The aim of this study is the identification, structural characterization, and qualification of a degradation impurity of bisoprolol\nlabeled as Impurity RRT 0.95. This degradation product is considered as a principal thermal degradation impurity identified in\nbisoprolol film-coated tablets. The impurity has been observed in the stress thermal degradation study of the drug product. Using\nHPLC/DAD/ESI-MS method, a tentative structure was assigned and afterwards confirmed by detailed structural characterization\nusing NMR spectroscopy.The structure of the target Impurity RRT 0.95 was elucidated as phosphomonoester of bisoprolol, having\nrelative molecular mass of 406 (positive ionizationmode).Thestructural characterization was followed by qualification of Impurity\nRRT 0.95 using several different in silico methodologies. Fromthe results obtained, it can be concluded that no new structural alerts\nhave been generated for Impurity RRT 0.95 relative to the parent compound bisoprolol. The current study presents an in-depth\nanalysis of the full characterization and qualification of an unidentified impurity in a drug product with the purpose of properly\ndefining the quality specification of the product.
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