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ePT--the Electronic Newsletter of Pharmaceutical Technology
The US Pharmacopeial (USP) Convention has announced new standards for heparin and glycerin.
Rockville, MD (Feb. 4)-The US Pharmacopeial (USP) Convention has announced new standards for heparin and glycerin. USP revised the heparin standard at the request of the US Food and Drug Administration, in response to adulterated heparin product with over-sulfated chondroitin, which resulted in the deaths of 200 people. Glycerin, a sweetener and binding agent, has been adulterated in the past by dilution with diethylene glycol. The new standards for glycerin becomes official in May 2009, and the new standards for heparin becomes official in August 2009 after a public comment period. All manufacturers of these products are required to comply with the standards.
The US Food and Drug Administration requested a new glycerin standard that establishes limits for diethylene glycol and revises other “high risk” articles that have similar applications. FDA also requested a revised heparin monograph to detect the presence of over-sulfated chondroitin sulfate. In addition, the modernized heparin monograph aims to provide improved analytical methods, improved measurement of heparin activity, and the development of associated reference standards (i.e., heparin identity, heparin potency, oversulfated chondroitin sulfate, and dermatan sulfate).
“These new USP quality standards provide better assurance of the quality of marketed products by using appropriate and modern analytical methods,” says Moheb Nasr, PhD, director of the Office of New Drug Quality Assessment (ONDQA), at FDA's Center for Drug Evaluation and Research (CDER), in a USP press release. “This provides a considerable safeguard for citizens of the United States and the world by helping to prevent fraudulent suppliers from adding components that in the past have eluded existing identity tests due to similar properties. The new standards represent a significant improvement to the safety nets that keep substandard drugs from reaching the marketplace. FDA is pleased to have worked together with USP on this effort.”