注射用亚叶酸钙有关物质评价研究

Objective Study on the Related Substances of Calcium Folinate for Injection

目的对注射用亚叶酸钙有关物质进行评价分析,为生产、质控提供参考。方法按照国内外药典方法进行有关物质检查,结合水分、pH数据分析影响样品稳定性的因素。通过破坏性试验考察样品中杂质的来源。结果未知杂质1、4、5、8确定为降解杂质,未知杂质3、6、10、11、12可能是降解杂质,未知杂质2、7、9不是降解杂质,为反应或副反应产物。结论样品有关物质稳定性与不同辅料的添加无关;样品在偏碱环境中比偏酸环境更稳定;稳定性试验结果表明注射用亚叶酸钙稳定性较好。

OBJECTIVE To evaluate and analyze the related substances of Calcium Folinate for Injection,so as to provide references for manufacturing and quality control.METHODS The related substances of Samples were tested according to the current pharmacopoeia methods,and data were collected combined with water and pH for statistical analysis.Origins of impurities were found after destructive experiment.RESULTS Unknown impurities 1,4,5 and 8 were identified as degradation impurities while unknown impurities 3,6,10,11 and 12 might be degradation impurities.Unknown impurities 2,7 and 9 were not degradation impurities and might be reaction or side reaction products.CONCLUSION The stability of related substances in the sample is not related to the addition of different excipients;the sample is more stable in alkali environment than in acid environment;the stability test results show that the stability of calcium folinate for injection is better.