Dissolution Methods FDA

29/11/13 Dissolution Methods

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List of all Drugs in the Database

Drug Name Dosage FormUSP

ApparatusSpeed (RPMs) Medium Volume (mL)

RecommendedSampling Times

(minutes)

DateUpdated

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 mMphosphate buffer, pH4.5

900 10, 20, 30, 45 and60

02/28/2013

Acamprosate Calcium Tablet (DelayedRelease)

I (Basket) 180 Acid Stage: 0.1 N HClBuffer Stage: "Citrate-sodium hydroxide" bufferpH 6.8 (150 ml of 2NNaOH, 21.014 gm ofcitric acid and ultra-purewater 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 and45

03/22/2006

Acetaminophen Suppository II (Paddle) 50 Phosphate buffer, pH 5 900 15, 30, 45, 60 and90

08/17/2006

Acetaminophen Tablet (ExtendedRelease)

Refer to USP 03/03/2011

Acetaminophen/Butalbital Tablet II (Paddle) 50 Water (deaerated) 900 15, 30, 45, 60 and90

01/03/2007

Acetaminophen/Butalbital/Caffeine Tablet Refer to USP 01/14/2008 Acetaminophen/Butalbital/Caffeine/CodeinePhosphate

Capsule II (Paddle) 50 Water (deaerated) 900 10, 20, 30, 45 and60

03/04/2006

Acetaminophen/Caffeine/DihydrocodeineBitartrate

Capsule I (Basket) 100 Water 900 10, 20, 30, 45 and60

01/03/2007

Acetaminophen/Caffeine/DihydrocodeineBitartrate

Tablet II (Paddle) 50 Water 900 10, 15, 30, 45 and60

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 Capsule Refer to USP 01/05/2012 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; ForCholecalciferol: 0.3%SDS in USP Water

For Alendronate:900; ForCholecalciferol: 500

10, 15, 20, 30 and45

11/25/2008

Alfuzosin HCl Tablet (ExtendedRelease)

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/AmlodipineBesylate

Tablet I (Basket) 100 0.01 N HCl, pH 2.0 500 10, 15, 20, 30 and45

06/07/2012

Aliskiren Hemifumarate/AmlodipineBesylate/Hydrochlorothiazide

Tablet I (Basket) 100 0.01 N HCl 900 10, 15, 20, 30 and45

06/07/2012

AliskirenHemifumarate/Hydrochlorothiazide

Tablet I (Basket) 100 0.1 N HCl 900 10, 15, 20, 30 and45

10/08/2009

Aliskiren Hemifumarate/Valsartan Tablet I (Basket) 100 Phosphate Buffer, pH6.8

1000 5, 10, 15, 20, 30and 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 (ExtendedRelease)

I (Basket) 100 1% Phosphate Buffer,pH 6.0

500 1, 4, 8, 12 and 16hours

02/08/2007

Alprazolam Tablet (OrallyDisintegrating)

II (Paddle) 50 70 mM PotassiumPhosphate Buffer, pH6.0

500 2, 5, 10, 15 and 20 10/06/2008

Alprazolam Tablet Refer to USP 06/18/2007

Dissolution Methods

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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 and60

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 7.5Phosphate Buffer

1000 Acid Stage: 2hours; 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, 60and 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, 60and 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 (OrallyDisintegrating)

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, pH6.8

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, and60

06/20/2007

AmlodipineBesylate/Hydrochlorothiazide/OlmesartanMedoxomil

Tablet II (Paddle) 50 Phosphate Buffer, pH6.8

900 5, 10, 15, 20, 30and 45

07/21/2011

AmlodipineBesylate/Hydrochlorothiazide/Valsartan


900 10, 20, 30 and 45 03/25/2010

AmlodipineBesylate/Hydrochlorothiazide/Valsartan(10/25/320 mg)


900 10, 20, 30 and 45 03/25/2010

Amlodipine Besylate/OlmesartanMedoxomil


900 10, 20, 30 and 45 08/11/2008

Amlodipine Besylate/Telmisartan Tablet II (Paddle) 75 Telmisartan: PhosphateBuffer, 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, pH6.8

1000 5, 10, 15, 20, 30and 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 potassiumphosphate monobasicbuffer at pH 4.0 (0-2hours), 6.0 (2-4 hours)and 6.8 ( 4 hours andbeyond)

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, 30and 45

06/06/2013

Amoxicillin/Clarithromycin/Lansoprazole Capsule/Tablet/Capsule(Copackage)

Refer to USP formonographs ofAmoxicillin Capsules,Clarithromycin Tabletsand LansoprazoleDelayed-ReleaseCapsules

02/28/2013

Amoxicillin/Clarithromycin/Omeprazole Capsule/Tablet/Capsule(Copackage)

Refer to USP formonographs ofAmoxicillin Capsules,Clarithromycin Tabletsand OmeprazoleDelayed-ReleaseCapsules

02/28/2013

Amoxicillin/Clavulanate Potassium Tablet Refer to USP As appropriate 0, 0.5, 1, 2, 3, 4 and5 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/AmphetamineSulfate/DextroamphetamineSaccharate/Dextroamphetamine Sulfate

Capsule (ExtendedRelease)

II (Paddle) 50 Dilute HCl, pH 1.1 forfirst 2 hrs, then add 200mL of 200 mMPhosphate Buffer andadjust to pH 6.0 for theremainder

0-2 hrs: 750 mL.After 2 hrs: 950 mL

0.5, 1, 2, 3, and 4hours

07/25/2007

Amphetamine Aspartate/AmphetamineSulfate/DextroamphetamineSaccharate/Dextroamphetamine Sulfate

Tablet I (Basket) 100 Deionized Water 500 10, 20, 30 and 45 11/25/2008

Amphetamine ER Capsule II (Paddle) 50 750 ml of dilute HCl, pH1.1 for the first 2 hours,then add 200 ml of 200mM phosphate buffer,and adjust to pH 6 (w/HCl or NaOH) for theremainder

750 ml of dilute HCl,200 ml of phosphatebuffer

1, 2, 3, 4, and 6hours

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 30and 45

01/03/2007

Apixaban Tablets Tablet II (Paddle) 75 0.05 M SodiumPhosphate Buffer with0.05% SLS, pH 6.8

900 5, 10, 20, 30 and45

05/09/2013

Aprepitant Capsule II (Paddle) 100 2.2% sodium dodecylsulfate in distilled water

900 10, 15, 20, 30 and45

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 (OrallyDisintegrating)

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/CodeinePhosphate

Capsule Refer to USP 08/27/2009

Aspirin/Caffeine/Orphenadrine Citrate Tablet I (Basket) 75 Water (deaerated) 900 10, 20, 30, 45 and60

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, 45and 60 min;Buffer:1, 2, 5, and 7hrs

10/09/2007

Aspirin/Hydrocodone Bitartrate Tablet II (Paddle) 75 Acetate Buffer, pH 4.5 900 10, 20, 30, 45, 60and 90

01/15/2004

Aspirin/Meprobamate Tablet I (Basket) 100 Water (deaerated) 900 10, 20, 30, 45, 60and 90

01/15/2004

Aspirin/Methocarbamol Tablet II (Paddle) 50 Water (deaerated) 900 10, 20, 30, 45, 60and 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% isopropanolbuffered to pH 8.0 withpotassium dihydrogenphosphate

900 10, 20, 30, 45, 60and 90

06/18/2007

Atovaquone Oral Suspension Develop a dissolutionmethod

07/21/2009

Atovaquone/Proguanil HCl Tablet II (Paddle) withPEAK vessels

50 40% isopropranolbuffered to pH 8.0 withpotassium dihydrogenphosphate

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

Azathioprine Tablet Refer to USP 04/08/2010 Azilsartan Kamedoxomil Tablet II (Paddle) 50 Phosphate Buffer, pH

7.8 (deaerated) 900 5, 10, 15, 20, 30

and 45 05/09/2013

Azilsartan Kamedoxomil/Chlorthalidone Tablet II (Paddle) 50 Phosphate Buffer, pH6.8 containing 1.0%Tween 80,

900 5, 10, 15, 20, 30and 45

05/09/2013

Azithromycin Suspension (ExtendedRelease)

II (Paddle) 50 Phosphate Buffer, pH6.0

900 15, 30, 45, 60, 120and 180

04/15/2008

Azithromycin Oral Suspension II (Paddle) 50 Phosphate buffer, pH6.0

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 (OrallyDisintegrating)

II (Paddle) 25 50 mM Acetate Buffer,pH 4.5

500 mL (10 mg) or1000 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 and45

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 01/16/2004

Betamethasone Acetate/BetamethasoneSodium Phosphate

Injectable Suspension IV (Flow throughcell)

Flow @ 8 mL/min 0.05% SLS, pH 3.0 orDevelop an in vitrorelease method usingUSP IV (Flow-ThroughCell), and, if applicable,Apparatus II (Paddle) orany other appropriatemethod, for comparativeevaluation by theAgency

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 Mphosphate buffer, pH 7.5Tier 2 Medium: 0.5%HDTMA in 0.05 M

900 15, 30, 45 and 60 08/17/2006



phosphate buffer, pH 7.5with 0.05 g/L pancreatinenzyme

Bicalutamide Tablet II (Paddle) 50 1% SLS in water 1000 10, 20, 30, 45 and60

12/15/2005

Bismuth SubcitratePotassium/Metronidazole/Tetracycline HCl

Capsule II (Paddle) 75 Tetracycline andMetronidazole: 0.1 NHCl; Bismuth SubcitratePotassium: Water

900 5, 15, 20, 30 and45

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) withsinker

50 50 mM phosphatebuffer, pH 6.8 with 0.1%sodium dodecyl sulfate

900 10, 20, 30, 45, 60and 75

01/31/2013

Bosentan Tablet II (Paddle) 50 1% SLS in water 900 15, 30, 45 and 60 09/02/2010 Brinzolamide Ophthalmic

Suspension Develop a method to

characterize in vitrorelease

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: PhosphateBuffer, 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) withadapter, ifneeded

50 0.9% Sodium Chlorideat 32C

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, anduntil at least 80% ofthe labeled contentis dissolved

04/09/2007

Buprenorphine HCl/Naloxone HCl Film (Sublingual) V (Paddle overDisk) with 56mm, 40 meshstainless steeldisk.

