Objective:To establish a method for microbial limit test of carboxymethyl starch sodium.Methods:According to the requirements of General chapters 1105 and 1106 of the fourth part of the Chinese Pharmacopoeia 2020,the applicability of microbial limit method for carboxymethyl starch sodium was tested.Results:The test solution diluted with neutralizer to 1∶20 was counted by plate method.The recoveries of each test bacteria were in the range of 0.5-2.Escherichia coli was examined by direct inoculation with 1∶20 test solution,and the results met the requirements.Conclusion:The established neutralizer method is simple and feasible,and can effectively eliminate the bacteriostatic effect of carboxymethyl starch sodium.
关键词
羧甲淀粉钠/微生物限度检查/方法适用性/中和法/聚山梨酯80/卵磷脂
Key words
carboxymethyl starch sodium/microbial limit test/suitability of method/neutralization method/polysorbate 80/lecithin
维普
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