Molecular Formula | C20H21N6NaO7S4 |
Molar Mass | 608.65 |
Melting Point | 196 - 207°C |
Solubility | DMSO (Slightly), Methanol (Sparingly) |
Appearance | powder |
Color | White to Off-White |
Storage Condition | 2-8°C |
Stability | Hygroscopic |
Toxicity | LD50 in mice, rabbits (mg/kg): 4000-8000 i.v. both species; in rats (mg/kg): 4000-8000 i.v., 15000-17500 s.c., 8000-11000 i.p. (Bryskier) |
This product is (6R,7R)-7 -[(Z) -2-(2-aminothiazol-4-yl) -2-(methoxyimino) acetamido] -3 -[(5-carboxymethyl-4-methylthiazol-2-yl) thiomethyl 8-oxo-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylic acid disodium salt. Calculated as anhydrous and ethanol-free, the content of C20H20N607S4 shall not be less than 88.0%.
take this product, precision weighing, add water to dissolve and quantitatively dilute to make a solution containing about 10 mg per lml, and determine according to law (General 0621), the specific rotation was from 55 ° to -62 °.
take this product, precision weighing, add water to dissolve and quantitatively dilute to make a solution containing about 20ug per lml, according to UV-visible spectrophotometry (General 0401), the absorbance was measured at a wavelength of 260nm, and the absorption coefficient was 305 to 335.
take this product, add water to make a solution containing O.lg per lml, and determine it according to law (General 0631). The pH value should be 5.5~7.5.
take 5 parts of this product, respectively, add water to make each lml containing cefodizime 0.lg solution, the solution should be clear and colorless; If it is turbid, it should not be more concentrated than the 1# turbidity standard solution (General 0902 first method); If it is colored, no deeper color shall be compared with the yellow or yellow-green standard colorimetric solution No. 9 (General Principles 0901 first method>).
new system for clinical use. Take about 25mg of this product, put it in a 50ml measuring flask, add the mobile phase to dissolve and dilute to the scale, shake well, as the test solution; Take 1ml of the test solution accurately, set in a 100ml measuring flask, dilute to the scale with the mobile phase, and shake to serve as a control solution. According to the chromatographic conditions under the content determination item, the detection wavelength is 215nm, and 20 u1 of the test solution and the control solution are accurately measured and injected into the human liquid chromatograph respectively, record the chromatogram to 6 times the retention time of the main component peak. If there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be greater than the area of the main peak of the control solution (1.0%), the sum of each impurity peak area shall not be greater than 1.5 times (1.5%) of the main peak area of the control solution.
new system for clinical use. Take appropriate amount of this product, precision weighing, add water to dissolve and quantitatively dilute to make a solution containing 0.5mg of cefodizime per lml, as a test solution; Take an appropriate amount of cefodizime reference, A solution containing about 5ug per 1ml was prepared as a control solution by precise weighing, dissolving with water and quantitatively diluting. Determined by size exclusion chromatography (General 0514). With spherical hydrophilic silica gel (molecular weight of 1000~10000) as the filler; Phosphate buffer (pH 7.0 )[0.0 5mol/L disodium hydrogen phosphate solution -0.005mol/L sodium dihydrogen phosphate solution (61:39 )]-acetonitrile (95:5) as mobile phase, flow rate of 0.8ml per minute, detection wavelength of 231mn. Take 10ml of test solution and add 0.1 mol/ L sodium hydroxide solution 1ml, room temperature for 10 minutes, plus 0.1 mol/ L hydrochloric acid solution 1ml, shake well, inject 20u1 into liquid chromatograph, record chromatogram; The separation degree between cefodizime peak and its adjacent degradation impurity peak should meet the requirements. Accurately take 20 u1 of the test solution and the control solution, respectively inject human liquid chromatograph, record the chromatogram; If there are impurity peaks in the chromatogram of the test solution, the total amount of impurity peaks with retention time less than cefodizime peak shall not exceed 1.5% calculated by external standard method with cefodizime peak.
