Analysis of Nitrosamine Impurities in Pharmaceuticals

What you will 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 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


Raman V.V.S.S. Nanduri, Ph.D.
Analys Lab Pvt. Lt


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Quality Control | Nitrosamine Mutagenic Impurities

Several drug products were recently recalled due to the presence of unacceptable amounts of mutagenic nitrosamine impurities. Chemetrix offers relevant GC/MS, LC/MS and high-throughput MS-based analytical technologies to accurately detect and quantify trace mutagenic and genotoxic impurities in drug products.



Nitrosamine Impurities Application Guide

Application Guide

Determination of Nitrosamine Impurities Using the Ultivo Triple Quadrupole LC/MS

Application Note

Quantification of Nitrosamine Impurities in Metformin Using Agilent GC/MS/MS Instrumentation

Application Note

Determine Nitrosamines Using LC/MS in Metformin-Based Drugs

Application Note

Determination of a Genotoxic NDMA Impurity Using the High-Resolution Agilent 6546 LC/Q-TOF in Ranitidine

Application Note