100 Acetate Buffer, pH4.0 (12.5mM Sodiumacetate trihydrate and60mM glacial aceticacid. Adjust the pH withglacial acetic acid orammonium hydroxide).

900 1, 2, 3, 5, 7 and 10 10/31/2013

Buprenorphine HCl/Naloxone HCl Tablet (Sublingual) I (Basket) 100 Water 500 1, 3, 5, 7.5, 10, 15and 20

07/01/2010

Bupropion HCl Tablet (ExtendedRelease)


Bupropion HCl Tablet Refer to USP 08/15/2013 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 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 Capsule II (Paddle) 50 Water 900 5, 10, 15, 20 and30

07/21/2009

Calcium Acetate Tablet Refer to USP 01/14/2008 Candesartan Cilexetil (16 mg, 8 mg and 4mg)

Tablet II (Paddle) 50 0.35% Polysorbate 20 in0.05 M PhosphateBuffer, pH 6.5

900 10, 20, 30, 45 and60

06/20/2007

Candesartan Cilexetil (32 mg) Tablet II (Paddle) 50 0.70% Polysorbate 20 in0.05 M PhosphateBuffer, pH 6.5

900 10, 20, 30, 45 and60

06/20/2007

Candesartan Cilexetil/Hydrochlorothiazide(16/12.5 mg)

Tablet II (Paddle) 50 0.35% Polysorbate 20 inphosphate buffer pH 6.5

900 10, 20, 30, 45 and60

01/29/2010

Candesartan Cilexetil/Hydrochlorothiazide(32/12.5 mg and 32/25 mg)

Tablet II (Paddle) 50 0.70% Polysorbate 20 inphosphate buffer pH 6.5

900 15, 20, 30, 45 and60

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 (ExtendedRelease)


Carbamazepine Capsule (ExtendedRelease)

II (Paddle) 75 First 4 hours: DiluteAcid, pH 1.1. After 4hours: PhosphateBuffer, pH 7.5 with 0.1%sodium lauryl sulfate(SLS).

First 4 h: 900. After4 h: 900

1, 2, 4, 6, 8, 10 and12 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 12/23/2010

Carbidopa/Entacapone/Levodopa Tablet I (Basket) Carbidopa andLevodopa: 50;Entacapone: 125

For both Carbidopa andLevodopa: 0.1 N HCl,For Entacapone:Phosphate buffer pH5.5

Carbidopa andLevodopa: 750 ml.Entacapone: 900ml

10, 20, 30, 45 and60

01/03/2007

Carbidopa/Levodopa Tablet (ExtendedRelease)

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 PhosphateBuffer, pH 6.8

750 5, 10, 15, 20 and30

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 Tablet Refer to USP Carvedilol Phosphate Capsule (Extended

Release) II (Paddle) 100 0.1N HCl 900 1, 2, 4, 6, 8, 12, 18

and 24 hours 10/31/2013

Carvedilol Phosphate Capsule (ExtendedRelease)

II (Paddle) 100 0.1 N HCl 900 1, 4, 8, 12, 18 and24 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, pH6.8

900 5, 10, 15, 30 and45

07/25/2007

Cefdinir Suspension II (Paddle) 50 0.05 M Phosphatebuffer, pH 6.8

900 10, 20, 30 and 45 04/09/2007

Cefditoren Pivoxil Tablet II (Paddle) 75 Simulated Gastric Fluidwithout enzyme

900 5, 10, 15, 20 and30

01/15/2010

Cefixime Suspension II (Paddle) 50 0.05 M Phosphatebuffer, 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 PhosphateBuffer, pH 7.2

900 10, 20, 30, 45 and60

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

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 Mtribasic sodiumphosphate (pH 12) with1% SLS. Tier 2 InitialMedium: 750 mL ofsimulated gastric fluid,USP (includes pepsin);At 20 minutes, whilestirring, add 180 mL ofappropriateconcentrations of SLSsolution (for a finalconcentration of 1%SLS). Add about 70 mLof 1.2 N NaOH to adjustthe pH to 12.

Tier 1: 1000 mL Tier2: 750 mL (initial)1000 mL (final)

10, 20, 30, 45 and60

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 (ExtendedRelease)

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) withoption to use asinker

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(ReciprocatingCylinder)

27 dpm Row 1: Test Fluid 1(0.1N HCl) for 1st hour.Row 2: Test fluid 2(Phosphate Buffer, pH7.5) for 5th hour

Row 1: 250 mL.Row 2: 250 mL

1 hour for test fluid1, and 4 hours fortest fluid 2

07/25/2007

ChlorpheniramineMaleate/Ibuprofen/Pseudoephedrine HCl

Tablet II (Paddle) 50 0.05 M PhosphateBuffer, pH 6.5

900 10, 20, 30 and 45 02/20/2004

Chlorpheniramine Polistirex/HydrocodonePolistirex

Capsule (ExtendedRelease)

II (Paddle) 50 Simulated IntestinalFluid without enzyme

500 1, 4, 12, and 24hours

11/25/2008

Chlorpheniramine Polistirex/HydrocodonePolistirex

Extended Release OralSuspension

II (Paddle) 50 Simulated Gastric Fluid(SGF) at 37C 0.5C

495 1, 2, 3, 6, 8, 12, 16and 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, pH3.5 0.05; Buffer Stage:0.05 M SodiumPhosphate, pH 6.8 0.05


Acid stage: 120;Buffer stage: 15, 30,60, 90, 120, 240and 360

07/01/2010

Ciclopirox Topical Suspension Develop a method tocharacterize in vitrorelease

03/25/2010

Cilostazol Tablet II (Paddle) 75 0.3% SLS in water 900 15, 30, 45, 60 and90

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 900 10, 20, 30 and 45 03/25/2010



with 0.025% Brij35(polyoxyethylene laurylether), pH 4.5

Ciprofloxacin HCl Tablet Refer to USP 09/02/2010 Ciprofloxacin HCl Tablet (Extended

Release) I (Basket) 100 0.1 N HCl 900 1, 2, 4, and 7 hours

or until at least 80%released

01/14/2008

Ciprofloxacin HCl/Hydrocortisone Otic Suspension Develop a method tocharacterize in vitrorelease

09/01/2011

Ciprofloxacin/Ciprofloxacin HCl (AB) Tablet (ExtendedRelease)

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 PhosphateBuffer, pH 6.8

900 10, 20, 30, 45 and60

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, 25and 30

07/31/2013

Clobazam Tablet II (Paddle) 75 0.1N HCl (degassed) 900 10, 20, 30, 45 and60

10/31/2013

Clobazam Oral Suspension II (Paddle) 75 0.1N HCl (degassed) 900 5, 10, 15, 20 and30

10/31/2013

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) withsinker

50 Acid stage: 0.01 N HCl;Buffer stage: PhosphateBuffer, pH 7.0


Acid stage: 1 and 2hours; Buffer stage:1, 2, 4, 6, 10, 14and 16 hours

01/26/2012

Clonidine ( EQ. 0.17 mg and EQ. 0.26 mg) Tablet (ExtendedRelease)

II (Paddle) 50 500 mL 0.1N HCl for the1st hour, then add 400mL 0.27M SodiumPhosphate (Dibasic)buffer solution


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 (Orally

Disintegrating) II (Paddle 50 RPM (12.5 mg,

25 mg and 100 mg);75 RPM (150 mgand 200 mg)

pH 4.5 Acetate Buffer 900 5, 10, 15, 20, and30

06/09/2011

Clozapine Tablet Refer to USP 07/21/2011 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 invarious media such asdeionized water,simulated gastric fluidand simulated intestinalfluid.

10/28/2010

Cyclobenzaprine Capsule (ExtendedRelease)

II (Paddle) 50 0.1 N HCl 900 2, 4, 6, 8, 12, and16 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

Cycloserine Capsule Refer to USP 05/09/2013 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, 60and 90

01/14/2008

Cyclosporine (25 mg) (AB1) Capsule (Liquid filled) II (Paddle) 75 0.1 N HCl containing 4mg of N,N-dimethydodecylamine-N-oxide per mL

500 10, 20, 30, 45, 60and 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 withmodifieddiameter of 24.5mm) for 150 mgstrength:

100 0.01 N HCl (pH 2.0) 900 10, 20, 30, and 45 09/22/2011

Dalfampridine Tablet (ExtendedRelease)

II (Paddle) 50 Phosphate Buffer, pH6.8

900 0.5, 1, 2, 4, 6, 8, 10and 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 6.8with 0.1 N KOH or 0.1 NHCl

900 10, 20, 30, 40 and60

01/27/2004

Dapsone Tablet Refer to USP 12/23/2010



Darifenacin Hydrobromide Tablet (ExtendedRelease)

I (Basket) 100 0.01M HCl Comparativedissolution data shouldalso be provided in 900ml pH 4.5 buffer, pH 6.8buffer, and water usingApparatus I (Basket) at100 RPM.

