LC/MS methods for the accurate determination of nitrosamines produced in the manufacture of APIs and drugs

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.

WHAT WILL YOU LEARN

• 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

WHO SHOULD ATTEND

• Laboratory managers
• Chromatographers
• Analytical chemists and scientists
• New product developers

Presenter: Chander Mani (Application Engineer, Agilent Technologies)