Synthesis,Structure Confirmed And Determination Of Flomoxef Sodium Oxidation Products

Flomoxef sodium is an oxacephem antibiotic,which is divided as the forth generation cephalosporin,it is mainly used as injection in clinical application.In order to ensure the safety of clinical medication,and comprehend the ways of flomoxef sodium degardation,the research group has spent a lot of work for flomoxef sodium oxidative degradation impurities(Abbreviation:FMOX-oxide)?After meta-Chloroperoxybenzoic of flomoxef sodium,through crystallization and other steps,sodium flomoxef oxidation products(FMOX-oxide)crude.Recycling preparative high performance liquid chromatography(HPLC)technique further crude product to obtain high purity sodium flomoxef oxidation products.Make MS and NMR spectroscopic detection on Sodium flomoxef oxidation products and confirm the structure according to the results of spectral analysis.On the basis of the Japanese Pharmacopoeia monograph flomoxef sodium impurity analysis method,by single factor analysis and orthogonal experiment,develop the analytical methods for the determination of FMOX-oxide impurities in flomoxef sodium,and verified.Further destruction experiments and stability studies using a typical batch analysis results and products,oxygen,sodium fluoride in the cephalosporins FMOX-oxide impurity levels are assessed.Through research,we get the FMOX-oxide impurity reference after isolation,and develop the control methods of FMOX-oxide impurities in flomoxef sodium,and then apply it on the monitorting FMOX-oxide impurities in the production.