methods that are not binding on FDA or others.
Purpose of the Dissolution Methods Database:
For a drug product that does not have a dissolution test method
in the United States Pharmacopeia (USP), the FDA Dissolution
Methods Database provides information on dissolution methods presently recommended by the Division of Bioequivalence, Office of
Generic Drugs. US FDA providing the Dissolution Methods Database to aid industry personnel in developing generic drug products.
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
Abiraterone Acetate Tablet II (Paddle) 50 0.25% SLS in 56.5 mM
phosphate buffer, pH 4.5
900 10, 20, 30, 45 and 60
02/28/2013
Acamprosate Calcium Tablet (Delayed Release)
I (Basket) 180 Acid Stage: 0.1 N HCl Buffer Stage: "Citrate-sodium hydroxide" buffer pH 6.8 (150 ml of 2N NaOH, 21.014 gm of citric acid and ultra-pure water to 1000 ml) (Method B)
1000 120 (Acid) 30, 60, 90, 120, and 180 (buffer)
12/20/2005
Acarbose Tablet II (Paddle) 75 Water (deaerated) 900 10, 15, 20, 30 and
45
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/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/Propoxyphene HCl Tablet Refer to USP 01/15/2010
Acetaminophen/Propoxyphene Napsylate Tablet Refer to USP 01/15/2010
Acetaminophen/Tramadol HCl Tablet II (Paddle) 50 0.1 N HCl 900 5, 10, 15, 20 and
30
03/04/2006
Acetazolamide Tablet Refer to USP 07/21/2011
Acetazolamide Capsule (Extended
Release)
II (Paddle) 75 Acetate Buffer, pH 4.5 with 2.2% Tween 20
900 1, 2, 5, 7, 9, 12 and 14 hours
01/15/2010
Acetazolomide Tablet Refer to USP 07/14/2008
Acitretin Capsule Refer to USP 09/22/2011
Acrivastine/Pseudoephedrine HCl Capsule II (Paddle) 50 0.01 N HCl 900 5, 10, 15 and 30 01/12/2004
Acyclovir Suspension II (Paddle) 50 0.1 N HCl 900 10, 20, 30, 45 and
60
02/20/2004
Acyclovir Tablet 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
Albendazole Tablet Refer to USP 08/15/2013
Albuterol Sulfate Tablet (Extended Release)
II (Paddle) 50 0.1 N HCl 900 1, 2, 4, 6, 9 and 12 hours
04/09/2007
Albuterol Sulfate Tablet Refer to USP 09/03/2008
Alendronate Sodium Tablet Refer to USP 01/14/2008
Alendronate Sodium/Cholecalciferol Tablet II (Paddle) For Alendronate: 50; For
Cholecalciferol: 75
For Alendronate: Deaerated Water; For Cholecalciferol: 0.3% SDS in USP Water
For Alendronate: 900; For
Cholecalciferol: 500
10, 15, 20, 30 and 45
11/25/2008
Alfuzosin HCl Tablet (Extended
Release)
II (Paddle) 100 0.01 N HCl 900 1, 2, 12, 20 hours 06/18/2007
Aliskiren Hemifumarate Tablet I (Basket) 100 0.01 N HCl 500 10, 20, 30 and 45 09/03/2008
Aliskiren Hemifumarate/Amlodipine Besylate
Tablet I (Basket) 100 0.01 N HCl, pH 2.0 500 10, 15, 20, 30 and 45
06/07/2012
Aliskiren Hemifumarate/Amlodipine Besylate/Hydrochlorothiazide
Tablet I (Basket) 100 0.01 N HCl 900 10, 15, 20, 30 and
45
06/07/2012
Aliskiren
Hemifumarate/Hydrochlorothiazide
Tablet I (Basket) 100 0.1 N HCl 900 10, 15, 20, 30 and
45
10/08/2009
Aliskiren Hemifumarate/Valsartan Tablet I (Basket) 100 Phosphate Buffer, pH 6.8
1000 5, 10, 15, 20, 30 and 45
12/23/2010
Allopurinol Tablet Refer to USP 07/25/2007
Almotriptan Malate Tablet II (Paddle) 50 0.1 N HCl 900 5, 10, 15, and 30 01/20/2006
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
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 Tablet II (Paddle) 50 Water (deaerated) 500 10, 20, 30, 45 and
60
01/12/2004
Amantadine HCl Capsule Refer to USP 12/23/2010
Ambrisentan Tablet II (Paddle) 75 0.05 M Acetate Buffer,
pH 5.0
900 5, 10, 15, 30, and 45
05/20/2009
Amiloride HCl Tablet Refer to USP 06/07/2012
Amiloride HCl/Hydrochlorothiazide Tablet Refer to USP 06/07/2012
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/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
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 II (Paddle) 50 Phosphate Buffer, pH 6.8
900 10, 20, 30 and 45 03/25/2010
Amlodipine
Besylate/Hydrochlorothiazide/Valsartan (10/25/320 mg)
Tablet II (Paddle) 55 Phosphate Buffer, pH 6.8
900 10, 20, 30 and 45 03/25/2010
Amlodipine Besylate/Olmesartan Medoxomil
