Quality evaluation of cefoperazone sodium for injection
Objective This study evaluated the quality condition of domestic and imported cefoperazone sodium for injection.Methods The statutory standard methods combined with exploratory research were used to evaluate the quality of the 66 batches of samples from the national drug market and from pharmaceutical manufacturers.Results The legal test results showed that the qualified rate of 66 batches of cefoperazone sodium for injection was 100％.But exploratory research showed that the specificity of the related substance method of ChP2020 was not good;the limits were broad,so it was difficult to guarantee safety.The related substance method with strong specific properties was established,which could control polymer impurities at the same time.The samples from some pharmaceutical manufacturers detected a trace mount of genetic impurity NDMA.It was suggested that pharmaceutical manufacturers should strengthen the monitoring of raw material production.There were also some problems in domestic samples,such as crystal coalescence;the particle size distribution was not uniform;and the resolution time was long,which all indicated that the crystallization process of domestic raw materials still had much to be improved.The compatibility results showed that the rationality of the compatibility diluents recommended in the instructions of some pharmaceutical manufacturers was questionable.The results of the influence factors and the accelerated test,combined with the storage conditions of pharmacopoeia from various countries,showed that there may be certain risks associated with samples being stored in a cool,dark place at 25 ℃.The results of package material compatibility showed that the quality of the sample could be improved by the coated rubber plug and the medium-borosilicate glass bottle.Conclusion The quality of domestic cefoperazone sodium for injection at present is normal.The current statutory standard needs to be improved.It is suggested that pharmaceutical manufacturers optimize the crystallization process of raw materials and choose better-quality packaging materials.
Cefoperazone sodium for injectionQuality evaluationSecurityEffectivenessCompatibilityStabilityPackage compatibility
万方数据
维普
