Quality Analysis of 105 Batches of Domestic Cefetamet Pivoxil Hydrochloride Oral Solid Preparation / 中国药房

ABSTRACT

OBJECTIVE:To provide reference for improving the homogeneity and stability of domestic cefetamet pivoxil hydro-chloride oral solid preparation and its control standrads. METHODS:105 batches of cefetamet pivoxil hydrochloride preparations (tablets,granules,dry suspensions and dispersible tablets)were tested by statutory inspection test in respects of property,identifi-cation,weight difference or load difference,moisture,microbiological limits,related substances,dissolution degree and content, etc.,and results were analyzed. Exploratory research was conducted for its impurity sources,dissolution consistency evaluation, the correlation between the remaining validity period with relative substance and content,etc. RESULTS:Statutory tests showed, 103 batches were qualified in the 105 batches of samples(98.1%). The unqualified items were property and related substances,the other items met relevant regulations. Besides,the determination method for related substances in dispersed tablets was quite differ-ent with other preparations. Results of exploratory research showed the related substances in preparations originated from raw materi-als,degradation reaction in manufacturing or storage. Compared with domestic reference tablets and granules,f2 of dissolution of other products were mostly less than 50;there was no correlation in related substances,content with the remaining validity period. CONCLUSIONS:The 105 batches of domestic oral solid preparation of cefetamet pivoxil hydrochloride are basically qualified;cur-rent standard is basically feasible for tablets,granules and dry suspensions,while the standard for dispersible tablets needed to be improved immediately.