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Santosh Bhende

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Review Open access Oct 2026

Risk-Based Determination of Analytical Sensitivity (LOQ) for Nitrosamine Impurities Using Acceptable Intake Limits

N-nitrosamine impurities found in the global pharmaceutical supply chain have forced an urgent transformation in the development of risk-based analytical monitoring and advanced quality control standards. The pivotal 2018 finding of the compound N-nitrosodimethylamine in the "sartan" drug class prompted the transition...

Santosh Bhende, A. Phatak, P. Chaudhari · 0 citations

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