Method for detecting benzene sulfonate genotoxic impurities in cisatracurium besilate medicine
The invention discloses a method for detecting benzene sulfonate genotoxic impurities in a cisatracurium besilate medicine, and belongs to the technical field of medicine analysis and detection. According to the method, liquid chromatography-mass spectrometry is established for simultaneously determ...
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Format: | Patent |
Sprache: | chi ; eng |
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Zusammenfassung: | The invention discloses a method for detecting benzene sulfonate genotoxic impurities in a cisatracurium besilate medicine, and belongs to the technical field of medicine analysis and detection. According to the method, liquid chromatography-mass spectrometry is established for simultaneously determining methyl benzenesulfonate, ethyl benzenesulfonate, propyl benzenesulfonate, isopropyl benzenesulfonate, methyl p-toluenesulfonate, propyl p-toluenesulfonate, isopropyl p-toluenesulfonate and isobutyl p-toluenesulfonate in cisatracurium besylate, and the content of the cisatracurium besylate in the cisatracurium besylate in the cisatracurium besylate in the cisatracurium besylate in the cisatracurium besylate is determined. The method is high in sensitivity, high in accuracy, high in precision and good in linear relation and specificity, meets the detection requirements, is suitable for daily detection of genotoxic impurities in cisatracurium besilate bulk drugs, injections and powder injections for injection, a |
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