Heparin Adulteration Triggered Pharmaceutical Identity Crisis
This article was originally published in The Gold Sheet
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.
You may also be interested in...
Manufacturers could risk losing FDA product approvals if they fail to publicize sourcing and quality information, under new proposals. National Academies expert panel says supply chain transparency – not a pandemic-induced rush to onshoring requirements – provides the framework to mitigate against and respond to drug shortages.
The FDA's Francis Godwin tells Pink Sheet of progress battling supply chain obfuscation, which could allow marketing of adulterated drugs; Yino warning letter is latest salvo.
The FDA must explain how it will prevent heparin adulteration as a virus kills pigs in China again.