Establishment of microbial limit test for Adefovir Dipivoxil Tablets
HUANG Lihua LIANG Weiyang CHEN Yukun WU Weiping▲
Key Laboratory of Quality Control of Blood Products, National Medical Products Administration Key Laboratory of Quality Control and Research of Blood Products, Guangdong Drug Administration Biological Product Rome, Guangdong institute for Drug Control, Guangdong Province, Guangzhou 510663, China
Abstract：Objective To establish a method for microbial limit test of Adefovir Dipivoxil Tablets, through microbial limit test for Adefovir Dipivoxil Tablets and method suitability test based on Chinese Pharmacopoeia 2015 edition. Methods According to the four general principles of the Chinese Pharmacopoeia 2015 edition, microbial limit test of 1105 non-sterile products: microbial count method, microbial limit test of 1106 non-sterile products: control bacteria test and microbial limit test standard of 1107 non-sterile drugs. Sample 10 g was taken and pH 7.0 aseptic sodium chloride-peptone buffer was added to 100 mL. The sample was shaken vigorously and dissolved to obtain 1∶10 test solution. The test was conducted according to the plate method (pour method). Results The microbiological limit of Adefovir Dioxidel Tablets was tested by the dish method (pour method), and the lowest dilution level (1:10) was also effective in detecting viable aerobic bacteria, molds and yeast in the drug. The recovery ratio of all tested bacteria was within the range of 0.5-2. And the controlled bacteria grew well. Conclusion A microbial limit test method for Adefovir Dipivoxil Tablets is established.
2019, Vol. 16 
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