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Ramesh Kola

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2 papers indexed here

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Open access Oct 2026

Highly Sensitive LC–QTOF‐MS Method Development and Validation for Trace Level Determination of N ‐Nitroso Tizanidine in Tizanidine Drug Substance and Formulations

Nitrosamine drug substance–related impurities have been a central focus of regulatory scrutiny due to their potential mutagenic and carcinogenic effects. Among these, N ‐nitroso tizanidine ( N ‐NTZD) is a possible impurity that may form during the manufacturing, processing, or storage of tizanidine (TZD) drug s...

Mallikarjun Koganti, Ramesh Kola, Haritha Reddy Nagidi · 0 citations
Aug 2026

Development and Validation of a Highly Sensitive Liquid Chromatography–Tandem Mass Spectrometry Method for the Quantitative Determination of Mutagenic N‐ Nitroso Mefenamic Acid in Pharmaceutical Formulations

A highly sensitive liquid chromatography–tandem mass spectrometry method was developed and validated for trace‐level quantification of this impurity in MAA formulations, ensuring reliable detection and control of mutagenic impurities in MAA formulations.

G. P. Kumar, Ramesh Kola, Ramarao Abburi · 0 citations

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