take about 0.2g of this product, precision weighing, top empty bottle, precision plus internal standard solution (take a proper amount of N-propanol, dilute with water to make a solution containing lmg per lml) 2ml to dissolve, seal, as a test solution; Respectively, precision weighing dichloromethane 60mg, acetonitrile 41mg and ethanol about 2.0g, put in 50ml measuring flask, diluted to the scale with internal standard solution, shake well, take 5ml accurately, put it in a 100ml measuring flask, dilute it to the scale with internal standard solution, shake well, take 2ml accurately, put it in a top empty bottle, seal it, and use it as a reference solution. Determined according to the residual solvent assay (General 0861 first method). The capillary column with polyethylene glycol (PEG-20M)(or similar polarity) as stationary liquid was used as the chromatographic column, and the column temperature was 40°C; The detector temperature was 250°C; The inlet temperature was 200°C; the Headspace bottle equilibration temperature was 60°C and the equilibration time was 30 minutes. Take the reference solution into the headspace, record the chromatogram, and the separation degree between the chromatographic peaks shall meet the requirements. The test solution and the reference solution are injected in Headspace respectively, and the chromatograms are recorded. The residual amount of ethanol shall not exceed 2.0% based on the peak area ratio calculated by the internal standard method; The residual amount of acetonitrile and dichloromethane shall meet the requirements. 2-ethylhexanoic acid take the right amount of this product, according to the determination (General 0873), shall not exceed 0.5%.
take this product, according to the moisture determination method (General 0832 first method 1), the water content shall not exceed 4.0%.
This product l.Og, inspection according to law (General Principles 0821 second law), containing heavy metals shall not exceed 20 parts per million.
take 5 parts of this product, each 2.0g, respectively, plus particle inspection water dissolution, inspection according to law (General 0904), should comply with the provisions. (For aseptic dispensing)
take this product, Add particle inspection water to dissolve and make a solution containing 30mg per lml, place it for 10 minutes, check according to law (General rule 0903), each lg sample containing 10um and 10um above the particle shall not exceed 6000, containing 25um and 25um above the particle shall not exceed 600. (For aseptic dispensing)
take this product, check according to law (General rule 1143), the amount of endotoxin per 1 mg of cefodizime should be less than 0.10EU. (For injection)
take this product, dissolve and dilute with appropriate solvent, after membrane filtration treatment, inspection according to law (General rule 1101), should comply with the provisions. (For aseptic dispensing)
measured by high performance liquid chromatography (General 0512).
silica gel bonded with OCTA alkyl silane as filler; Phosphate buffer (take potassium dihydrogen phosphate 0.87g and anhydrous disodium hydrogen phosphate 0.22g, add water to dissolve and dilute to 1000ml, shake well)-acetonitrile (920:80) mobile phase; The detection wavelength was 262mn. Take 10ml of the control solution and add 0.1 mol/L hydrochloric acid solution 1 ml, room temperature for 24 hours, plus 0.lmol/L sodium hydroxide solution 1 ml, shake well, take 20ul injection liquid chromatograph, cefodizime peak and before and after the adjacent degradation of impurity peak separation degree should be greater than 3.0 and 4.0.
take an appropriate amount of this product, weigh it accurately, add water to dissolve and quantitatively dilute it to make about 0. 5% cefodizime per 1 ml. 1 mg solution, shake, as a test solution, the precision of 20ul injection of human liquid chromatography, record chromatogram; Another appropriate amount of cefodizime reference, the same method for determination. The content of C20H20O7S4 in the sample was calculated by the peak area according to the external standard method.
B-lactam antibiotics, cephalosporins.
sealed and stored in a cool dark dry place.
This product is a sterile powder of cefodizime sodium. The content of cefodizime (C20H20N607S4) shall not be less than 86.0% calculated as no water; The content of cefodizime (C20H20N607S4) shall be 90.0% ~ 110.0% of the label amount calculated as the average loading.
This product is white to yellowish powder or crystalline powder; Odorless or slightly specific odor.
According to the identification test under the item cefodizime sodium, the same results were shown.
The content under the item of loading amount difference was taken and measured according to the method of cefodizime sodium.
with cefodizime sodium.
specification
calculated as C20H20N607S4 (l)0.25g (2 )0.5g(3)1.0g (4)1.5g (5) 2.og
sealed and stored in a cool dark dry place.