900 1, 4, 8, 12, 16, 20and 24 hours

01/20/2006

Darunavir Ethanolate Tablet II (Paddle) 75 2% Tween-20 in 0.05 MSodium PhosphateBuffer, pH 3.0

900 10, 20, 30, and 45 09/13/2007

Dasatinib Tablet II (Paddle) 60 pH 4.0 Acetate buffercontaining 1% Triton X-100

1000 10, 15, 30 and 45 10/30/2009

Deferasirox Tablet (for OralSuspension)

II (Paddle) 50 Phosphate buffer pH 6.8with 0.5% Tween 20

900 10, 20, 30 and 45 06/21/2006

Delavirdine Mesylate Tablet II (Paddle) 50 0.05 M PhosphateBuffer, pH 6.0 containing0.6% w/v SDS

900 10, 20, 30, 45 and60

12/03/2007

Demeclocycline HCl Capsule Refer to USP 07/25/2007 Demeclocycline HCl Tablet Refer to USP 07/25/2007

Desipramine HCl Tablet Refer to USP 01/31/2013 Desloratadine Tablet II (Paddle) 50 0.1 N HCl 500 15, 20, 30 and 45 03/04/2006 Desloratadine Tablet (Orally

Disintegrating) II (Paddle) 50 0.1 N HCl 900 3, 6, 10, 15 06/18/2007

Desloratadine/Pseudoephedrine Sulfate(2.5 mg/120 mg)

Tablet (ExtendedRelease)

II (Paddle) 50 First hour: 0.1 N HCl;After 1 hour: 0.1MPotassium PhosphateBuffer pH 7.5

1000 For Desloratadine:10, 20, 30 and 45;ForPseudoephedrineSulfate: 1, 2, 6 and8 hours

04/02/2009

Desloratadine/Pseudoephedrine Sulfate (5mg/240 mg)


II (Paddle) 50 First hour: 0.1 N HCl;After 1 hour: 0.1MPotassium PhosphateBuffer pH 7.5

1000 For Desloratadine:10, 20, 30 and 45;ForPseudoephedrineSulfate: 1, 2, 4, 8,16 and 24 hours

04/02/2009

Desmopressin Acetate Tablet II (Paddle) 75 Water (deaerated) 500 10, 20, 30 and 45 12/15/2005 Desogestrel/Ethinyl Estradiol Tablet Refer to USP 11/04/2008 Desvenlafaxine Succinate Tablet (Extended

Release) I (Basket) 100 0.9% NaCl in water 900 1, 2, 4, 8, 12, 16, 20

and 24 hours 04/02/2009

Dexamethasone Implant (Intravitreal) VII (withreciprocating 50mesh baskets)

30 cycles per min Phosphate BufferedSaline containing 0.05g/L sodium dodecylsulfate at 45 0.5C

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



04/02/2009

Dexlansoprazole Capsule (DelayedRelease)

I (Basket) 100 Acid Stage: 0.1 N HCl,Buffer Stage: pH 7.0Phosphate Buffer with 5mM SLS


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, pH6.8

Acid: 500, Buffer:500

0.5, 1, 2, 4, 6, and10 hours

01/14/2008

Dextroamphetamine Sulfate Capsule (ExtendedRelease)

I ( Basket) 100 0.1 N HCl 500 1, 4, 8 and 12hours

11/25/2008

Dextroamphetamine Sulfate Tablet I (Basket) 100 Water 500 10, 20, 30, 45 and60

01/31/2013

Dextromethophan HBr/Guaifenesin Tablet (ExtendedRelease)

I (Basket) 50 0.01 N HCl 900 1, 2, 6, and 12hours

11/25/2008

Dextromethorphan Hydrobromide/QuinidineSulfate

Capsule I (Basket) 100 pH 1.2, SimulatedGastric Fluid withoutenzyme

900 5, 10, 15, 20 and30

01/05/2012

Dextromethorphan Polistirex Suspension (ExtendedRelease)

II (Paddle) 50 0.1 N HCl 500 30, 60, 90 and 180 10/06/2008

Diazepam Tablet Refer to USP 07/25/2007 Diazepam Gel (Rectal) II (Paddle) 50 0.05 M Phosphate

Buffer, pH 6.8 500 5, 10, 15, 30 and

45 04/02/2009

Diazoxide Oral Suspension Develop a dissolutionmethod

Diclofenac Epolamine Topical patch V (Paddle overDisk) with awatchdish (adiameter of 6cm)

50 pH 6.8 phosphate bufferat 32 0.5C

500 15, 30, 45, 60, 90,120 and 180

10/21/2010

Diclofenac Potassium Powder forOral Solution

II (Paddle 75 0.05M phosphate buffer(TriSodium PhosphateDodecahydrate in 0.1 NHCl and pH adjusted to6.8)

400 2.5, 5, 7.5 and 10 10/21/2010

Diclofenac Potassium Capsule II (Paddle 50 50 mM Phosphate bufferpH 6.8

900 10, 15, 20, 30 and45

10/21/2010

Diclofenac Potassium Tablet II (Paddle) 50 SIF without enzyme 900 10, 20, 30, 45, 60and 90

01/27/2004

Diclofenac Sodium Tablet (ExtendedRelease)


Diclofenac Sodium Tablet (DelayedRelease)




Diclofenac Sodium/Misoprostol EntericCoated

Tablet (DelayedRelease)

II (Paddle)(diclo) II(Paddle) (miso)

100 (diclo) 50(miso)

Diclofenac: Acid Stage:0.1 N HCl Buffer Stage:750ml 0.1N HCL+250ml0.2M phos.buffer, pH 6.8(Method A) Misoprostol:Water (deaerated)

Diclo: Acid: 750Buffer:1000 Miso:500

Diclo.: 120 (acid)15, 30, 45 and 60(Buffer). Miso:10, 20and 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 NHCl:0.2M TribasicSodium Phosphate(3:1), pH 6.8

1000 Acid stage: 60, 90and 120; Bufferstage: 10, 20, 30,45 and 60

01/26/2004

Dienogest/Estradiol Valerate Tablet II (Paddle) 50 0.4% SLS in water 900 10, 15, 20, 30 and45

06/07/2012

Diethylpropion HCl Tablet (ExtendedRelease)

I (Basket) 100 Water (deaerated) 900 1, 3, 5, 7 and 9hours

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 (ExtendedRelease)






Dinoprostone Vaginal Suppository Develop a method tocharacterize in vitrorelease

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 5hours

09/01/2011

Diphenhydramine Citrate/Ibuprofen Tablet II (Paddle) 50 50 mM PhosphateBuffer, pH 6.5

900 10, 20, 30 and 45 01/14/2008

Diphenhydramine HCl/Ibuprofen Capsule I (Basket) 100 200 mM PhosphateBuffer, 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


Disulfiram Tablet II (Paddle) 100 2% SDS 900 15, 30, 45, 60, 75,90, 105, and 120

06/18/2007

Divalproex Sodium Tablet (DelayedRelease)


Divalproex Sodium Capsule (DelayedRelease Pellet)

II (Paddle) 50 0.05 M PhosphateBuffer, pH 7.5

500 2, 4, 6, 8 and 10hrs

10/06/2008

Divalproex sodium Tablet (ExtendedRelease)

II (Paddle) 100 Acid phase: 0.1 N HClfor 45 minutes; DrugRelease: (after 45minutes) 0.05 MPhosphate Buffer with75 mM SDS, pH 5.5

Acid phase:500 mL;Drug release: 900mL

1.5, 3, 6, 9, 12, 15,18, 21 and 24hours

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 (ExtendedRelease)

II (Paddle) 75 SGF without enzyme 900 1, 2, 4, 6, 8, 12 and16 hours

01/03/2007

Doxazosin Mesylate Tablet II (Paddle) 50 0.01 N HCl 900 10, 20, 30, 45 and60

01/27/2004

Doxepin HCl Tablet II (Paddle) 50 Simulated Gastric Fluidw/o enzyme (pH 1.1-1.3)

900 5, 10, 15, 20, 30and 45

09/02/2010

Doxepin HCl Capsule Refer to USP 08/05/2010 Doxercalciferol Capsule Develop a quantitative

rupture test 06/03/2008

Doxorubicin HCl Injectable (Liposomal) Develop a method tocharacterize in vitrorelease, starting at pH6.00 0.05 and at 47C 0.5C. Replicate for 12dosage vials.

