Research Of Cefmatazole Sodium Synthesis Process And Quality Specification

Cefmetazole Sodium is a second-generation semisynthetic cephamycin antibiotics,Comparing to the other cephalosporins it is chemically unique in that the cephem nucleusis substituted with a7α-methoxy to increase the steric hindrance of the parent nucleus andits resistance to destruction by bacterial β-lactamase. So it is still active againstbeta-lactamase-producing organisms that are resistant to cephalosporins or penicillins.The reported synthesis progress of Cefmetazole Sodium were analyzed and discussedin this paper. The synthetic technology of Cefmetazole Sodium was determined andestablished through small scale and optimization experiments, and validated by pilot saclemanufacturing finally. The commercial batch production of sterile Cefmetazole Sodium forpowder injection can be realized. EA, IR, UV, MS, NMR, X-ray, DSC and TGA is used tocmfirm with the market product. According to the New Drug (chemical drug) ResearchGuidance, this paper also studied the quality specification of Cefmetazole Sodium. Itincludes:identification, pH, clarity and color of solution, organic solvent residue, relatedsubstance, bacterial endotoxin and assay, etc. Validation of analytical method(Specificity,Accuracy, Repaetability, Linearity and Range etc) was validated. According toCP2010volume II appendix, the validation results comply with related requirements. Itwill be the supporting data for quality evaluation in drug registration phase and qualitycontrol in commercial production in future.