Accurate determination of mutagenic azido, NDSRI and nitrosamine impurities in drug substances and products using LC-MS/MS

DATE

February 17, 2022

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FIRST SESSION

6:00 a.m. PST, 9:00 a.m. EST, 14:00 GMT, 15:00 CET

Duration: 60 Minutes

SECOND SESSION

11:00 a.m. PST, 2:00 p.m. EST, 19:00 GMT, 20:00 CET

Duration: 60 Minutes

Overview

Several sartan, ranitidine and metformin-based drug products were recalled due to unacceptable levels of nitrosamine contamination. Since then, pharmaceutical companies have been under increased scrutiny by regulators to accurately identify and quantify mutagenic impurities in drug substances and products. The USFDA and other regulatory agencies have published analytical testing guidances to evaluate mutagenic nitrosamine impurities in these drug substances and drug products. Recently, sartan therapeutics were again recalled due to another known mutagenic impurity, Azido Biphenyl Tetrazole (AZBT), by various regulatory agencies. Additionally, there were recalls related to nitroso impurity in Varenicline drug products.

In this presentation, we will discuss a sensitive and effective method for the accurate determination of mutagenic azido impurities, NDSRI (Nitroso Drug Substance Related Impurity) and nitrosamine impurities in drug substances and products using LC-MS/MS based analytical strategies that you can adopt to meet your nitrosamine detection and quantitation requirements.

Key Learning Objectives:

Understand what mutagenic impurities are and the importance of characterizing and quantifying them.
Learn approaches for confident identification and quantification of NDSRI (Nitroso Drug Substance Related Impurity) and nitrosamine impurities in APIs and drugs
Learn proven methods for 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 managers

Brought to you by:

Speakers

Kartheek Srinivas Chidella
Application Engineer,
Agilent Technologies

Catherine Dold
Health & Environment Writer,
C&EN Media Group

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February 17, 2022, 9:00am ET

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