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What is Nitrosamines Testing by GC-MS/MS about?

This document outlines a test procedure for detecting nitrosamines in sartan drug preparations using GC-MS/MS, focusing on specific nitrosamines at a limit of quantification of 15 ppb. It details the extraction method, validation requirements, and necessary equipment and materials, emphasizing the importance of safety due to the carcinogenic nature of nitrosamines. The procedure includes sample preparation, calibration, and evaluation methods to ensure accurate results and compliance with established limits

Author

Rishabh Nagar

Language

EN