10/04/2012

Doxycycline Capsule (DelayedRelease)

II (Paddle) 75 Dilute HCl, pH 1.1 for 2hours and then add 200mL of 0.1 N NaOH in200 mM PhosphateBuffer. Adjust pH to 6.0using 2 N HCl and/or 2NNaOH


1, 2, 2.5 , 3 and 4hours

10/06/2008

Doxycycline Suspension II (Paddle) 25 0.01 N HCl 900 5, 10, 15 and 20 09/03/2008 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 (DelayedRelease)

I (Basket) 50 Acid stage: 0.06 N HCl;Buffer stage: NeutralizedPhthalate Buffer, pH5.5


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 USPcapsule rupture testshould also beconducted)

500 5, 10, 15, 30, 45,60, and until at least80% of the labeledcontent is released

01/31/2007

Dronedarone HCl Tablet II (Paddle) 75 pH 4.5 Phosphatebuffer

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 09/22/2011 Drospirenone/EthinylEstradiol/Levomefolate Calcium

Tablet II (Paddle) 50 Phosphate BufferedSaline pH 6.8 containing0.03% ascorbic acid

900 5, 10, 15, 20, 30and 45

01/05/2012

Duloxetine HCl Capsule (DelayedRelease Pellets)

I (Basket) 100 [A] Gastric Challenge:0.1N HCl [B] BufferMedium: pH 6.8phosphate buffer (USP)

1000 120 minutes (For A)15, 30, 45, 60 and90 minutes (For B)

03/22/2006

Dutasteride Capsule (Soft-Gelatin) II (Paddle) 50 Tier I: DissolutionMedium: 0.1 N HCI with2% (w/v) sodiumdodecyl sulfate (SDS)(900 mL) Tier II:Dissolution Medium: 0.1N HCI with pepsin (asper USP) (450 mL) forthe first 25 minutes,followed by addition of0.1 N HCI with SDS (4%w/v) (450 mL) for theremainder of thedissolution test.

900 15, 30, 45 and 60 08/05/2010

Dutasteride/Tamsulosin HCl Capsule Dutasteride: II(Paddle) withsinker.Tamsulosin: II(Paddle)

Dutasteride: 75Tamsulosin: 50

Dutasteride::Tier I:Dissolution Medium:1%w/vcetyltrimethylammoniumbromide (CTAB) in 0.1 NHCl. Tier II: DissolutionMedium: 1% w/v CTABin 0.1 N HCl with 0.16%w/v pepsin.TamsulosinAcid Stage(0-2 hrs): 0.1 N HCl.Buffer stage: Add 250mL of 0.2 M SodiumPhosphate Tribasic,Dodecahydrate pH 6.8

Dutasteride: 900.Tamsulosin: Acidstage: 750; Bufferstage: 1000

Dutasteride: 15, 30,45 and 60 minutes.Tamsulosin: AcidStage: 2 hoursBuffer stage: 0.5, 1,2, 3, 5, 7 and 10hours

01/26/2012

Efavirenz Capsule II (Paddle) Asinker may beused withjustification ifnecessary.

50 1% Sodium LaurylSulfate 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, pH6.8

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 containingPepsin 750,000 USPunits/L. Tier 2 is usedafter failure of Tier 1testing

900 10, 20, 30 and 45 12/16/2005

Emtricitabine/Tenofovir DisoproxilFumarate

Tablet II (Paddle) 50 0.01 N HCl 900 5, 10, 15, 30 and45

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

Ergocalciferol Capsule II (Paddle) 100 0.5 N NaOH with 10%Triton-X-100

500 15, 30, 45, 60 and90

08/05/2010

Erlotinib HCl Tablet II (Paddle) 75 0.1 N HCl containing 1%SDS

1000 15, 30, 45 and 60 03/22/2006

Erythromycin Tablet (DelayedRelease)


Erythromycin Ethylsuccinate Suspension II (Paddle) 75 Monobasic SodiumPhosphate, pH 6.8Buffer with 1% SLSBuffer w/ 1% SLS

900 10, 20, 30, 45 and60

01/27/2004

Erythromycin Ethylsuccinate/SulfisoxazoleAcetyl

Granules for Oralsuspension

Develop a dissolutionmethod

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: SodiumAcid stage: 300;Buffer stage: 1000

Acid stage: 120;Buffer stage: 10, 20,

02/26/2004



Phosphate Buffer, pH6.8

30, 45 and 60

Esomeprazole Magnesium For Oral Suspension(Delayed Release)

II (Paddle 100 Acid stage: 0.1 N HCl;Buffer stage: SodiumPhosphate Buffer, pH6.8


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, pH4.75 0.05

500 1, 2, 3, 5, 8, 10 and12 hours

07/21/2009

Estradiol Vaginal Ring Incubatorshaker

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 tocharacterize in vitrorelease

10/28/2010

Estradiol (0.025 mg/24 hr, 0.0375 mg/24hr, 0.05 mg/24 hr, 0.06 mg/24 hr, 0.075mg/24 hr and 0.1 mg/24 hr)

Film, Transdermal(Extended Release)

Develop a method tocharacterize in vitrorelease

10/28/2010

Estradiol (Test 1) (0.025 mg/24 hr, 0.0375mg/24 hr, 0.05 mg/24 hr, 0.075 mg/24 hrand 0.1 mg/24 hr)


VI(Cylinder) attachthe patch to adisk at thebottom of thecylinder

50 Water at 32 0.5C 0.025 mg/24 hr and0.0375 mg/24 hr:500 mL; 0.05 mg/24hr, 0.075 mg/24 hrand 0.1 mg/24 hr:900 mL

1, 2, 4, 6, 8, 10 and12 hours

10/28/2010

Estradiol (Test 2) (0.05 mg/24 hr and 0.1mg/24 hr)


V (Paddle overDisk) with astainless steeldisk

50 Water at 32 0.5C 900 6, 12, 18, 24, 36,48, 60, 72 and 96hours

10/28/2010

Estradiol (Test 3) 0.0375 mg/24 hr, 0.05mg/24 hr, 0.075 mg/24 hr and 0.1 mg/24hr)


VI(Cylinder) attachthe patch to thecylinder withdouble-sidedtape

50 Water at 32 0.5C 0.0375 mg/24 hr:500 mL; 0.05 mg/24hr, 0.075 mg/24 hrand 0.1 mg/24 hr:900 mL

1, 2, 4, 6, 10, 12,18, 24 and 36hours

10/31/2013

Estradiol/Norethindrone Acetate Tablet Refer to USP 01/05/2012 Estradiol/Norgestimate (1mg/0.09mg) Tablet II (Paddle) 50 0.3% SLS in water 500 10, 20, 30 and 45 07/09/2004 Estramustine Phosphate Sodium Capsule I (Basket) 100 Water 900 10, 20, 30 and 45 07/15/2009 Estrogens Conjugated Synthetic A Tablet I (Basket) 50 Water 900 1, 2, 3, 5, 8, 10 and

12 hours 09/02/2010

Estrogens, Conjugated Synthetic B Tablet II (Paddle) 50 Water 900 2, 5, 8 and 12hours

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 tocharacterize in vitrorelease

01/31/2013

Ethinyl Estradiol/Levonorgestrel Tablet Refer to USP 02/19/2008 Ethinyl Estradiol/Levonorgestrel (AB) Tablet Refer to USP 02/19/2008 Ethinyl Estradiol/Levonorgestrel (AB2) Tablet Refer to USP 11/04/2008 Ethinyl Estradiol/Norethindrone Tablet (Chewable) II (Paddle) 75 0.09% Sodium Lauryl

Sulfate in 0.1 N HCl 500 10, 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 inwater

600 10, 20, 30 and 45 01/14/2008

Ethinyl Estradiol/Norgestrel Tablet II (Paddle) 75 Water with 5 ppm ofTween 80

500 10, 20, 30, 45, 60and 90

01/28/2004

Ethinyl Estradiol; Norelgestromin Film, Transdermal Modified USPType V (Paddle-over-disk)

50 0.1% Hydroxypropyl-beta-cyclodextrin at 32C

900 0.25, 0.5, 1, 2, 4, 8,12, 16, 20 and 24hours

05/20/2009

Ethionamide Tablet I (Basket) 75 0.1N HCl 900 10, 20, 30, 45 and60

01/31/2013

Ethosuximide Capsule Refer to USP 04/15/2008 Etidronate Disodium Tablet Refer to USP 06/18/2007 Etodolac Tablet (Extended


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 MHCl in two phases:Phase 1: 500 mL ofdegassed 0.01 M HClfor 10 minutes. Phase 2:Add 400 mL of 2.25%SLS in 0.01 M HCl.

500 (phase 1): 900(phase 2)

Phase 1: NoSampling. Phase 2:5, 10, 20, 30, 45, 60and 90

06/30/2011

Etravirine (200 mg) Tablet II (Paddle) 70 1.0 % Sodium laurylsulfate (SLS) in 0.01 MHCl in two phases:Phase 1: 1000 mL ofdegassed 0.01 M HClfor 10 minutes. Phase 2:Add 800 mL of 2.25%SLS in 0.01 M HCl.

1000 (phase 1):1800 (phase 2)

Phase 1: NoSampling. Phase 2:5, 10, 20, 30, 45, 60and 90

06/30/2011



Everolimus Tablet II (Paddle) 50 Water with 0.4% sodiumdodecylsulfate

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 SodiumPhosphate, 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 and30

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 and60

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/MagnesiumHydroxide

Tablet (Chewable) Develop a dissolutionmethod

12/15/2009

Famotidine/Ibuprofen Tablet II (Paddle) 50 0.05 M PhosphateBuffer, pH 7.2

900 5, 10, 15, 20, 30and 45

08/15/2013

Febuxostat Tablet II (Paddle) 75 0.05 M PhosphateBuffer, pH 6.0

900 5, 10, 15, 20 and30

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


Fenofibrate Capsule (Micronized) II (Paddle) 75 0.025 M SLS in water 1000 10, 20, 30, 40 and60

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, 90and 120

02/19/2008

Fenofibrate (40 mg and 120 mg) Tablet II (Paddle 75 0.75% Sodium laurylsulfate in water

900 5, 10, 20, 30, 45and 60

10/21/2010

Fenofibrate (48 mg and 145 mg) Tablet II (Paddle 50 25 mM Sodium laurylsulfate in water

1000 5, 10, 20, 30, 45and 60

10/21/2010

Fenofibrate (54 mg and 160 mg) Tablet II (Paddle 50 0.05 M Sodium laurylsulfate in water

1000 5, 10, 20, 30, 45and 60

10/21/2010

Fenofibric Acid Tablet II (Paddle) 75 Phosphate buffer, pH6.8

900 5, 15, 30, 45 and60

08/05/2010

Fenoprofen Calcium Capsule Refer to USP 11/25/2008 Fentanyl Transdermal VII

(Reciprocatingholder)-cylinder.

