14-04-2023 дата публикации
Номер: CN115963190A
Принадлежит:
The invention provides a method for detecting the content of pivaloyl chloride in a cephalosporin antibiotic bulk drug, which comprises the following steps: A) taking a pivaloyl chloride reference substance, adding a diluent, and mixing to obtain a reference substance solution; the method comprises the following steps: taking a cephalosporin antibiotic bulk drug, adding a diluent, and mixing to obtain a test sample solution; and B) respectively determining the test sample solution and the reference substance solution by headspace sampling-gas chromatography-mass spectrometry, quantifying by an external standard method, and determining the content of pivaloyl chloride in the test sample solution. The method solves the problems that existing impurities are unstable, the solubility of raw material medicines is poor, and the detection limit does not meet the limit requirement of the raw material medicines, and is simple and rapid to operate and high in qualitative specificity; the quantification ...
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