Tablet II (Paddle) 50 Phosphate Buffer, pH 6.8
900 10, 20, 30 and 45 08/11/2008
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 II (Paddle) 75 Phosphate Buffer, pH 6.8
1000 5, 10, 15, 20, 30 and 45
07/21/2011
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
Amoxicillin/Clarithromycin/Lansoprazole Capsule/Tablet/Capsule (Copackage)
Refer to USP for
monographs of Amoxicillin Capsules, Clarithromycin Tablets and Lansoprazole Delayed-Release Capsules
02/28/2013
Amoxicillin/Clarithromycin/Omeprazole Capsule/Tablet/Capsule (Copackage)
Refer to USP for
monographs of Amoxicillin Capsules, Clarithromycin Tablets and Omeprazole Delayed-Release Capsules
02/28/2013
Amoxicillin/Clavulanate Potassium Tablet Refer to USP As appropriate 0, 0.5, 1, 2, 3, 4 and 5 hours
10/04/2012
Amoxicillin/Clavulanate Potassium Suspension II (Paddle) 75 Water (deaerated) 900 5, 10, 15 and 30 01/14/2004
Amoxicillin/Clavulanate Potassium Tablet (Chewable) Refer to USP 01/14/2008
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
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
Apixaban Tablets 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
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
Asenapine Maleate Tablet (Sublingual) II (Paddle) 50 Acetate Buffer, pH 4.5 500 1, 2, 3, 4 and 5 05/09/2013
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
Aspirin/Dipyridamole Capsule I (Basket) 100 0.01 N HCl for first hour, 0.1 M Phosphate Buffer, pH 5.5, thereafter
0-1 hrs: 900 mL. 900 mL thereafter
Acid: 10, 20, 30, 45 and 60 min; Buffer:1, 2, 5, and 7 hrs
10/09/2007
Aspirin/Hydrocodone Bitartrate Tablet II (Paddle) 75 Acetate Buffer, pH 4.5 900 10, 20, 30, 45, 60 and 90
01/15/2004
Aspirin/Meprobamate Tablet I (Basket) 100 Water (deaerated) 900 10, 20, 30, 45, 60 and 90
01/15/2004
Aspirin/Methocarbamol Tablet II (Paddle) 50 Water (deaerated) 900 10, 20, 30, 45, 60 and 90
01/15/2004
Aspirin/Oxycodone HCl Tablet Refer to USP 01/15/2010
Atazanavir Sulfate Capsule II (Paddle) 50 0.025 N HCl 1000 10, 20, 30 and 45 01/20/2006
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 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
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
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 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
Azithromycin Tablet II (Paddle) 75 0.1 M Phosphate Buffer,
pH 6.0
900 10, 20, 30 and 45 01/14/2008
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 Capsule II (Paddle) with sinker
50 pH 6.8 buffer 900 10, 20, 30, and 45 01/26/2006
Balsalazide Disodium Tablet II (Paddle) 100 Water (degassed) 1000 10, 20, 30, 45, 60, 75, 90 and 120
07/31/2013
Bedaquiline Fumarate Tablet I (Basket) 150 0.01N 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
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
Betamethasone Acetate/Betamethasone Sodium Phosphate
Injectable Suspension IV (Flow through cell)
Flow @ 8 mL/min
0.05% SLS, pH 3.0 or Develop an in vitro release method using USP IV (Flow-Through Cell), and, if applicable, Apparatus II (Paddle) or any other appropriate method, for comparative evaluation by the Agency
5, 10, 15, 30, 45, 60, 90, 120, 180, 240, 300, and 360
04/08/2010
Bethanechol Chloride Tablet Refer to USP 10/06/2008
Bexarotene Capsule II (Paddle) 50 Tier 1 Medium: 0.5%
HDTMA in 0.05 M phosphate buffer, pH 7.5 Tier 2 Medium: 0.5% HDTMA in 0.05 M phosphate buffer, pH 7.5 with 0.05 g/L pancreatin enzyme
900 15, 30, 45 and 60 08/17/2006
Bicalutamide Tablet II (Paddle) 50 1% SLS in water 1000 10, 20, 30, 45 and
60
12/15/2005
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
Brinzolamide Ophthalmic
Suspension
Develop a method to
characterize in vitro release
09/01/2011
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: 1, 2, 4, 6 and 8 hours
05/20/2009
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/Naloxone HCl Tablet (Sublingual) I (Basket) 100 Water 500 1, 3, 5, 7.5, 10, 15 and 20
07/01/2010
Buprenorphine HCl/Naloxone HCl Film (Sublingual) V (Paddle over Disk) with 56mm, 40 mesh stainless steel disk.
