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has been cited by the following article:

• TITLE: Quantification of Structurally Alert Mutagenic Impurities in Meropenem Trihydrate Drug Substance by Liquid Chromatography with High Resolution Mass Spectrometer (LC-HRMS)

  AUTHORS: Anwar Sulaiman, K. Ramakrishna Reddy, Vundavilli Jagadeesh Kumar, Hemant Kumar Sharma

  KEYWORDS: Mutagenic Impurities, LC-HRMS, Meropenem Trihydrate, Method Validation

  JOURNAL NAME: American Journal of Analytical Chemistry, Vol.15 No.3, March 19, 2024

  ABSTRACT: Potential mutagenic impurities in Active Pharmaceutical Ingredient, Meropenem Trihydrate were assessed and a novel analytical method for their quantification was developed and validated. This Liquid Chromatographic method using High Resolution Mass Spectrometer (LC-HRMS) technique is proved to be suitable for simultaneous quantification of all ten identified impurities with required specificity, sensitivity, resolution, precision, accuracy, and other method characteristics as per ICH Guidelines. The acceptable limit of less than 2.9 μg/g was considered for evaluations, based on drug substance dosage and duration of treatment. The method stands most sensitive with a Limit of Detection of 0.35 μg/g, considering the challenge full acceptance criteria as per current regulatory standards.