药用辅料山梨醇(供注射用)的细菌内毒素检查法
Bacterial Endotoxin Test for Excipients Sorbitol for Injection Preparations
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摘要: 目的 建立药用辅料山梨醇(供注射用)的细菌内毒素检查法。方法 按中国药典2010年版细菌内毒素检查法相关规定进行试验。结果 本品在0.2 g·mL-1浓度下对细菌内毒素检查无干扰作用。结论 所建立的药用辅料山梨醇(供注射用)的细菌内毒素检查方法具有可行性，其内毒素限值可定为2.5 EU·g-1。Abstract: OBJECTIVE To establish a bacterial endotoxin method for excipients sorbitol for injection preparations. METHODS According to the method in the appendix of the Chinese Pharmacopoeia(2010), the bacterial endotoxin test was carried out. RESULTS The preparation did not interfere with endotoxin test below the concentration of 0.2 g·mL-1. CONCLUSION The method of bacterial endotoxin test is feasible with the limit of 2.5 EU·g-1 for excipients sorbitol for injection preparations.
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