Module 3 2019

Impurities in APIs - Heparin

➢ 2008 Heparin Contamination lead to serious injuries and deaths in USA (at least 81) ➢ Chinese DS source sold by Scientific Protein Labs ➢ Manufacturers recalled many products containing heparin from China contaminated with over-sulphated chondriotin sulphate ➢ Modified USP and Ph Eur monographs to add specific NMR and electrophoresis testing

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