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GC/MS methods for the accurate determination of nitrosamines produced in the manufacture of APIs and drugs
March 11, 2020
First Session: 9:00 a.m. EDT / 6:00 a.m. PDT / 13:00 GMT / 14:00 CET
Repeat Session: 1:00 p.m. EDT / 10:00 a.m. PDT / 17:00 GMT / 18:00 CET
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.
Register now for the second webinar in this series, March 18, 2020:
LC/MS methods for the accurate determination of trace nitrosamines produced in the manufacture of APIs and drugs
Brought to you by:
- 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
- Laboratory managers
- Analytical chemists and scientists
- New product developers
Parul Angrish, PhD
Pharma Marketing Manager,
Soma Dasgupta, PhD
C&EN Media Group