Cole and Jaenisch dig into AI poisoning in pharma manufacturing, how it hides in plain sight, and who should be accountable for catching it.
News|Articles|December 5, 2025
Executive Summary: Mastering Nitrosamines Analysis With Streamlined LC-MS/MS Solutions
Author(s)SCIEX
Nitrosamine contamination in pharmaceuticals has become a major regulatory concern due to their potent carcinogenicity, requiring ultra-trace-level detection to ensure patient safety. Advanced LC-MS/MS workflows provide the necessary sensitivity, selectivity, and robustness to accurately quantify nitrosamine drug substance-related impurities (NDSRIs), even within complex pharmaceutical matrices. Case studies with betahistine, orphenadrine, and chloropyramine demonstrate how streamlined LC-MS/MS strategies can reliably detect and confirm nitrosamine impurities well below regulatory thresholds.
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