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Sandesh R. Lodha on Muck Rack

Sandesh R. Lodha

As seen in: Wiley Online Library, Royal Society of Chemistry
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Articles

Assessment of Nitrosamine Impurities in Lurasidone Hydrochloride Using APCI‐LC-MS/MS in MRM Mode for Regulatory Compliance and Stability Evaluation

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By Anant Yadav, Ashish C. Alaspure, Sandesh R. Lodha, Pinal S. Bhavsar
| Wiley Online Library Verified
Anant D. Yadav Tarsadia Institute of Chemical Science, Uka Tarsadia University, Bardoli, Gujarat, India Analytical Research and Development, Alkem Laboratories Ltd., Bharuch, Gujarat, India Contribution: Writing - review & editing, Conceptualization, Validation, Writing - original draft, Visualization, Formal analysis, Methodology, Resources Search for more papers by this author
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Ultrasensitive LC-MS/MS Quantitation of N-Nitroso-Dabigatran Etexilate Impurity in Dabigatran Etexilate Mesylate Using Electrospray Ionization Technique.

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By Anant Yadav, Ashish C. Alaspure, Sandesh R. Lodha, Amrutlal Prajapat
| Royal Society of Chemistry Verified
Ultrasensitive LC-MS/MS Quantitation of N-Nitroso-Dabigatran Etexilate Impurity in Dabigatran Etexilate Mesylate Using Electrospray Ionization Technique. Nitrosamine impurities, particularly nitrosamine drug substance-related impurities (NDSRIs), pose significant health risks due to their potential mutagenicity and carcinogenicity. Consequently, stringent regulatory guidelines have been established for their detection and quantification in pharmaceutical products.
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