Module 3 Presentations

14/05/2024

Impurities in APIs - Heparin  2008 Heparin Contamination lead to serious injuries (785) and deaths in USA (at least 81)  Chinese DS source sold by Scientific Protein Labs to Baxter USA intentionally contaminated with much cheaper over-sulphated chondroitin sulphate o Shortage of pigs for heparin production o Mimics heparin in vitro properties so was hard to see with monograph tests of the day o Only identified by chromatography after the event

27

27

Heparin -2

 Illustrates need for MA holder to fully control API source (ICH Q7)  Manufacturers recalled many products containing heparin from China (gave anaphylactoid reactions)  Modified USP and Ph Eur monographs to add specific NMR and electrophoresis testing to control this impurity

28

28