PharmTech AI Pulse Check episode 2 covers AI data governance, API-gated journals, watermarking limits, and why attribution beats detection in GxP.
|Articles|April 17, 2023
Determination of Eight Nitrosamine Impurities
Author(s)Agilent
This application note demonstrates that the Agilent 6475 triple quadrupole LC/MS system can confidently quantify nitrosamine impurities at the low concentration levels specified by regulatory requirements. This method can be used to quantify these impurities in different ARB drug products, with some changes in chromatographic conditions based on the elution pattern of the drug product.
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