100 Acetate Buffer, pH 4.0 900 1, 2, 3, 5, 7 and 10
05/09/2013
Bupropion HCl Tablet Refer to USP 08/15/2013
Bupropion HCl Tablet (Extended
Release)
Refer to USP 07/25/2007
Bupropion Hydrobromide Tablet (Extended Release)
I (Basket) 75 0.1N HCl 900 1, 2, 4, 6, 8 and 10 hours
06/10/2009
Buspirone Hydrochloride Tablet Refer to USP 07/21/2009
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 Capsule II (Paddle) 50 Water 900 5, 10, 15, 20 and
30
07/21/2009
Calcium Acetate Tablet Refer to USP 01/14/2008
Candesartan Cilexetil (16 mg, 8 mg and 4 mg)
Tablet II (Paddle) 50 0.35% Polysorbate 20 in 0.05 M Phosphate Buffer, pH 6.5
900 10, 20, 30, 45 and 60
06/20/2007
Candesartan Cilexetil (32 mg) Tablet II (Paddle) 50 0.70% Polysorbate 20 in 0.05 M Phosphate Buffer, pH 6.5
900 10, 20, 30, 45 and 60
06/20/2007
Candesartan Cilexetil/Hydrochlorothiazide (16/12.5 mg)
Tablet II (Paddle) 50 0.35% Polysorbate 20 in phosphate buffer pH 6.5
900 10, 20, 30, 45 and 60
01/29/2010
Candesartan Cilexetil/Hydrochlorothiazide (32/12.5 mg and 32/25 mg)
Tablet II (Paddle) 50 0.70% Polysorbate 20 in phosphate buffer pH 6.5
900 15, 20, 30, 45 and 60
01/29/2010
Capecitabine Tablet II (Paddle) 50 Water (deaerated) 900 10, 20, 30 and 45 01/23/2004
Carbamazepine Suspension II (Paddle) 50 Water (deaerated) 900 10, 20, 30, 45 and
60
01/20/2004
Carbamazepine Tablet (Extended
Release)
Refer to USP 01/14/2008
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
Carbamazepine Tablet (Chewable) II (Paddle 75 1% SLS in Water 900 15, 30, 45, 60 and 90
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 (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
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
Carglumic Acid Tablet II (Paddle) 100 0.05M Phosphate Buffer,
pH 6.8
750 5, 10, 15, 20 and 30
08/15/2013
Carisoprodol Tablet Refer to USP 01/29/2010
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, 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
Cefixime Suspension II (Paddle) 50 0.05 M Phosphate
buffer, pH 7.2
900 10, 20, 30 and 45 04/09/2007
Cefixime Tablet Refer to USP 12/23/2010
Cefixime Tablet (Chewable) II (Paddle 25 Phosphate Buffer, pH
7.2
900 10, 15, 20, 30, and 45
12/23/2010
Cefixime Capsule I (Basket) 100 0.05 M Phosphate
Buffer, pH 7.2
900 10, 20, 30, 45 and 60
08/15/2013
Cefpodoxime Proxetil 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 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 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
Celecoxib Capsule II (Paddle) 50 mg, 100 mg
and 200 mg: 50 rpm; 400 mg: 75 rpm
Tier 1 Medium: 0.04 M tribasic sodium
phosphate (pH 12) with 1% SLS. Tier 2 Initial Medium: 750 mL of simulated gastric fluid, USP (includes pepsin); At 20 minutes, while stirring, add 180 mL of appropriate
concentrations of SLS solution (for a final concentration of 1% SLS). Add about 70 mL of 1.2 N NaOH to adjust the pH to 12.
