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ISSN 2063-5346
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A SENSITIVE AND SELECTIVE LCMS/MS METHOD FOR THE IDENTIFICATION AND QUANTIFICATION OF POTENTIAL GENOTOXIC IMPURITIES IN RIBOCICLIB PURE DRUG AND PHARMACEUTICAL FORMULATIONS

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P. G. Phaneendra Rao1, Battula Sreenivasa Rao2*, Nagulapati Manjula Bharathi3
» doi: 10.31838/ecb/2023.12.si5.013

Abstract

The toxicological valuation genotoxic impurities and assessment of acceptable levels for such impurities in any pure drug and its formulations is a significant as well as very difficult issue. The European Medicines Agency guided that 1.5 μg/day intake of a genotoxic impurity was considered as acceptable for most of the pharmaceutical products. In view of this, the present work was intended to develop a sensitive, simple and accurate LCMS method for the quantification of potential genotoxic impurities (PGIs) such as N-oxide impurity, N-formyl impurity,

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