FDA Dissolution Methods Database

The U.S. Food and Drug Administration has created the FDA Dissolution Methods Database for drug products that do not have a drug product dissolution test method in the United States Pharmacopeia (USP). This database is maintained by the Division of Bioequvivalence, Office of Generic Drugs. With this Database, FDA intends to support industry personnel in developing generic drug products.

You can search for the relevant active drugs with the help of a search tool. Even a combination of two active drugs in one product is possible.

For most of the drugs in the database, the preparation of the recommended dissolution medium is carried out as described in the USP.  Under normal circumstances, the dissolution testing should be conducted at 37° C unless otherwise noted.

FDA generally recommends that by the last sampling point, at least 70-85% (Q) of the labeled content of the active drug should be dissolved.

FDA updates the database quarterly.

The ECA Conference "Dissolution Testing - Development - Quality Control - and in vivo Relevance" taking place from 17-19 October 2012 in Berlin gives a comprehensive overview of the actual requirements on dissolution methods both from an European and an American point of view.

You can receive further information on this database on FDA's FAQ page on dissolution methods.

Here is a complete list of all methods.

Dr. Günter Brendelberger
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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