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目的检查阿莫西林胶囊有关物质项,由于检验中对标准叙述理解的不同,产生了不同的方法,现讨论其机理。方法共有4种,A法(对照品对照法)、B法(峰面积归一化法)、C法(供试品1%浓度自身对照法)、D法(标示量法)。结论4种方法都存在密切的联系,也有各自的特点,C法最优,但根据《中国药典》的表述应采用D法。
Aim To examine the related substances of amoxicillin capsules, different methods have been developed due to the different comprehension of the standard narration in the test, and the mechanism is discussed now. A total of 4 methods, A method (reference standard control method), B method (peak area normalization method), C method (for the test 1% concentration of self-control method), D method (labeled amount method). Conclusion All four methods are closely related and have their own characteristics, C method is the best, but according to the “Chinese Pharmacopoeia” statement should be used D method.