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Author

P. Chaudhari

2 papers indexed here

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Review Sep 2026

Nitrite-Driven Nitrosamine Formation in Pharmaceutical Systems: A Water-Mediated Risk Framework and Control Strategies

N-nitrosamines are genotoxic impurities whose detection in several marketed medicines has raised major safety concerns for pharmaceutical systems. They form when nitrosating agents - particularly nitrite - react with amine precursors under favourable physicochemical conditions. This review examines nitrite-driven nitro...

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