Nitrosamine Impurities in Excipients

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Just in case you did not capture, I just published a new application note in the Analytical Hub for testing nitrites in Crospovidone…

Quantification of nitrite and nitrate in Crospovidone by ion chromatography

This application note was created to aid in risk assessment and the development of control strategies for evaluating nitrite levels in excipients. It also serves as an analytical resource for regulators and the pharmaceutical industry to determine nitrite and nitrate levels in excipients and to study lot-to-lot variability This analytical note describes a selective and sensitive ion chromatography procedure for determining nitrite and nitrate levels in Crospovidone. The analytical procedure uti…