Verification of the Test for the Detection of Specified Micro-organisms in the 17th Edition of the Japanese Pharmacopoeia <5.02> Microbial Limit Test for Crude Drugs and Preparations Containing Crude Drugs as the Main Ingredient

Abstract

Among the test methods for specified micro-organisms described in <5.02> Microbial Limit Test for Crude Drugs and Preparations containing Crude Drugs as the Main Ingredient, which was revised in the 17th edition of the Japanese Pharmacopoeia, those for Escherichia coli, Salmonella and Bile-tolerant gram-negative bacteria were verified. An antimicrobial activity of crude drugs against E. coli and Salmonella was essentially not observed. The effectiveness of chromogenic medium was shown by confirmation of contaminating bacterial influence on the tests of E. coli and Salmonella. For the test of Bile-tolerant gram-negative bacteria, a comparative test of the previous and new test methods was performed, and it was confirmed that the new test method had the tendency to lead to a higher value of probable number. In conclusion, it was confirmed that the test methods had sufficient accuracy and detection sensitivity.