30 cycles perminute. amplitude ofabout 2m.

Equimolar mixture of0.005 M phosphoric acidsolution, and 0.005 Msodium phosphate,monobasic monohydrate(pH ~ 2.6). at 32 C.Change the testsamples into fresh pre-equilibrated releasemedium at the timepoints indicated.Remove the protectiveliner and place the filmonto a piece of nylonnetting with adhesivefacing the net. Securethe netting andtransdermal systemusing nylon tie wraps atthe top and bottom ofthe cylinder on theholder. The adhesiveside faces towards themedia.

250 mL for the 75and 100 mcg/hr,200 mL for the 50mcg/hr and 150 mLfor the 25 and 12.5mcg/hr dosagestrength.

0.5, 1, 2, 4 and 24hours

06/09/2011

Fentanyl Citrate Tablet (Sublingual) II (Paddle) 50 Phosphate Buffer, pH6.8

500 1, 3, 5, 7, 10, 15and 20

08/15/2013

Fentanyl Citrate Lozenges II (Paddle) 175 0.1M Phosphate Buffer,pH 4.5

500 5, 10, 20, 30 and40

05/20/2009

Fentanyl Citrate (0.1 mg and 0.4 mg) Tablet (Buccal) II (Paddle) smallvolumedissolutionapparatus

100 Phosphate BufferedSaline solution, pH 7.0

100 3, 5, 7.5, 10, 15 and20

11/20/2009

Fentanyl Citrate (0.2 mg, 0.3 mg, 0.6 mgand 0.8 mg)

Tablet (Buccal) II (Paddle) smallvolumedissolutionapparatus

100 Phosphate BufferedSaline solution, pH 7.0

200 3, 5, 7.5, 10, 15 and20

11/20/2009

Fentanyl Citrate (0.2 mg, 0.4 mg, 0.6 mgand 0.8 mg)

Film (Buccal) I (Basket) 100mL dissolutionvessel

100 25-mM PhosphateBuffer, pH 6.4

60 5, 10, 15, 20, 30and 45

12/15/2009

Fentanyl Citrate (1.2 mg) Film (Buccal) I (Basket) 100mL dissolutionvessel

100 25-mM PhosphateBuffer, pH 6.4

100 5, 10, 15, 20, 30and 45

12/15/2009

Fesoterodine Fumarate Tablet (ExtendedRelease)

II (Paddle) withsinker

75 Phosphate Buffer, pH6.8

900 1, 2, 4, 6, 8, 10, 12,16 and 20 hours

08/15/2013

Fexofenadine HCl Tablet (OrallyDisintegrating)

II (Paddle) 50 0.001 N HCl 500 5, 10, 15, 30 and45

09/03/2008

Fexofenadine HCl Tablet II (Paddle) 50 0.001 N HCl 900 5, 10, 20, 30 and45

02/19/2004

Fexofenadine HCl Capsule II (Paddle) 50 Water (deaerated) 900 10, 20, 30, 45 and 01/29/2004



60 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


Finasteride Tablet Refer to USP 07/25/2007 Fingolimod Capsule I (Basket) 100 0.1 N HCl with 0.2%

SDS (sodium dodecylsulfate)

500 5, 10, 15, 20 and30

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 & 100mg tabs)

10, 20, 30, 45 and60

03/04/2006

Fluconazole (200 mg/5 mL) Suspension II (Paddle) 50 Water (deaerated) 900 10, 20, 30 and 45 01/30/2004 Fluconazole (50 mg/5 mL) Suspension II (Paddle) 50 Water (deaerated) 500 10, 20, 30 and 45 01/30/2004 Flucytosine Capsule Refer to USP 06/24/2010 Fludarabine Phosphate Tablet II (Paddle) 50 Water 900 5, 10, 15, 20 and

30 06/07/2012

Fludrocortisone Acetate Tablet Refer to USP 05/20/2009 Fluoxetine Capsules (Delayed


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


6.8 900 1, 2, 4, 6, 8 and 12

hours 01/15/2010

Fosamprenavir Calcium Tablet II (Paddle) 75 250 mM SodiumAcetate/Acetic acidbuffer pH 3.5

900 10, 20, 30 and 45 12/16/2005

Fosamprenavir Calcium Oral Suspension II (Paddle) 25 10 mM HCl 900 5, 10,15 and 20 12/03/2007 Fosinopril Sodium Tablet II (Paddle) 50 Water (deaerated) 900 10, 20, 30 and 45 01/30/2004 Fosinopril Sodium/Hydrochlorothiazide Tablet Refer to USP 08/11/2008 Frovatriptan succinate Tablet II (Paddle) 50 Phosphate Buffer pH

5.5 900 5, 10, 15, 20 and

30 11/04/2008

Furosemide Tablet Refer to USP 08/05/2010 Gabapentin Tablet Refer to USP 06/03/2008 Gabapentin Capsule Refer to USP 06/03/2008 Gabapentin Enacarbil Tablet (Extended

Release) II (Paddle) 50 10 mM Phosphate buffer

at pH 7.4 with 1.0 %SLS

500 (for 300 mg);900 (for 600 mg)

0.5, 1, 2, 4, 6, 8, 12and 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 phosphatebuffer pH 6.5Comparative dissolutiondata should also beprovided in 900 ml pH0.1 HCl, pH 4.5 buffer,and water usingApparatus II (Paddle) at50 RPM.

900 1, 4, 10 and 12hours

01/20/2006

Ganciclovir Capsule II (Paddle) 60 Water (deaerated) 900 10, 20, 30, 45 and60

02/02/2004

Gefitinib Tablet II (Paddle) 50 Tween 80 (5% v/v) inwater

1000 10, 20, 30, 45 and60

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: pH2.0, HCl Buffer. ForGlimepiride: pH 6.8,Sodium PhosphateBuffer with 0.2% sodiumdodecyl sulfate

900 For Pioglitazone:10, 15, 20, 30 and45; 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 DodecylSulfate

900 5, 10, 15, 30, 45and 60

01/03/2007

Glipizide Tablet (ExtendedRelease)

II (Paddle) 50 Simulated IntestinalFluid without pancreatin,pH 7.5

900 1, 2, 4, 8, 16 hoursand until at least80% dissolved

04/10/2008

Glipizide Tablet Refer to USP 08/05/2010 Glipizide/Metformin HCL Tablet Refer to USP 12/18/2008 Glyburide (Micronized) Tablet II (Paddle) 50 0.05 M Phosphate

Buffer, pH 7.5 900 10, 20, 30, 45 and

60 02/02/2004

Glyburide (Non-micronized) Tablet II (Paddle) 75 0.05 M Borate Buffer,pH 9.5

500 10, 20, 30, 45 and60

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, thejar is removedfrom incubationandmechanically

Swirl orbit of 50 mmat 205 rpm for 6seconds

Each implant should beincubated in 50 mL ofphosphate bufferedsaline, pH 7.4, at 39C(warmed overnightbefore the implants are

50 3, 14, 35, 56 and 84days (10.8 mgstrength); 7, 14, 17,21 and 28 days (3.6mg strength)

11/04/2008



swirled withdigital orbitalshaker

added), in a 120-mLWheaton jar.

Granisetron Film, Transdermal(Extended Release)

VI (Cylinder) 50 80 microL /L phosphoricacid (85%) at 32 0.5C

1000 2, 6, 12, 24, 36, 48,60, 72 and 96hours

03/03/2011

Granisetron HCl Tablet II (Paddle) 50 Phosphate buffer, pH6.5

500 10, 20, 30, 45 and60

06/05/2006

Griseofulvin Oral Suspension II (Paddle) 25 and 50 0.54% Sodium LaurylSulfate (SLS) in Water

1000 10, 20, 30 and 45 10/28/2010

Griseofulvin (Microcrystalline) Oral Suspension II (Paddle) 25 and 50 0.54% Sodium LaurylSulfate (SLS) in Water

1000 10, 20, 30 and 45 10/28/2010

Griseofulvin (Microcrystalline) Tablet Refer to USP 01/15/2010 Griseofulvin (Ultramicrocrystalline) Tablet Refer to USP 11/04/2008 Guaifenesin Tablet (Extended

Release) I (Basket) 75 0.1 N HCl 900 1, 2, 4, 6 and 12

hours 01/03/2007

Guaifenesin/PseudoephedrineHydrochloride


I (Basket) 50 0.01 N HCl 900 1, 2, 6, and 12hours

11/25/2008

Guanfacine Tablet (ExtendedRelease)

II (Paddle) 75 HCl Buffer, pH 2.2 900 1, 2, 4, 6, 8, 10, 12,16, 20 and 24hours

07/01/2010

Haloperidol Tablet Refer to USP 11/25/2008 Homatropine Methylbromide/HydrocodoneBitartrate

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 and60

02/03/2004

Hydrochlorothiazide/Metoprolol Succinate Tablet (ExtendedRelease)

