http://rdf.ncbi.nlm.nih.gov/pubchem/patent/CN-112326860-A

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filingDate 2020-10-30-04:00^^<http://www.w3.org/2001/XMLSchema#date>
inventor http://rdf.ncbi.nlm.nih.gov/pubchem/patentinventor/MD5_f990f1ea7ac8f48b804ef93ae9447ba7
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publicationDate 2021-02-05-04:00^^<http://www.w3.org/2001/XMLSchema#date>
publicationNumber CN-112326860-A
titleOfInvention Method for simultaneous detection of 1,4-dichlorobutane and 1-chloro-4-hydroxybutane genotoxic impurities in drug substance or preparation
abstract The invention relates to the technical field of analysis and detection, in particular to a method for simultaneously detecting genotoxic impurities of 1,4-dichlorobutane and 1-chloro-4-hydroxybutane in raw materials or preparations. The method for the simultaneous detection of 1,4-dichlorobutane and 1-chloro-4-hydroxybutane genotoxic impurities in raw materials or preparations is detected by gas chromatography-mass spectrometry, using EI ion source, headspace For phase analysis, methyl tert-butyl ether was used as the internal standard, and the content of impurities in the sample was calculated by the internal standard method. The present invention solves the problem that the current detection limit of genotoxic impurities cannot be reached, and simultaneously fills the problem of simultaneously detecting 1,4-dichlorobutane and 1-chloro-4-hydroxybutane genotoxic impurities in raw materials or preparations. The vacancy of the method, the detection limit reaches ppm, the sensitivity is improved, the repeatability is good, and the response is high.
priorityDate 2020-10-30-04:00^^<http://www.w3.org/2001/XMLSchema#date>
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