Heparin Adulteration Triggered Pharmaceutical Identity Crisis

Executive Summary

Pharmaceutical identity crisis arises after ingredients are mimicked by cheap, deadly substitutes. Chemical sleuths tell how they found the melamine cyanurate, oversulfated chondroitin sulfate and diethylene glycol that were hidden in pet food, heparin and cold remedies. Efforts to better identify drug ingredients takes on new urgency with melamine spreading to infant formula and rumors of possible attempts to devise a new heparin adulterant. As instrumental compendial tests are added to monographs, industry, legislators, regulators and compendial organizations grapple with broader implications of this new type of adulteration. U.S. Pharmacopeia leadership talks about establishing a massive standardized spectral library that could be accessed using remote analyzers to instantly identify ingredients, impurities and adulterants.