Methodological study on microbial limit test of carboxymethyl starch sodium
10.19778/j.chp.2024.06.011
- VernacularTitle:羧甲淀粉钠微生物限度方法适用性试验研究
- Author:
Yazong YANG
1
;
Jin GAO
1
;
Hemeng WANG
1
;
Ning MAO
1
;
Bo YU
1
;
Yongliang QI
1
Author Information
1. 北京协和药厂有限公司,北京 102600
- Publication Type:Journal Article
- Keywords:
carboxymethyl starch sodium;
microbial limit test;
suitability of method;
neutralization method;
polysorbate 80;
lecithin
- From:
Drug Standards of China
2024;25(6):596-599
- CountryChina
- Language:Chinese
-
Abstract:
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.