II (Paddle) Hydrochlorothiazide:100; Metoprololsuccinate: 75

Hydrochlorothiazide:0.1N HCl; Metoprololsuccinate: PhosphateBuffer, pH 6.8

Hydrochlorothiazide:500; Metoprololsuccinate: 500

Hydrochlorothiazide:10, 15, 20, 30, and45 minutes;Metoprololsuccinate: 1, 2, 4,6, 8, 12, 16, 20 and24 hours

10/31/2013

Hydrochlorothiazide/Metoprolol Tartrate Tablet Refer to USP 01/05/2012 Hydrochlorothiazide/Moexipril HCl Tablet II (Paddle) 50 0.1 N HCl 900 5, 10, 15 and 30 02/10/2004 Hydrochlorothiazide/OlmesartanMedoxomil

Tablet II (Paddle) 50 0.05 M PhosphateBuffer, pH 6.8

900 5, 10, 15, 20, 30, 45and 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

Hydrocortisone Tablet Refer to USP 05/09/2013

Hydromorphone HCl Tablet (ExtendedRelease)

VII(Reciprocatingholder) (Sampleholder-Cage)

30 cycles per min Water 50 1, 2, 4, 6, 8, 10, 12,16, 20 and 24hours

05/09/2013

Hydromorphone HCl Tablet Refer to USP 07/25/2007 Hydroxyurea Capsule Refer to USP 09/03/2008 Hydroxyzine HCl Tablet Refer to USP 07/25/2007 Hydroxyzine Pamoate Capsule Refer to USP 04/02/2009 Hydroxyzine Pamoate Suspension Develop a dissolution

method 04/02/2009

Ibandronate Sodium Tablet II (Paddle) 50 Water 500 5, 10, 15, 30 and45

01/03/2007

Ibuprofen Tablet Refer to USP 07/25/2007 Ibuprofen Tablet (Chewable) II (Paddle) 50 0.05 M Phosphate

Buffer, pH 7.2 900 10, 20, 30 and 45 02/04/2004

Ibuprofen Suspension Refer to USP 11/04/2008 Ibuprofen Suspension/Drop II (Paddle) 50 Phosphate Buffer, pH

7.2 900 5, 10, 15 and 20 11/04/2008

Ibuprofen Capsule (Soft-Gelatin/Liquid Fill)

I (Basket) 150 50mM PhosphateBuffer, pH 7.2

900 5, 10, 20, 30 and45

05/09/2013

Ibuprofen Potassium Capsule (Soft-Gelatin/Liquid Fill)

I (Basket) 150 Phosphate Buffer, pH7.2

900 5, 10, 20 and 30 02/04/2004

Ibuprofen/Diphenhydramine Capsule I (Basket) 100 Phosphate Buffer (200mM), pH7.2

900 10, 20, 30 and 45 01/03/2007

Ibuprofen/Oxycodone HCl Tablet I (Basket) 100 Phosphate buffer, pH7.2

500 10, 20, 30 and 45 04/09/2007

Ibuprofen/Phenylephrine HCl Tablet II (Paddle) 50 50 mM PotassiumPhosphate Buffer, pH6.5, (degassed)

900 10, 15, 20, 30 and45

01/05/2012

Ibuprofen/Pseudoephedrine HCl Capsule I (Basket) 150 Tier 1: 0.05 Mphosphate buffer, pH 7.2Tier 2: 0.05 Mphosphate buffer, pH 7.2with NMT 1750 USPprotease units/L of 1 XUSP pancreatin

900 10, 20, 30 and 45 03/04/2006

Ibuprofen/Pseudoephedrine HCl Suspension II (Paddle) 50 0.05 M PhosphateBuffer, pH 7.2

900 5, 10, 15 and 30 02/04/2004



Icosapent Ethyl Capsule Develop an in vitrorelease method usingUSP IV (Flow-ThroughCell), and, if applicable,Apparatus II (Paddle) orany other appropriatepharmacopoeialapparatus, forcomparative evaluationby the Agency.

08/15/2013

Iloperidone Tablet II (Paddle) 50 0.1 N HCl 500 5, 10, 15, 30, 45and 60

08/05/2010

Imatinib Mesylate Tablet II (Paddle) 50 0.1 N HCl 1000 5, 10, 15, 20 and30

09/22/2011

Imipramine HCl Tablet Refer to USP 01/14/2008 Imipramine Pamoate Capsule I (Basket) 100 0.1 N HCl without

pepsin and with 0.3%pepsin (addition ofpepsin is recommendedonly when significantslow dissolution isobserved)

900 30, 60, 90, 120, 150and 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 (ExtendedRelease)


Indomethacin Capsule Refer to USP 12/15/2009 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 Dinitrate/Hydralazine HCl Tablet I (Basket) 100 0.05 N HCl 900 10, 15, 20, 25, 30

and 45 06/10/2009

Isosorbide Mononitrate Tablet (ExtendedRelease)


Isosorbide Mononitrate Tablet II (Paddle) 50 Water (deaerated) 900 5, 10, 15 and 30 02/04/2004 Isotretinoin Capsule I (Basket, with

20 mesh) 100 0.05 M Potassium

Phosphate Buffer,dibasic, pH 7.8,containing 0.5% solidLDAO

900 15, 30, 45, 60 and90

10/06/2008

Isradipine Capsule II (Paddle) 50 0.1% LaurylDimethylamine Oxide(LDAO) in water

500 10, 20, 30, 45 and60

02/25/2004

Isradipine (10 mg) Tablet (ExtendedRelease)

II (Paddle) 50 0.2% LaurylDimethylamine Oxide(LDAO) in water

1000 2, 4, 8, 12, 16 and24 hours

02/25/2004

Isradipine (5 mg) Tablet (ExtendedRelease)

II (Paddle) 50 0.2% LaurylDimethylamine Oxide(LDAO) in water

500 2, 4, 8, 12, 16 and24 hours

02/25/2004

Itraconazole Capsule II (Paddle) 100 SGF without Enzyme 900 10, 20, 30, 45, 60and 90

02/04/2004

Itraconazole Tablet II (Paddle) 75 0.1 N HCl 900 5, 15, 30, 45, 60, 75and 90

08/15/2013

Ivermectin Tablet II (Paddle) 50 0.5% SDS in 0.01 MMonobasic SodiumPhosphate, pH 7.0

900 10, 20, 30, 45 and60

02/04/2004

Ketoconazole Tablet I (Basket) 100 Simulated gastric fluidw/o pepsin

800 15, 30, 45, 60 and90

01/03/2007

Ketoprofen Tablet II (Paddle) 50 SIF Buffer withoutenzyme, pH 7.4

900 10, 20, 30, 45 and60

02/05/2004

Ketoprofen Capsule II (Paddle) 50 0.05 M PhosphateBuffer pH 7.4

1000 10, 20, 30 and 45 07/25/2007

Ketorolac Tromethamine Tablet Refer to USP 04/15/2008 Labetalol HCl Tablet Refer to USP 08/27/2009 Lacosamide Tablet II (Paddle) 50 0.1 N HCl 900 10, 15, 20, 30 and

45 06/07/2012

Lamivudine (for 100 mg & 150 mg) Tablet II (Paddle) 50 Water (deaerated) 900 10, 20, 30 and 45 03/22/2006 Lamivudine (for 300 mg only) Tablet II (Paddle) 75 0.1 N HCl 900 5, 10, 15 and 30 03/22/2006 Lamivudine 150 mg/Zidovudine 300mgTablets and Abacavir Sulfate 300 mgTablets-co-packaged

Tablet II (Paddle) 75 0.1 N HCl 900 5, 10, 15, 20, 30and 40

01/03/2007

Lamivudine/Stavudine/Nevirapine Tablet II (Paddle) 75 0.1 N HCl 900 10, 20, 30, 45 and60

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: 75Efavirenz: 50

Lamivudine andZidovudine: 0.1 N HClEfavirenz: 2% SLS inwater

Lamivudine andZidovudine: 1000Efavirenz: 900

10, 20, 30, and 45 01/03/2007

Lamivudine/Zidovudine + Nevirapine Tablet (Copackage) II (Paddle) 50 Lamivudine andZidovudine: waterNevirapine: 0.06 M HCl(pH 1.2)

900 10, 15, 30, 45 and60

01/03/2007

Lamivudine/Zidovudine/ Nevirapine Tablet II (Paddle) 50 0.01 N HCl 900 10, 15, 30, 45 and60

01/03/2007

Lamotrigine Tablet (Regular) II (Paddle) 50 0.1 N HCl 900 5, 10, 15, 20 and30

03/04/2006

Lamotrigine Tablet (Chewabledispersible)

II (Paddle) 50 0.1 N HCl 900 5, 10, 15, 20 and30

01/14/2008

Lamotrigine Tablet (Extended II (Paddle) 50 Acid Stage: 0.01M HCl; Acid Stage: 700; Acid stage: 120; 03/25/2010



Release) Buffer Stage: PhosphateBuffer, pH 6.8 + 0.5%SLS (Add 200 mL of0.0205M tribasic sodiumphosphate (pH 12)solution containing2.25% w/v SLS to 700mL of HCl)

Buffer Stage: 900 Buffer stage: 1, 2, 3,5, 7, 10, 12 and 15hours

Lansoprazole Capsule (DelayedRelease)


Lansoprazole Tablet (DelayedRelease, OrallyDisintegrating)

II (Paddle) 75 Acid Stage: 0.1 N HCl;Buffer Stage: PhosphateBuffer, pH 6.8 with 5mM Sodium DodecylSulfate

500 (Acid), 900(Buffer)

