| Cefminox Sodium is one of cephamycin antibiotic, developed by Japan Mei ji Seika kaisha Ltd. This drug was first marketed in Japan 1987, and recorded in Japanese Pharmacopoeia. Now this drug has been marketed in China domestic. But most of this drug used in clinical are imported products. This drug is under generic development stage in China domestic.The reported synthetic methods of Cefminox Sodium were analyzed and discussed in this paper. The synthetic technology of Cefminox Sodium was determined and established by small scale and optimization experiments, and validated by pilot scale experiments. The commercial batch production of Sterile Cefminox Sodium for Injection can be realized. IR, UV, MS, NMR and X-Ray results indicated that the qualities of the generic sample are same as the original product.According to New drug (Chemical drug) Research Guidance, this paper also studied the quality specification of Cefminox Sodium. It includes: identification, pH, Clarity and color of solution, related substance, and assay, etc. Validation of analytical method (Specificity, Accuracy, Repeatability, Linearity and Range, etc.) was validated, according to China Pharmacopoeia (2005 Edition) Vol. II Appendix XIX A. The validation results conform to the related requirements. It will be the surporting data for quality evaluation in drug registration stage and quality control in commercial batch manufacturing.
|
PDF Full Text Request