Accurate determination of mutagenic azido, NDSRI and nitrosamine impurities in drug substances and products using LC-MS/MS
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
Presenter: Kartheek Srinivas Chidella (Application Engineer, Agilent Technologies)
Presenter:Catherine Dold (Health & Environment Writer, C&EN Media Group)
