Accurate Determination of Mutagenic Azido, NDSRI, and Nitrosamine Impurities in Drug Substances and Products Using LC–MS/MS

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Event Abstract:

Several sartan, ranitidine, and metformin-based drug products have been recalled due to nitrosamine contamination, in unacceptable amounts, in these drugs. Since then, there has been increased scrutiny by the regulators to accurately identify and quantify mutagenic impurities in drug substances and products. The US FDA and other regulatory agencies have published analytical testing guidance documents regarding the evaluation of mutagenic nitrosamine impurities in these drug substances and drug products. Recently, sartan therapeutics were again recalled due to another known mutagenic impurity called azido biphenyl tetrazole (AZBT) impurity. Additionally, there have been recalls related to nitroso impurity in varenicline drug products.

This presentation will address the accurate determination of mutagenic azido impurities, nitroso drug substance related impurities (NDSRIs) and nitrosamine impurities in drug substances and products using liquid chromagraphy–tandem mass spectrometry (LC–MS/MS) based analytical strategies that you can adopt to meet your nitrosamine detection and quantitation needs.

Key Learning Objectives:

• Understand what mutagenic impurities are and the importance of characterizing and quantifying them
• Learn about approaches for the confident identification and quantification of nitroso drug substance related impurities (NDSRIs) and nitrosamine impurities in APIs and drugs
• Learn about approaches for the confident identification and quantification of azido impurities in five different sartan therapeutics
  

Who Should Attend:

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

Speakers

Kartheek Srinivas Chidella
Application Engineer
Agilent Technologies

Kartheek Srinivas Chidella has more than 13 years of experience in the pharmaceutical and analytical industry working on LC–MS/MS. After completing his M.Sc. (Organic Chemistry) at Andhra University, Kartheek started his career at Dr. Reddys Laboratories in Analytical & Bioanalytical department and developed several LC–MS/MS methods for determination in drugs in biological matrices. He later joined Mylan Laboratories in analytical development and worked on impurity profiling applications using LC–MS/MS. He later joined Waters as an LC–MS technical and application support specialist and now in his current role as application engineer in Agilent, he is actively involved in providing application support for genotoxic impurity applications using LC–MS/MS.

Register Free: https://www.chromatographyonline.com/lcgc_w/azido