FDA_USP-溶出度方法汇总.doc

Dissolution Methods List of all Drugs in the Database Drug Name Dosage Form USPApparatus Speed (RPMs) Medium Volume (mL) Recommended Sampling Times (minutes) Date Updated Abacavir Sulfate Tablet II (Paddle) 75 0.1 N HCl 900 5, 10, 15, and 30 03/22/2006 Abacavir Sulfate/Lamivudine Tablet II (Paddle) 75 0.1 N HCl 900 10, 20, 30, and 45 01/03/2007 Abacavir Sulfate/Lamivudine/Zidovudine Tablet II (Paddle) 75 0.1 N HCl 900 5, 10, 15, 30, and 45 01/03/2007 Acamprosate Calcium Tablet (Delayed Release) I (Basket) 180 Acid Stage: 0.1 N HCl Buffer Stage: Citrate-sodium hydroxide buffer pH 6.8 (150 ml of 2N NaOH, 21.014 gm of citric acid and ultra-pure water to 1000 ml) (Method B) 1000 120 (Acid) 30, 60, 90, 120, and 180 (buffer) 12/20/2005 Acarbose Tablet II (Paddle) 75 Water (deaerated) 900 10, 15, 20, 30 and 45 03/22/2006 Acetaminophen Suppository II (Paddle) 50 Phosphate buffer, pH 5 900 15, 30, 45, 60 and 90 08/17/2006 Acetaminophen 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 Tablet II (Paddle) 50 Water 900 10, 15, 30, 45, and 60 07/25/2007 Acetaminophen/Caffeine/Dihydrocodeine Bitartrate Capsule I (Basket) 100 Water 900 10, 20, 30, 45 and 60 01/03/2007 Acetaminophen/Hydrocodone Bitartrate Tablet Refer to USP 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/Propoxy