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The establishment of microbial limit test method of Dabigatran Etexilate Mesylate Capsules
Pages: 589-591
Year: Issue:  10
Journal: Qilu Pharmaceutical Affairs

Keyword:  Dabigatran Etexilate Mesylate CapsulesMicrobial limits testValidation;
Abstract: Objective To establish a method of microbial limit test for Dabigatran Etexilate Mesylate Capsules. Meth-ods Validation of microbiological limit tests according to Chinese Pharmacopoeia edition 2010. Results Dabigatran Etex-ilate Mesylate Capsules has strong inhibiting effect on Bacillus subtilis and Staphylococcus aureus in bacterium. Conclusion The membrane filtration method was used in the test of bacterium. The routine method was used in the test of mold and yeasts. The routine method was used in the test of pathogenic bacterium.
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