60 (Acid), 10, 20, 30and 45 (Buffer)

11/04/2008

Lanthanum Carbonate Chewable Tablet ReciprocatingCylinder(Apparatus 3modified)

10 dpm (dip rate perminute)

0.25 N HCl 900 (modified fromthe standardapparatus 3 vesselto achieve sinkcondition)

10, 20, 30 and 45 01/03/2007

Lapatinib Ditosylate Tablet II (Paddle) 55 2% Polysorbate 80 in0.1 N HCl

900 10, 15, 30 and 45 10/30/2009

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% PolyoxyethyleneLauryl Ether

1000 10, 20, 30 and 45 05/31/2007

Lenalidomide Capsule II (Paddle) 50 0.01 N HCl 900 10, 15, 20, 30 and45

04/15/2008

Letrozole Tablet Refer to USP 04/10/2008 Leucovorin Calcium Tablet Refer to USP 07/14/2008 Leuprolide Acetate Injectable (Extended

Release) Develop a dissolution

method using USP IV(Flow-Through Cell),and, if applicable,Apparatus II (Paddle) orany other appropriatemethod, for comparativeevaluation by theAgency

01/15/2010

Levetiracetam Tablet II (Paddle) 50 Water (deaerated) 900 5, 10, 15 and 30 02/05/2004 Levetiracetam Tablet (Extended

Release) I (Basket) 100 0.05 M Phosphate

Buffer, pH 6.0 900 1, 2, 4, 6, 8 and 12

hours 04/02/2009

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 (Apparatus5)

50 Acetic acid/sodiumacetate buffer, pH 4.0 at32C

500 10, 20, 30, 60, 120and 180

01/03/2007

Linagliptin Tablet I (Basket) 50 0.1 N HCl 900 5, 10, 15, 20, 30and 45

08/15/2013

Linezolid Tablet II (Paddle) 50 0.05 M PhosphateBuffer, pH 6.8

900 5, 10, 20, 30 and45

01/14/2008

Linezolid Suspension II (Paddle) 50 0.05 M PhosphateBuffer, 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


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 Lomustine Capsule Develop a dissolution

method

Lopinavir/Ritonavir Tablet (Combination) II (Paddle) 75 0.06 M Polyoxyethylene10 Lauryl Ether

900 15, 30, 60, 90, and120

09/13/2007

Lopinavir/Ritonavir Capsule (Soft-Gelatin) II (Paddle) 50 Tier 1: 0.05 MPolyoxyethylene 10Lauryl Ether with 10 mMSodium Phosphatemonobasic (pH 6.8); TierII: same as above withNMT 1750 USP units/Lof Pancreatin

900 10, 15, 30 and 45 06/18/2007

Loratadine Tablet (Chewable) II (paddle) 50 0.1 N HCl 500 15, 30, 45 and 60 07/14/2008 Loratadine Tablet (Orally

Disintegrating) I (Basket) 50 SGF without enzyme 900 2, 4, 6 and 10 07/14/2008

Loratadine Capsule (Soft-Gelatin) II (Paddle) withsinker

75 Tier I: 0.1N HCl with0.1% Tween 20. Tier II:0.1N HCl with 0.1%Tween 20 with additionof pepsin (as per USP).

900 10, 20, 30, 45 and60

02/28/2013

Loratadine/Pseudoephedrine Sulfate (10mg /240 mg)


I (Basket) 75 900 mL 0.1 N HCl forone hour, then replacethe medium with 900 mL0.05 M phosphate bufferat pH6.8 containing0.01% sodium laurylsulfate.

900 Loratadine:10, 15,20, 30 and 45;Pseudoephedrine:1, 2, 4, 8, 12, 16, 18and 24 hours

08/05/2010



Loratadine/Pseudoephedrine Sulfate (5 mg/120 mg)


II (Paddle) 50 900 mL 0.1 N HCl forone hour, then replacewith 900 mL 0.05 Mphosphate buffer at pH8.2 containing 0.01%sodium lauryl sulfate

900 Loratadine:15, 20,30, 45, 60 and 90;Pseudoephedrine:1, 2, 4, 8, 12 and 16hours

08/05/2010

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 Losartan Potassium Tablet Refer to USP 01/05/2012 Loteprednol Etabonate/Tobramycin Ophthalmic



01/31/2013

Lovastatin/Niacin Tablet (ExtendedRelease)

I (Basket) 100 For Niacin: Water; forLovastatin: 0.05 Mphosphate buffer, pH 7.0with 0.5% sodiumdodecyl sulfate

900 For Niacin: 0.5, 1,2, 3, 6, 9, 12, 20and 24 hours; ForLovastatin: 15, 30,45 and 60 min

01/14/2008

Lubiprostone Capsule (Soft-Gelatin) II (Paddle) 50 0.1 N HCl/1% HCO-40(Polyoxyl 40hydrogenated castoroil)

900 15, 30, 45, 60, 90and 120

08/19/2010

Lurasidone HCl Tablet II (Paddle) 50 McIlvaine buffer, pH 3.8[(0.0.025 M Citric acidSolution + 0.05MNa2HPO4 solution(3:2)] Measure the pHand adjust to 3.8, ifnecessary. Degasbefore use.

900 5, 10, 15, 20 and30

01/31/2013

MagnesiumHydroxide/Omeprazole/SodiumBicarbonate

Tablet (Chewable) II (Paddle) 150 pH 7.4 Phosphate Bufferwith 0.5% SDS

900 15, 30, 45, 60 and90

10/06/2008

MagnesiumHydroxide/Omeprazole/SodiumBicarbonate

Tablet (Chewable) II (Paddle) 150 0.029 M sodiumphosphate buffer w/0.5% SDS, pH 7.4

900 15, 30, 45, and 60 02/19/2008

Maraviroc Tablet I (Basket) 100 0.01 N HCl 900 10, 15, 20, 30 and45

10/21/2010

Mebendazole Tablet (Chewable) II (Paddle) 75 0.1 N HCl containing 1%Sodium Lauryl Sulfate

900 15, 30, 45, 60, 90and 120

10/06/2008

Meclizine HCl Tablet (Chewable) I (Basket) 100 0.01 N HCl 900 10, 20, 30, 45 and60

04/08/2010

Meclizine HCl Tablet I (Basket) 100 0.01 N HCl 900 10, 20, 30, 45 and60

08/27/2009

Medroxyprogesterone Acetate Injectable Suspension Test 1: IV (Flowthrough cell),22.6 mm cell,13 g of 1 mmbeads; Test 2: II(Paddle)

Test 1: 17 mL/min;Test 2: 50 rpm

Test 1: 0.5 % SDS inwater ; Test 2: 0.35 %SDS in water (providedata with both tests)

Test 1:use OpenMode: Test 2: 900mL

Test 1: 5, 10, 15,20, 30, 40, 50, 60,70, 80 and 90; Test2: 5, 10, 15, 30, 60,90, 120, 240, 360,1440 and 2880

10/31/2013

Mefenamic Acid Capsule Refer to USP 12/15/2009 Mefloquine HCl Tablet I (Basket) 100 SGF without enzyme 900 10, 20, 30, 45 and

60 02/06/2004

Megestrol Acetate Oral Suspension Refer to USP 12/15/2009 Meloxicam Tablet II (Paddle) 75 Phosphate Buffer, pH

7.5 900 10, 20, 30, 45 and

60 02/20/2004

Meloxicam Suspension II (Paddle) 25 Phosphate buffer at pH7.5

900 5, 10, 15 and 30 01/26/2006

Melphalan Tablet Refer to USP 07/14/2008 Memantine HCl Capsule (Extended

Release) I (Basket) 100 pH 1.2 Buffer, Simulated

Gastric Fluid withoutenzyme

900 1, 2, 4, 6, 8, 10, 12and 16 hours

10/28/2010

Memantine HCl Tablet I (Basket) 100 0.1 N HCl with NaCl (12g NaCl in 6 L wateradjust pH to 1.2 withHCl)

900 10, 20, 30 and 45 12/16/2005

Menthol/Methyl Salicylate Topical Patch VI (Cylinder) 50 Neutralized phthalatebuffered solution (0.2 Mpotassium biphthalate)with pH of 5.0 at 32 0.5C

900 10, 20, 30, 60, 120,150 and 180

01/31/2013

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 Suppository II (Paddle) withoption to use asinker

75 (for 500 mg) &125 (for 1000 mg)

For 500 mg strength:0.2 M Phosphate buffer,pH 7.5 at 37 deg. C For1000 mg strength: 0.2 MPhosphate buffer, pH7.5 at 40 deg. C

900 30, 60, 90, 120 and150

01/30/2006

Mesalamine (1.2 gram) Tablet (DelayedRelease)

II (Paddle) 100 Acid stage (A): 100 mMHCl Buffer stage (B):Phosphate Buffer, pH6.4 Buffer stage (C):Phosphate Buffer, pH7.2

Acid stage (A): 750mL; Buffer stage(B): 950 mL; Bufferstage (C): 960 mL

Acid stage (A): 2hours; Buffer stage(B): 1 hour; Bufferstage (C): 1, 2, 4, 6and 8 hours

06/10/2009

Mesalamine (250 mg and 500 mg) Capsule (ExtendedRelease)


Mesalamine (375 mg) Capsule (ExtendedRelease)

I (Basket) 100 Acid Stage: 0.1N HClBuffer stage: PhosphateBuffer, pH 6.8

Acid stage: 750 mL;Buffer stage: 1000mL

Acid stage: 2 hours;Buffer stage: 0.5, 1,2, 4, 7 and 9 hours

06/10/2009



Mesalamine (400 mg and 800 mg) Tablet (DelayedRelease)


