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...
One in five drug GMP warning letters FDA issued in 2022 raised supply chain concerns. Active pharmaceutical ingredient distribution became major focal point as agency checked opioid and alcohol-based hand sanitizer supply chains. Year also featured a pair of warning letters to excipient firms, one a Mexican glycerin supplier and the other a unit of DuPont.
One in five of the drug GMP warning letters the US FDA issued in 2022 raised supply chain concerns. Active pharmaceutical ingredient distribution became a major focal point as agency checked opioid and alcohol-based hand sanitizer supply chains. The year also featured a pair of warning letters to excipient firms, one a Mexican glycerin supplier, and the other a unit of DuPont.
After a student analyst was caught fabricating Smithfield heparin data, Miami University chemistry department established a quality system and more than 20 quality procedures in time for an FDA inspection, but to no avail. The warning letter that followed was predicated on failures that had already occurred.