Pharmaceutical impurities, specifically mutagenic impurities in APIs and drug products can significantly affect the stability and efficacy of the drug, and impact safety. Recently, several manufactured lots of Angiotensin II Receptor Blockers (Sartan) and Ranitidine drugs have been recalled due to the presence of high potency mutagenic impurities (nitrosamines) found in these products as a result of a manufacturing process change. Pharmaceutical companies are coming under increased scrutiny by regulatory authorities to accurately identify and quantify mutagenic impurities in drug substances and products. Recently, the US FDA published analytical testing methods to provide options for regulators and industry to detect nitrosamine impurities in Sartans and Ranitidine drug substances and products. These methods should be validated by the user if the resulting data are used to support a required quality assessment of the API or drug product, or if the results are used in a regulatory submission.
In this 2-part webinar series, we will review the US FDA regulations and present analytical strategies for the identification and quantification of nitrosamines. In the first webinar, we will review relevant GC/MS analytical methods followed by the second webinar where will present LC/MS based analytical strategies for the identification and quantification of these nitrosamines in APIs and drugs.