Mesalamine Enema Rectal Enema II (Paddle) 50 Phosphate Buffer, pH7.2

900 5, 10, 15, and 30 06/18/2007

Mesna Tablet II (Paddle) 50 0.06 N HCl 500 5, 10, 15, 20 and30

02/09/2004

Mestranol/Norethindrone Tablet Refer to USP 03/25/2010 Metaxalone Tablet II (Paddle) 100 0.5% SLS in water 900 30, 60, 90 and 120 02/06/2004 Metformin HCl Tablet Refer to USP 04/10/2008 Metformin HCl Tablet (Extended


Metformin HCl/Pioglitazone HCl Tablet II (Paddle) 50 pH 2.5 McIlvaine buffer(0.1 M Citric acidadjusted to pH 2.5 with0.2 M Na2HPO4)

900 10, 20, 30 and 45 01/03/2007

Metformin HCl/Saxagliptin Tablet (ExtendedRelease)

I (Basket) 100 Phosphate Buffer, pH6.8

1000 Metformin: 1, 2, 3,4, 6, 8, 10 and 12hours. Saxagliptin:5, 10, 15, 20 and 30minutes

01/26/2012

Metformin HCl/Sitagliptin Phosphate Tablet II (Paddle) 75 0.025 M NaCl 900 10, 15, 20 and 30 10/06/2008 Metformin/Repaglinide Tablet II (Paddle) 50 Citric acid/phosphate

buffer, pH 5.0 900 5, 10, 15, 20 and

30 10/30/2009

Methadone HCl Tablet Refer to USP 07/14/2008 Methenamine Hippurate Tablet Refer to USP 07/31/2013 Methimazole Tablet Refer to USP 01/14/2008 Methocarbamol Tablet Refer to USP 08/15/2013 Methotrexate Sodium Tablet Refer to USP 04/02/2009 Methoxsalen Capsule Refer to USP 03/25/2010 Methylphenidate Capsule (Extended

Release) II (Paddle) 50 Water 500 1, 2, 4, 6, 8, 12

hours and until atleast 80% released

04/15/2008

Methylphenidate Tablet (ExtendedRelease)

VII(Reciprocatingholder) with oralextendedrelease tabletholder (springholder)

30 cycles per min Water, pH 3.0 250 1, 2, 4, 6, 8 and 10hours

04/15/2008

Methylphenidate Transdermal Patch VI (Cylinder) 50 0.01 N HCl at 32C 900 0.5, 1.5, 3, 4 hoursand until at least80% released

04/15/2008

Methylphenidate (BX) Capsule (ExtendedRelease)

I (Basket) 75 0-2 hrs:0.01 N HCl. 2-10hrs: Phosphate Buffer,pH 6.8.

0-2 hrs: 500. 2-10hrs:500

0.5, 1, 3, 6, 8 and10 hours

07/25/2007

Methylphenidate HCl Tablet (Chewable) I (Basket) 100 Water 900 15, 30, 45 and 60 03/25/2010 Methylphenidate HCl Tablet Refer to USP 07/14/2008 Methylprednisolone Tablet Refer to USP 01/29/2010 Methylprednisolone Acetate Injectable Suspension IV (Flow-

Through Cell-Open system)

0.55 % SDS 15, 30, 45, 60, 90and 120

10/08/2009

Methyltestosterone Capsule Refer to USP 07/31/2013 Methyltestosterone Tablet II (Paddle) 50 Water 900 10, 20, 30, 45, 60

and 75 07/31/2013

Metoclopramide HCl Tablet Refer to USP 07/15/2009 Metoclopramide HCl Tablet (Orally

Disintegrating) I (Basket) 50 Water 900 5, 10, 15, 20, 30

and 45 04/08/2010

Metolazone Tablet II (Paddle) 75 2% SLS in 0.05 MSodium PhosphateBuffer, pH 7.5

900 30, 60, 90, 120 and150

02/10/2004

Metoprolol Succinate Tablet (ExtendedRelease)


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 Metronidazole Tablet Refer to USP 08/05/2010 Miconazole Tablet (Buccal) I (Basket) 60 0.5% SDS (Sodium

dodecylsulfate) in water-pH adjusted to 6.5 0.5

1000 1, 2, 4, 6, 8, 10 and12 hours

10/28/2010

Miconazole Nitrate Suppository (Vaginal) I (Basket) 100 0.45% SLS in water 900 15, 30, 45 and 60 10/08/2009 Midodrine HCl Tablet II (Paddle) 50 0.1 N HCl 900 5, 10, 15 and 30 02/06/2004 Mifepristone Tablet II (Paddle) 75 0.01 N HCl 900 5, 10, 15, 20 and

30 01/14/2008

Miglitol Tablet II (Paddle) 75 Water 900 10, 20, 30, and 45 03/03/2011 Miglustat Capsule I (Basket) 100 0.1 N HCl 1000 10, 20, 30 and 45 01/03/2007 Milnacipran HCl Tablet II (Paddle) 50 0.1 N HCl 900 10, 15, 30, 45 and

60 08/05/2010

Minocycline HCl ER Tablets I (Basket) 100 0.1 N HCl 900 1, 2, 4, 6 hours anduntil 80% of drugreleased

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 Mirabegron Tablet (Extended

Release) I (Basket) 100 Phosphate Buffer, pH

6.8 900 1, 3, 5, 7, 8.5, 10

and 12 hours 05/09/2013

Mirtazapine Tablet II (Paddle) 50 0.1 N HCl 900 5, 10, 15 and 30 02/10/2004 Mirtazapine Tablet (Orally

Disintegrating (ODT)) II (Paddle) 50 0.1 N HCl 900 5, 10, 15, 20 and

30 03/04/2006

Misoprostol Tablet II (Paddle) 50 Water (deaerated) 500 5, 10, 20 and 30 02/10/2004 Mitotane Tablet Refer to USP 06/10/2009 Modafinil Tablet II (Paddle) 50 0.1 N HCl 900 10, 20, 30, 45 and

60 02/10/2004



Moexipril HCl Tablet II (Paddle) 50 Water (deaerated) 900 5, 10, 15 and 30 02/10/2004 Molindone HCl Tablet Refer to USP 07/25/2007

Montelukast Granule I (Basket) (100mesh)

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


Morphine Sulfate Tablet II (Paddle) 50 Deionized Water 900 5, 15, 20 and 30 01/15/2010 Morphine Sulfate (AB) Tablet (Extended

Release) I (Basket) 50 Water (deaerated) 900 1, 2, 3, 6, 9 and 12

hours 12/23/2010

Morphine Sulfate (BC) Tablet (ExtendedRelease)

I (Basket) 100 Water 500 1, 2, 4, 6, 8, 10 and12 hours

12/23/2010

Morphine Sulfate/Naltrexone HCl Capsule (ExtendedRelease)

II (Paddle) 50 Acid stage: 0.1 N HCl;Buffer stage: 0.05Phosphate Buffer, pH7.5


Morphine Sulfate:Acid stage: 1 hour;Buffer stage: 1, 3, 5,8 and 10 hours.Naltrexone HCl:Acid stage: 1 hour;Buffer stage: 1, 12,24, 48, 73 and 96hours.

01/26/2012

Moxifloxacin Tablet II (Paddle) 50 0.1 N HCl 900 15, 30, 45 and 60 06/18/2007 Mycophenolate Mofetil Suspension II (Paddle) 40 0.1 N HCl 900 5, 10, 20 and 30 02/10/2004 Mycophenolate Mofetil Capsule II (Paddle) 40 0.1 N HCl 900 5, 10, 20 and 30 02/10/2004 Mycophenolate Mofetil Tablet II (Paddle) 50 0.1 N HCl 900 5, 10, 15 and 30 02/10/2004 Mycophenolic acid Tablet (Delayed

Release) II (Paddle) 50 Acid Stage: 0.1 N HCl;

Buffer Stage: BufferSolution, pH 6.8 (Afterinitial 120 mins., 250 mLof 0.2 M sodiumphosphate solution isadded to acid stagemedium. The pH of themixture is adjusted to6.8 using 0.2 M sodiumphosphate, 2 N sodiumhydroxide, orconcentrated HCl acidsolution if necessary.)

750 (Acid), 1000(Buffer)

120 (Acid), 10, 20,30, 45 and 60(Buffer)

12/19/2008

Nabilone Capsule II (Paddle) 50 0.1% Tween 80 solution 1000 15, 30, 45 and 60 07/14/2008 Nabumetone Tablet Refer to USP 07/25/2007 Nadolol Tablet Refer to USP 04/02/2009 Naltrexone Injectable Suspension Phosphate buffered

saline with 0.02%Tween 20 and 0.02%Sodium azide, pH 7.4(final osmolality shouldbe 270 20 mOsm), orany other appropriatemedium, at 37C.Develop an in vitrorelease method usingUSP IV (Flow-ThroughCell), and, if applicable,Apparatus II (Paddle) orany other appropriatemethod, for comparativeevaluation by theAgency

09/01/2011

Naltrexone HCl Tablet Refer to USP 04/15/2008 Naproxen Tablet (Delayed


Naproxen Tablet Refer to USP 07/25/2007 Naproxen Sodium Tablet (Extended


7.5 900 0.5, 1, 2, 3, 4, 6, 8,

10, 12 and 14hours

04/08/2010

Naproxen Sodium T

Dissolution Methods FDA

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