ABSTRACT
Objective:To establish a microbial counting method for pre-sterilization products of tinidazole and sodium chloride in-jection.Methods:Pre-sterilization product was taken out 100 ml, and according to the established verification test method , the test bacteria were added to the samples and the recovery rate of the tested bacteria was measured .Results: The recoveries of all the test bacteria ( Staphylococcus aureus, Pseudomonas aeruginosa, Bacillus subtilis, Candida albicans and Aspergillus brasiliensis) in the vali-dation test were within the range of 50％-200％, and the results met the requirements of Chinese Pharmacopoeia.Conclusion: The method is effective and feasible , and can be used for the microbiological count of pre-sterilization products .
ABSTRACT
Objective:To establish a method to determine the content of bacterial endotoxin in iodixanol. Methods:The standard curve of kinetic turbidimetric method was established and the dilution ratio was optimized by interference test. Bacterial endotoxin in the samples was determined. Results:The dilution ratio of 1 ∶12 did not interfere with the test. The recovery rate of bacterial endotox-in was 50%-200%. Conclusion:The kinetic turbidimetric method is suitable for the determination of bacterial endotoxin in iodixanol.