叶酸片有关物质不合格原因分析

Cause Analysis of Unqualified Substances in Folic Acid Tablets

针对叶酸片有关物质检测中发现的最大单个杂质超标问题,从制剂的原辅料、实验过程、影响因素等多方面分析不合格原因。实验结果证实,超标的最大单个杂质定性为杂质A(对氨基苯甲酰谷氨酸),辅料中杂质的引入是不合格的首要怀疑因素。杂质的定性及不合格原因的讨论为药厂优化制剂辅料,严格叶酸片的质量控制提供依据。

In view of the problem of single impurity exceeding the standard found in the detection of folic acid tablets,the unqualified reasons were analyzed from the aspects of the preparation raw materials,experimental process and influencing factors.The experimental results confirmed that the largest single impurity exceeding the standard was identified as impurity A,and the introduction of impurities in the excipients was the primary suspect factor of unqualified.The qualitative analysis of impurities and the discussion of unqualified causes can provide the basis for pharmaceutical factories to optimize preparation excipients and strictly control the quality of folic acid tablets.