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filingDate 2020-04-27^^<http://www.w3.org/2001/XMLSchema#date>
grantDate 2022-04-12^^<http://www.w3.org/2001/XMLSchema#date>
publicationDate 2022-04-12^^<http://www.w3.org/2001/XMLSchema#date>
publicationNumber CN-111521698-B
titleOfInvention Method for detecting residual solvent in setastine hydrochloride raw material medicine
abstract The invention discloses a method for detecting residual solvent in a setastine hydrochloride raw material medicine. The method is a headspace-gas chromatography (HS-GC) determination method for separating and determining 6 organic solvent residues in setastine hydrochloride by preparing a setastine hydrochloride raw material into a solution, placing the solution in a headspace bottle, heating to volatilize a volatile organic solvent from the solution, injecting upper gas in the headspace bottle into a gas chromatograph after the solution is balanced, and performing separation and determination on the 6 organic solvent residues in setastine hydrochloride. The result shows that 6 residual solvents in the method established by the invention can be effectively separated, and the method has good linear relation and high average recovery rate in the range of the investigated concentration. The method is simple, convenient and sensitive, has accurate and reliable results, is suitable for daily detection of residual solvent in the setastine hydrochloride, and provides reference and basis for revising a residual solvent check item in the quality standard of the product.
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