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| Test on Sample Potency in 7-ACA Process by Optimized HPLC |
| JIN Xian-rui, XU Yong-long, SUN Zhi-hong |
| Zhongrun Site, CSPC Zhongruo Pharmaceutical(Shijiazhuang ) Corporation Ltd., Shijiazhuang 050041,China |
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Abstract Since the production of steps the updated 7-ACA manufacturing process were reduced,the previous test method should be optimized according to samples composition,the optimized HPLC was used in testing the sample potencys made the samples potency test methods for extraction and enzyme reaction be unified was in favor for comparing main composition and impurities and analyzing their trend.The optimized analytical method was validated. Test condition: C18 chromatographic column; wavelength 254 nm; sodium acetate buffer:acetonitrile=99:1; validation items: specificity, precision, linearity and range, accuracy, robustness. The validated and optimized method could be used to test the sapmple potency in 7-ACA process.
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