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Author

Trivikram Reddy Gundala

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Sep 2026

A Highly Sensitive Liquid Chromatography–Triple Quadrupole Mass Spectrometric Method for the Simultaneous Trace‐Level Quantification of Trofinetide N‐Nitrosamine Impurities in Trofinetide Drug Substance

Regulatory authorities worldwide mandate stringent monitoring and control of N‐nitrosamine drug substance‐related impurities due to their potential carcinogenic risk, in order to ensure the safety, quality, and efficacy of pharmaceutical products throughout their lifecycle. In this context, the present study invest...

Kishore Gaddam, Surendranath Reddy Reddiwary, Nagavelli Ramu et al. · 0 citations

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