FDA Drug Dissolution Methods

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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

2018-03-27

Version

2018-03-27

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

John Snow Labs Standard License

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

Name Description Type Constraints
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
DapsoneTabletRefer to USP2010-12-23
DigoxinTabletRefer to USP2007-06-18
NadololTabletRefer to USP2009-04-02
AspirinCapsuleRefer to USP2015-05-28
AtenololTabletRefer to USP2014-02-14
BaclofenTabletRefer to USP2009-12-15
CefiximeTabletRefer to USP2010-12-23
DanazolCapsuleRefer to USP2007-06-18
DiazepamTabletRefer to USP2007-07-25
EtodolacTabletRefer to USP2008-01-14