Analysis of Nitrosamine Impurities in Pharmaceuticals – Current challenges and future perspectives

Pharmaceutical companies are coming under increased scrutiny by regulators across the world to accurately identify and quantify trace level nitrosamine impurities in drug substances and products. In this presentation, we will cover a brief introduction of N-Nitrosamines, past experiences and current scenarios. We will provide a summary of genotoxic impurities (GTIs), literature, regulations, and expectations of the regulatory bodies. We will also discuss proactive measures to be taken to minimize the formation of GTIs like nitrosamines.

Key Learning Objectives

• 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 nitrosamines analysis in drug substance and product in Angiotensin II Receptor Blockers (sartan), ranitidine and metformin drugs
• Learn about approaches for the prevention of the formation of GTIs and the confident identification and quantification of nitrosamines in APIs and drugs

Who Should Attend

• Laboratory managers
• Chromatographers
• Analytical chemists and scientists
• New product developers
• Pharma manufacturing and quality control managers

Presenter: Raman V.V.S.S. Nanduri, Ph.D. (Director, Analys Lab Pvt. Lt)

Presenter: Kelly McSweeney (Contributing Editor, C&EN Media Group)