Structural characterization of low level degradants in aztreonam injection and an innovative approach to aid HPLC method validation
Journal of Pharmaceutical and Biomedical Analysis(2016)
摘要
•The structures of low level degradants in drug product and API are elucidated.•Degradation pathways for the formations of three new degradants are proposed.•The exact concentrations are determined by qNMR for use as HPLC standards.
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关键词
Aztreonam,Degradants,Identification,Structure elucidation,Quantitative NMR
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