Abstract:
OBJECTIVE To establish a method for microbial limit test of cefixime dispersible tablets, and carry out the verification of methodology. METHODS The method for microbial limit test of cefixime dispersible tablets was established by a membrane filtration method of total aerobic microbial count and the plate-count method of the total yeasts and moulds and a membrane filtration method of control of bacterial and the method validation was performed according to the Chinese Pharmacopoeia 2005 version. Negative product control and negative diluent control were proceeded with the test of the product. RESULTS The recoveries above 70% were obtained when comparing the product challenge to its corresponding inoculum control, and no growth was observed in the negative diluent controls. The method could pass the validation test of Chinese pharmacopoeia 2005 version. CONCLUSION The method can be used in microbial limit test of cefixime dispersible tablets.