Tier 1: 1000 mL Tier 2: 750 mL (initial) 1000 mL (final)
10, 20, 30, 45 and 60
07/01/2010
Cephalexin Suspension II (Paddle) 25 Water 900 5, 10, 20, and 30 07/25/2007
Cephalexin Capsule Refer to USP 04/02/2009
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
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 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
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 HCl Tablet Refer to USP 09/02/2010
Ciprofloxacin HCl Tablet (Extended Release)
I (Basket) 100 0.1 N HCl 900 1, 2, 4, and 7 hours or until at least 80% released
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
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 900 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
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
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
Clopidogrel Bisulfate Tablet Refer to USP 07/25/2007
Clorazepate Dipotassium Tablet Refer to USP 01/31/2013
Clotrimazole Lozenge Refer to USP 10/06/2008
Clotrimazole Tablet (Vaginal) II (Paddle) 50 0.1 N HCl 900 10, 20, 30 and 45 01/24/2004
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
Codeine Sulfate Tablet Refer to USP 09/01/2011
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
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
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
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
Dapsone Tablet Refer to USP 12/23/2010
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
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
Dasatinib Tablet II (Paddle) 60 pH 4.0 Acetate buffer
containing 1% Triton X-100
1000 10, 15, 30 and 45 10/30/2009
Deferasirox Tablet (for Oral
Suspension)
II (Paddle) 50 Phosphate buffer pH 6.8 with 0.5% Tween 20
900 10, 20, 30 and 45 06/21/2006
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 (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
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
Desvenlafaxine Succinate Tablet (Extended Release)
I (Basket) 100 0.9% NaCl in water 900 1, 2, 4, 8, 12, 16, 20 and 24 hours
04/02/2009
Dexamethasone 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 24 hours
10/21/2010
Dexamethasone Tablet Refer to USP 04/02/2009
Dexamethasone/Tobramycin Ophthalmic Suspension
Develop a method to
characterize in vitro release
04/02/2009
Dexlansoprazole Capsule (Delayed
Release)
I (Basket) 100 Acid Stage: 0.1 N HCl, Buffer Stage: pH 7.0 Phosphate Buffer with 5 mM SLS
Acid stage: 500; Buffer stage: 900
Acid stage: 120; Buffer Stage: 10, 20, 40, 50, 60 , 75, 105 and 120
08/05/2010
Dexmethylphenidate HCl Tablet I (Basket) 100 Water 900 10, 15, 30, and 45 06/18/2007
Dexmethylphenidate HCl Capsule (Extended Release)
I (Basket) 100 First 2 hours: 0.01 N HCl, Hours 2-10: Phosphate Buffer, pH 6.8
Acid: 500, Buffer: 500
0.5, 1, 2, 4, 6, and 10 hours
01/14/2008
Dextroamphetamine Sulfate 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
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
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
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
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
Divalproex sodium Tablet (Extended Release)
II (Paddle) 100 Acid phase: 0.1 N HCl for 45 minutes; Drug Release: (after 45 minutes) 0.05 M
Phosphate Buffer with 75 mM SDS, pH 5.5
Acid phase:500 mL; Drug release: 900 mL
1.5, 3, 6, 9, 12, 15, 18, 21 and 24 hours
10/28/2010
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
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
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 (Extended Release)
II (Paddle) 75 SGF without enzyme 900 1, 2, 4, 6, 8, 12 and 16 hours
01/03/2007
Doxazosin Mesylate Tablet II (Paddle) 50 0.01 N HCl 900 10, 20, 30, 45 and
60
01/27/2004
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
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 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
Doxycycline Hyclate Tablet (Delayed Release)
I (Basket) 50 Acid stage: 0.06 N HCl; Buffer stage: Neutralized Phthalate Buffer, pH 5.5
Acid stage: 900; Buffer stage: 1000
Acid stage: 5, 10, 15, 20 and 30; Buffer stage: 10, 20, 30 and 45
04/02/2009
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) 75 pH 4.5 Phosphate buffer 1000 10, 15, 20, 30, 45, 60, 90 and 120
08/05/2010
Drospirenone/Estradiol Tablet II (Paddle) 50 Water 900 10, 20, 30, and 45 01/03/2007
Drospirenone/Ethinyl Estradiol Tablet II (Paddle) 50 Water 900 10, 20, 30, and 45
Drospirenone/Ethinyl
Estradiol/Levomefolate Calcium
Tablet II (Paddle) 50 Phosphate Buffered Saline pH 6.8 containing 0.03% ascorbic acid
900 5, 10, 15, 20, 30 and 45
01/05/2012
