Abstract：Abstract Objective To establish a microbial limit test method of low endotoxin sucrose, and carry out the verification of this methodology. Methods According to the general rules 1105 microbiological examination of non-sterile products: Microbial enumeration tests, the general rules 1106 microbiological examination of non-sterile products: Tests for specified microorganisms and the general rules 1107 microbiological examination standards of non-sterile products in the appendices volume Ⅳof Chinese Pharmacopeia (edition 2015), the inspection method was examined by the suitability test. It makes suitability test for inspection method. In addition, the samples were examined by means of the established method. Results Recoveries of trial bacteria were between 0.5 to 2.0, and the controlled bacteria grew well. The samples could pass the validation test of Chinese Pharmacopoeia 2015 version. Conclusion It was proved that this method was effective and feasible, and it could be used in microbial limit test of low endotoxin sucrose.
陈英杰1 刘华2 李炎2 温姣琳3 万丽1,*. 低内毒素蔗糖微生物限度检查方法的适用性试验[J]. 中国抗生素杂志, 2018, 43(6): 705-708.
Chen Ying-jie,Liu Hua,Li Yan,Wen Jiao-lin and Wan Li. Applicability test of the microbial limit test for low endotoxin sucrose. CJA, 2018, 43(6): 705-708.