OBJECTIVE: To provide ideas for revise and improve the standard and related method of the quality control of benzalkonium chloride in Chinese Pharmacopoeia (2015 edition,Ⅱ). METHODS: The standards and related methods of the quality control of benzalkonium chloride in Chinese Pharmacopoeia (2015 edition,Ⅱ), British Pharmacopoeia (2013 edition), European Pharmacopoeia (7.0 edition) and United States Pharmacopoeia (36 edition) were comprehensively compared. RESULTS: Compared with Chinese Pharmacopoeia (2015 edition,Ⅱ), the standards abroad provided the component and the ratio of the benzalkonium chloride substituted homolog, the method for ammonia compound test had higher sensibility, it also added the test for benzyl alcohol, benzaldehyde and benzyl chloride impurity, as well as the component ratio test and average relative molecular mass calculation. CONCLUSIONS: The standard and related method of the quality control of benzalkonium chloride in Chinese Pharmacopoeia (2015 edition,Ⅱ) still need to be further improved.
关键词
中国药典英国药典欧洲药典美国药典苯扎氯铵质量控制标准方法
Keywords
Chinese PharmacopoeiaBritish PharmacopoeiaEuropean PharmacopoeiaUnited States PharmacopoeiaBenzalkonium chlorideStandard of the quality controlMethod