Abstract:
OBJECTIVE To establish a microbial limit test method of Deferasirox Dispersible tablets.
METHODS According to the fourth volume of Chinese Pharmacopoeia(the 2015 Edition), general rule 1105:microbial counting method for microbial limit test of non-sterile products, general rule 1106:the control bacteria examination method for microbial limit test of non-sterile products, general rule 1107:the test method for suitability of microbiological limits for non sterile drugs. Several methods were tried in the suitability of microbial limit test. When the samples were diluted in pH 7.0 sodium chloride buffer-peptone solution (containing 3% Tween-80, 0.3% lecithin) and were made a 1 in 500 dilution (the total aerobic microbial count), 1 in 50(the total yeast and mold count). A plate method was used in the total aerobic microbial count and the total yeast and mold count. The direct inoculation method was used for the detection of
Escherichia coli(500 mL TSB).
RESULTS The recoveries of the five strains were from 0.5 to 2.0.
CONCLUSION The method is suitable for the microbial limit examination of Deferasirox Dispersible tablets.