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 (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. TamsulosinAcid 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
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
Eletriptan Hydrobromide Tablet I (Basket) 100 0.1 N HCl 900 5, 10, 15 and 30 04/02/2009
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
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
Ergocalciferol Capsule II (Paddle) 100 0.5 N NaOH with 10%
Triton-X-100
500 15, 30, 45, 60 and 90
08/05/2010
Erlotinib HCl Tablet II (Paddle) 75 0.1 N HCl containing 1%
SDS
1000 15, 30, 45 and 60 03/22/2006
Erythromycin 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/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
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: 120; Buffer stage: 10, 20, 30, 45 and 60
02/26/2004
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
Estazolam Tablet II (Paddle) 50 Water (deaerated) 900 10, 20, 30 and 45 01/27/2004
Esterified Estrogens Tablet II (Paddle) 50 Water 900 15, 30, 45, 60, 90,
120 and 180
02/19/2008
Estradiol Vaginal Tablet I (Basket) 40 Phosphate Buffer, pH
4.75 ± 0.05
500 1, 2, 3, 5, 8, 10 and 12 hours
07/21/2009
Estradiol Vaginal Ring Incubator
shaker
130 0.9% Saline 250 1, 9, 16, 17, 18,
19, 45 days
01/03/2007
Estradiol (0.014 mg/24 hr) Film, Transdermal (Extended Release)
Develop a method to
characterize in vitro release
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/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 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 (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/Norethindrone Tablet Refer to USP 07/15/2009
Ethinyl Estradiol/Norethindrone Acetate Tablet Refer to USP 07/15/2009
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 0.1N 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 (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
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
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 0.01M 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 (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 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 Refer to USP 06/18/2007
Famotidine/Calcium Carbonate/Magnesium Hydroxide
Tablet (Chewable) Develop a dissolution method
12/15/2009
Famotidine/Ibuprofen Tablet II (Paddle) 50 0.05 M Phosphate
Buffer, pH 7.2
900 5, 10, 15, 20, 30 and 45
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
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 0.1M 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
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
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 Tablet (Orally Disintegrating)
II (Paddle) 50 0.001 N HCl 500 5, 10, 15, 30 and 45
09/03/2008
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 Suspension II (Paddle) 50 0.001 M HCl 900 10, 20, 30 and 45 11/25/2008
Fexofenadine HCl/Pseudoephedrine HCl Tablet (Extended Release)
Refer to USP 04/02/2009
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
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
Fluconazole (200 mg/5 mL) Suspension II (Paddle) 50 Water (deaerated) 900 10, 20, 30 and 45 01/30/2004
Fluconazole (50 mg/5 mL) Suspension II (Paddle) 50 Water (deaerated) 500 10, 20, 30 and 45 01/30/2004
Flucytosine Capsule Refer to USP 06/24/2010
Fludarabine Phosphate Tablet II (Paddle) 50 Water 900 5, 10, 15, 20 and
30
06/07/2012
Fludrocortisone Acetate Tablet Refer to USP 05/20/2009
Fluoxetine Capsules (Delayed
Release)
Refer to USP 07/25/2007
Fluoxetine HCl Capsule Refer to USP 09/02/2010
Fluoxetine HCl Tablet 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
Flutamide Capsule Refer to USP 01/31/2013
Fluvastatin Sodium Tablet (Extended Release)
I (Basket) 50 Water (deaerated) 1000 0.5, 2, 4, 6 and 8 hours
09/22/2011
Fluvastatin Sodium Capsule Refer to USP 01/14/2008
Fluvoxamine Maleate Tablet II (Paddle) 50 Water (deaerated) 900 10, 20, 30 and 45 01/03/2007
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
Fosamprenavir Calcium Oral Suspension II (Paddle) 25 10 mM HCl 900 5, 10,15 and 20 12/03/2007
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
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 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
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 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
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 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 II (Paddle) 75 Phosphate Buffer, pH 7.5
900 10, 15, 20, 30, 45 and 60
04/10/2008
Hydrochlorothiazide/Triamterene Tablet Refer to USP 07/31/2013
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
