolcapone Tablet  II (Paddle)  75  Borate Buffer, pH 6.8 with 1% SLS  900  10, 20, 30 and 45  02/20/2004 
Tolterodine Tartrate Tablet  II (Paddle)  50  SGF without enzymes, pH 1.2  900  5, 10, 15 and 30  02/20/2004 
Tolterodine Tartrate Capsule (Extended Release)  I (Basket)  100  Phosphate buffer (pH 6.8)  900  1, 3, 7 hours  06/18/2007 
Topiramate Capsule (Sprinkle)  II (Paddle)  50  Water (deaerated)  900  10, 20, 30, 45 and 60  02/19/2004 
Topiramate Tablet  II (Paddle)  50  Water (deaerated)  900  5, 10, 20 and 30  02/19/2004 
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 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, 16 hours  01/03/2007 
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 
Triamterene Capsule      Refer to USP      06/18/2007 
Trimipramine Maleate Capsule  I (Basket)  100  Water (deaerated)  1000  10, 20, 30, 45, 60 and 90  03/04/2006 
Triptorelin Pamoate Injectable Suspension  II (Paddle)  200  Water-Methanol (95:5); Reconstitute vial in 2 mL Water for Injection, add to 500 mL medium at 37°C  500  1, 6, 12, 24, 48 and 72 hours  07/14/2008 
Trospium Chloride Capsule (Extended Release)  II (Paddle) with sinker  50  0.1 N HCl, pH 1.1 for 2 hrs then adjust pH to 7.5 with addition of 200 mL of 0.1 N NaOH in 200 mM Phosphate Buffer  0-2 hrs: 750 ml, After 2 hrs: 950 ml.  2, 3, 4, 8, 12 and 16 hours  09/03/2008 
Trospium Chloride Tablet  II (Paddle)  50  0.1 N HCl  1000  10, 20, 30 and 45  12/03/2007 
Ursodiol Tablet      Refer to USP      04/15/2008 
Valganciclovir HCl Tablet  II (Paddle)  50  0.1 N HCl  900  10,15, 30, 45, 60  06/18/2007 
Valsartan (Tab & Cap) Tablet  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 
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  0.01N HCl  500  5, 10, 15 and 30  12/03/2007 
Venlafaxine HCl Tablet  II (Paddle)  50  Water (deaerated)  900  5, 10, 15 and 30  02/19/2004 
Venlafaxine HCl Capsule (Extended Release)  I (Basket)  100  Water  900  2, 4, 8, 12, and 20 hours  01/03/2007 
Verapamil HCl Tablet      Refer to USP      11/04/2008 
Verapamil HCl (100, 200, 300 mg) Capsule (Extended Release)  I (Basket)  75  Water, pH 3.0 (adjusted with 0.1 N or 2 N HCl)  1000  1, 4, 8, 11, and 24 hours  01/03/2007 
Verapamil HCl (120, 180, 240, 360 mg) Capsule (Sustained Release)  I (Basket)  75  Water, pH 3.0 (adjusted with 0.1 N or 2 N HCl)  1000  1, 4, 8, 11, and 24 hours  01/03/2007 
Voriconazole Suspension  II (Paddle)  50  0.1 N HCl  900  10, 20, 30 and 45  01/03/2007 
Voriconazole Tablet  II (Paddle)  50  0.1 N HCl  900  10, 20, 30 and 45  11/25/2008 
Vorinostat Capsule  II (Paddle) with sinker  100  2% Tween 80 in Water  900  5, 15, 30, 45 and 60  09/03/2008 
Zafirlukast Tablet  II (Paddle)  50  1% w/v Aqueous Sodium Dodecyl Sulfate  1000  10. 30, 30 and 45  10/09/2007 
Zalcitabine Tablet      Refer to USP  900    02/19/2008 
Zaleplon Capsule  II (Paddle)  75  Deionized Water  900  5, 10, 20, and 30  01/03/2007 
Zidovudine Tablet      Refer to USP      07/25/2007 
Zidovudine Capsule      Refer to USP      06/18/2007 
Zileuton Tablet  II (Paddle)  50  0.05 M SLS in water  900  10, 20, 30, 45 and 60  02/19/2004 
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, and 30  06/18/2007 
Zolpidem Tartrate Tablet (Extended Release)  I (Basket)  100  0.01 N HCl  500  15, 30, 90, 120 and 240  04/09/2007 
Zolpidem Tartrate Tablet  II (Paddle)  50  0.01 N HCl, pH 2.0  900  5, 10, 15 and 30  02/19/2004 
Zonisamide Capsule  II (Paddle)  50  Water (deaerated)  900  10, 20, 30, and 45   01/03/2007 


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FDA/Center for Drug Evaluation and Research
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Division of Bioequivalence
Update Frequency: Quarterly
Data Current through: September 24, 2008
Last Updated: September 24, 2008