Methodology Validation of Microbial Limit Test for Ciprofloxacin Hydrochloride
To establish a microbial limit test method for ciprofloxacin hydrochloride.According to General Principles 1105 and 1106 of Chinese Pharmacopoeia Edition 2020,magnesium ions in magnesium sulfate solution of 0.5 g/mL form chelate with carboxyl group and ketocarbonyl group at positions 3,4 in ciprofloxacin hydrochloride structure,neutralize its bacteriostasis ability,adopt membrane filtration method,and rinse and filter with sodium chloride-peptone buffer solution of pH 7.0.The recoveries of aerobic bacteria,mould and yeast were between 50%-200%,and the suitability test of Escherichia coli(control bacteria test)met the requirements.The method can be used for microbial limit counting and control bacteria detection of ciprofloxacin hydrochloride.
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