头孢泊肟酯进口标准英文

头孢泊肟酯进口英文 The import registration standard for cefpodoxime proxetil Cefpodoxime proxetil CHNOS 557.60 2127592 5-Thia-1-azabicyclo[4.2.0]oct-2-ene-carboxylic acid, 7-[[(2-amino-4-thiazolyl) (methoxyimino) acetyl]amino] -3-(methoxymethyl)-8-oxo-,1-[[(1-methylethoxy)carbonyl]oxy]ethyl ester, [6R-[6α,7β(Z)]]-. (?)-1-Hydroxyethyl(+)-(6R,7R)-7-[2-(2-amino-4-thiazolyl)glyoxylamido]-3- methoxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate,72-(Z)-(O-methyloxime), isopropyl carbonate (ester). It contains not less than 69.0% and not more than 80.4% of cefpodoxime (C15H17N5O6S2), calculated on the anhydrous basis. Description A white to slightly brown-white powder, Odorless or slightly special smell, taste bitter. Very soluble in acetonitrile and methanol, freely soluble in ethanol, slightly soluble in aether, very slightly soluble in water. Specific rotation Dissolve an accurately weighted quantity in Acetonitrile to produce a test solution of about o o5mg per ml, the specific rotation is +18.3 to +31.4.( CP 2000 volume 2 Appendix ?E) Absorption coefficient Dissolve an accurately weighted quantity in Acetonitrile to produce a test solution of about 1%15μg per ml, determine the absorbance at 234nm, the absorption coefficient(E) is 1cm 324~360.( CP 2000 volume 2 Appendix ?A) Identification (1) The infrared absorption spectrum is concordant with the reference spectrum of Cefpodoxime proxetil. (2) the retention time of Cefpodoxime proxetil isomer A and B of the substance being examined in the chromatogram is identical with that of Cefpodoxime proxetil isomer A and B of the reference solution in the chromatogram obtained in the Assay. Clarity and colour of solution Dissolve 1.5g in 10ml methanol, the solution is clear and colourless, or maple; dissolve 0.5g in 10 ml methanol, the solution is clear and colourless, Any colour produced, examined as specified method(CP 2000 volume 2 Appendix ?A) xxxx Isomers Carry out the method for high performance liquid chromatography(CP 2000 volume 2 Appendix ?D). The radio of isomer B of cefpodoxime proxetil to the sum of the isomers A and B of cefpodoxime proxetil is between 0.5~0.6. Methanol、Acetaldehyde, ethyl acetate, cyclohexane, isopropanol, toluene Carry out the method for gas chromatography(CP 2000 volume 2 Appendix ?E). System Suitability 6%cyanopropyophenyl-94%dimethylpolysiloxane chemical crosslinked fused silica capillary column(film thickness 1.5μm) 30m×0.53mm; carrier gas is nitrogen; the injector temperature is 120?;use the method of programmed temperature, the initial temperature is 35?，maintain it for 5min，then raise the temperature at a rate of 35? per min to 250?，maintain it for 5min. Inject 1μl of the reference solution into column, the resolution of the Acetaldehyde and methanol comply with the requiments. Procedure Accurately weight ethyl acetate, methanol , toluene separately for 20mg, cyclohexane for 30mg, and isopropanol, Acetaldehyde separately for 10mg to 10ml volumetric flask, add DMF to dilute to volume, transfer 50μl to another 10ml volumetric flask, add DMF to volume, as the reference solution; Weight the substance 200mg accurately to 5ml volumetric flask, accurately add 2ml DMF, as the test solution. Inject 1μl of the reference solution and the test solution separately into the column, and record the chromatogram. Calculate the content of Methanol、Acetaldehyde, ethyl acetate, cyclohexane, isopropanol and toluene in the test substance by external standard method. The content of Methanol and ethyl acetate is not more than 0.1% (g/g); the content of toluene is not more than 0.089% (g/g); the content of Acetaldehyde and isopropanol is not more than 0.05% (g/g); the content of cyclohexane is not more than 0.15% (g/g). Water Not more than 3.0%( CP 2000 volume 2 Appendix ?M，method 1,A). Related substances Dissolve an accurately weighed quantity of the substance being examined in an acetonitrile solution with citric acid(0.01?100) to produce a solution of about 2mg per ml as test solution; dilute an accurately measured quantity with acetonitrile to produce a reference solution of 0.1μ g per ml, as a pre-test solution. Carry out the method as described under Assay, adjust the flow (about 1ml/min), the retention time of isomer B is about 30 min, and the relative retention time of isomer A is about 0.79, the relative retention time of isomer B is 1.0, the resolution of isomer A and B is not more than 4. Inject 10μl of the pre-test solution into the column, adjust the attenuation so that the peak of cefpodoxime proxetil isomer A and B be detected, then inject 10μl of the test solution into the column, and record the chromatograms for 2 times the retention time of Cefpodoxime proxetil isomer B, the area of relative retention time about 0.85 is not more than 4 times of the sum of the area of all peaks(4.0%); the area of each peak of other impurities is not more than 2 times of the sum of the area of all peaks(2.0%); the sum of the area of all impurities is not more than 8 times of the sum of the area of all peaks(8.0%). Residue on ignition Not more than 0.5%( CP 2000 volume 2 Appendix ?N), using 1.0g. Heavy metals Not more than 0.002%(20ppm)(CP 2000 volume 2 Appendix ?H, method 1),using 1.0g. Assay Carry out the method for high performance liquid chromatography(CP 2000 volume 2 Appendix ?D). Using a column packed with phenyl bonded silica gel and a mixture of phosphate buffer(dissolve monopotassium phosphate 0.68g in water and dilute to 1000ml, adjust pH6.5 with potassium hydroxide )-[ acetonitrile-methanol (75:25)] (61:39) as the mobile phase. The detection wavelength is 260nm. Dissolve an accurately weighted quantity of cefpodoxime proxetil reference substance(CRS) in diluent[water-acetonitrile-methanol (40:15:45)] to produce a test solution of 0.1mg per ml. inject the solution into the column and record the chromatogram. The resolution between isomer A, B is not less than 4.3, the tailing factor is not more than 1.5, calculate the results of a number of injections, and the relative standard deviation(RSD) is not more than 2.0%. Procedure weight accurately a quantity(equivalent to Cefpodoxime 50mg) to 50ml volumetric flask, dissolve in 5ml methanol, then dilute to volume with diluent, a test solution of 0.1mg per ml is prepared. Inject 20μl into the column and record the chromatogram; repeat the operation, using cefpodoxime proxetil CRS instead of the substance being examined, calculate the content of CHNOS with respect to the sum of the area of the isomer A and B 1517562 Obtained in the chromatogram by external standard method. Category β-lactam antibiltic, Cephalosporin. Storage preserve in tightly closed containers, stored in a cool place and protected from light.