Pharmaceutical companies are coming under increased scrutiny by regulators across the world to accurately identify and quantify mutagenic impurities in drug substances and products. Recently, several sartan and ranitidine-based drug products were recalled due to the presence of nitrosamine contaminant in unacceptable amounts in these drugs. Consequently, the USFDA published analytical testing methods to provide guidance to regulators and industry to evaluate mutagenic nitrosamine impurities in sartans and ranitidine drug substances and drug products. In this presentation, we will cover the US FDA regulations for the detection of nitrosamines. We will also review the relevant GC/MS and LC/MS based analytical strategies for the identification and quantification of these nitrosamines in APIs and drugs.
Understand what mutagenic impurities are and why it’s important to characterize and quantify them, even when present in trace amounts.
Understand the current regulatory guidelines for mutagenic impurity analysis in drug substance and product with an emphasis on nitrosamines in Angiotensin II Receptor Blockers (Sartan) and Ranitidine drug
Learn about approaches for the confident identification and quantification of nitrosamines in APIs and drugs