FDA Drug Dissolution Methods

$179 / year

For a drug product that does not have a dissolution test method in the United States Pharmacopeia (USP), the Food and Drug Administration (FDA) Dissolution Methods Database provides information on dissolution methods presently recommended by the Division of Bioequivalence, Office of Generic Drugs.

Complexity

The Food and Drug Administration (FDA) is providing the Dissolution Methods Database to aid industry personnel in developing generic drug products.
All drug products are listed alphabetically by non-proprietary (generic) names. For combination products, the active drug components appear in alphabetical order of their chemical generic names.
For most of the drugs in the database, the preparation of the recommended dissolution medium is described in the United States Pharmacopeia (USP). Under normal circumstances, the dissolution testing should be conducted at 37° C unless otherwise noted.

Date Created

2015-03

Last Modified

2020-07-02

Version

2020-07-02

Update Frequency

Quarterly

Temporal Coverage

N/A

Spatial Coverage

United States

Source

John Snow Labs; U.S. Food and Drug Administration (FDA);

Source License URL

Source License Requirements

N/A

Source Citation

N/A

Keywords

Dissolution Methods, Dissolution Test Method, FDA Drug Products, United States Pharmacopeia, Generic Drug Products, Chemical Generic Names, Drugs Database

Other Titles

FDA Dissolution Methods Database, FDA Recommended Dissolution Methods Database

NameDescriptionTypeConstraints
Drug_NameDrug non-proprietary namestringrequired : 1
Dosage_FormDosage Form of the drugstringrequired : 1
USP_ApparatusRelated USP Apparatus, A description of each official apparatus appears in the United States Pharmacopeia (USP)string-
Speed_RPMsSpeed in RPMsstring-
MediumDissolution medium of USPstringrequired : 1
Volume_mlVolume in mlstring-
Recommended_Sampling_Times_MinutesTimes recommended for taking dissolution samples for a particular drug product to generate a dissolution profilestring-
Date_UpdatedLast Update Datedate-
Drug NameDosage FormUSP ApparatusSpeed RPMsMediumVolume mlRecommended Sampling Times MinutesDate Updated
Abacavir SulfateTabletRefer to FDA's Dissolution Guidance, 20182020-07-02
Abacavir Sulfate/Dolutegravir Sodium/LamivudineTabletII (Paddle)85.00.01 M Phosphate Buffer with 0.5% sodium dodecyl sulfate (SDS), pH 6.8900Abacavir and lamivudine: 10, 15, 20, 30 and 45; Dolutegravir: 5,15, 25, 35 and 45.2015-05-28
Abacavir Sulfate/LamivudineTabletII (Paddle)75.00.1 N HCl90010, 20, 30, and 45 2007-01-03
Abacavir Sulfate/Lamivudine/ZidovudineTabletII (Paddle)75.00.1 N HClAcid Stage: 900 mL; Buffer Stage: 1000 mL5, 10, 15, 30 and 452007-01-03
AbemaciclibTabletII (Paddle)75.00.01 N HCl9005, 10, 15, 20 and 302017-11-16
Abiraterone AcetateTabletII (Paddle)50.00.25% SLS in 56.5 mM phosphate buffer, pH 4.590010, 20, 30, 45 and 60 2013-02-28
AcalabrutinibCapsuleRefer to FDA's Dissolution Guidance, 20182020-07-02
Acamprosate CalciumTablet (Delayed Release)I (Basket)180.0Acid Stage: 0.1 N HCl Buffer Stage: "Citrate-sodium hydroxide" buffer pH 6.8 (150 ml of 2N NaOH, 21.014 gm of citric acid and ultra-pure water to 1000 ml) (Method B)Media 1: 750 mL pH 1.1±0.1; Media 2: 950 mL pH 6.0±0.1; Media 3: 1000 mL pH 7.5±0.1120 (Acid) 30, 60, 90, 120, and 180 (buffer)2005-12-20
AcarboseTabletII (Paddle)75.0Water (deaerated)90010, 15, 20, 30 and 452006-03-22
AcarboseTabletRefer to FDA's Dissolution Guidance, 20182020-07-02