USP to Help Develop New Heparin Contaminant Testing

April 22, 2008
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

The United States Pharmacopeial Convention (USP) has agreed to work with the US Food and Drug Administration on developing more sensitive tests for detecting contaminants such as over-sulfated chondroitin, which was found in batches of heparin last January.

Rockville, MD (Apr. 14)-The United States Pharmacopeial Convention (USP) has agreed to work with the US Food and Drug Administration on developing more sensitive tests for detecting contaminants such as over-sulfated chondroitin, which was found in batches of heparin last January. The contaminant has shown to “mimic” the blood-thinning properties of the drug and quality tests at that time were unable to detect it.

According to a prepared statement, FDA asked USP in March for help in “reassessing current tests and possibly developing new methods for detecting over-sulfated chondroitin in the heparin drug substance before it is made into final product.” The objective of this work is to develop an updated heparin monograph.

According to Roger L. Williams, MD, USP’s chief executive officer, “It is difficult for analytical procedures to detect and identify all adulterants. USP monographs are designed to test for known impurities that result from manufacture or degradation, not for unknown contaminants that may be added either accidentally or deliberately. USP will continue to work closely with FDA and other partners to develop the most effective approaches to assure the safety of heparin.”