Expert interview: Are nitrosamine formation inhibitors the key to successful mitigation plans?

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The presence of toxic nitrosamine impurities in drug substances and drug products has become a significant focus for the pharmaceutical industry following their identification above permitted limits in common drug products prescribed for type 2 diabetes, high blood pressure and heartburn. To learn more about the situation, we interviewed David Elder – CMC consultant – who explained what we know about nitrosamine impurities, how they form, and the steps formulators can take to minimize the risk of formation in existing drug products and future developments.

Elder has 45 years of service within the pharmaceutical industry, with Sterling, Syntex and 23 years with GSK. He is now an independent CMC consultant and has broad based experience in impurity control, formulation (including stabilization strategies) and analytical method development.

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