Molecular Formula | C21H27N5O9S2 |
Molar Mass | 557.6 |
Density | 1.58±0.1 g/cm3(Predicted) |
Melting Point | 111-113°C |
Solubility | Soluble in DMSO |
Appearance | neat |
Color | White to Pale Yellow |
pKa | 8.13±0.60(Predicted) |
Storage Condition | Keep in dark place,Inert atmosphere,Store in freezer, under -20°C |
Sensitive | Light Sensitive |
Refractive Index | 1.67 |
Physical and Chemical Properties | White to taupe white powder, odorless or slightly odorous, bitter in taste. Very soluble in methanol or acetonitrile, soluble in ethanol, slightly soluble in ether, very slightly soluble in water. Acute toxicity LD50 male and female mice, male and female rats (mg/kg):>10000,>10000,>2000,>2000 subcutaneous injection; 3502,2535,>4000,>4000 intraperitoneal injection;>8000,>8000,>4000,>4000 oral. |
Use | Antibiotics |
Hazard Symbols | Xi - Irritant |
Risk Codes | R36/37/38 - Irritating to eyes, respiratory system and skin. R42/43 - May cause sensitization by inhalation and skin contact. |
Safety Description | S22 - Do not breathe dust. S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S36/37/39 - Wear suitable protective clothing, gloves and eye/face protection. |
WGK Germany | 3 |
RTECS | XI0367370 |
HS Code | 30042000 |
Toxicity | LD50 in male, female mice, male, female rats (mg/kg): >10000, >10000, >2000, >2000 s.c., 3502, 2535, >4000, >4000 i.p.; >8000, >8000, >4000, >4000 orally (Nakao, 1988) |
(6R,7R)-3-methoxymethyl-7-[2-(2-amino-4-thiazolyl)-2-[(Z)]-Methoxyimino] acetamido]-8-oxo-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylic acid-(brother 5)-1-(isopropoxyformyloxy) ethyl ester. Containing no less than 69.0% cefpodoxime (C15H17N5O6S2), calculated as anhydrous.
This product is white to light yellow powder; Odorless or micro-special odor this product is very soluble in acetonitrile or methanol, soluble in anhydrous ethanol, almost insoluble in water.
take this product, precision weighing, add acetonitrile to dissolve and quantitative dilution to make about 5mg per lml of solution, according to the law (General 0621), the specific rotation should be 18.3 ° to 31.4 °.
The test was performed by high performance liquid chromatography (General 0512).
with eighteen alkyl silane bonded silica gel as filler (4.6mm X 150mm,5um or performance equivalent column), water-methanol-formic acid (600:400:1) as mobile phase A, water-methanol-formic acid (50:950:1) was used as mobile Phase B, and linear gradient elution was carried out according to the following table. The detection wavelength was 254mn, and the flow rate was 0.6ml per minute. Add an appropriate amount of cefpodoxime proxetil reference substance (about 50mg equivalent to cefpodoxime oxime) into a 50ml measuring flask, and add an appropriate amount of diluted solvent [Water-acetonitrile-acetic acid (99:99:2 )] to dissolve, after irradiating with ultraviolet lamp for 12 hours, add 3ml of 30% hydrogen peroxide solution, place it for 60 minutes, dilute it to the scale with the above dilution solvent, shake it well, use it as the applicable solution for the system, and inject 2ou1 into the liquid chromatograph, the chromatogram was recorded, cefpodoxime proxetil isomer A, impurity C, impurity D-I, cefpodoxime proxetil isomer B and impurity D-II were peaked in sequence, and the retention time of cefpodoxime proxetil isomer B peak was about 68 minutes. The resolution between cefpodoxime proxetil isomer peak A and peak B should be greater than 4.0, cefpodoxime proxetil isomer peak A and impurity peak C, impurity D-I and cefpodoxime proxetil isomer peak B, the resolution between cefpodoxime proxetil isomer B peak and impurity D-II peak should meet the requirements.
take an appropriate amount of this product, precision weighing, and add the above dilution solvent to dissolve and dilute to make about 1 of cefpodoxime per 1 ml. 0 mg solution, as a test solution; An appropriate amount was taken in a precise amount, and quantitatively diluted with the above dilution solvent to make about cefpodoxime in 1 ml. Olmg solution, as a control solution. 20 u1 of the test solution and the control solution were respectively injected into the liquid chromatograph, and the chromatograms were recorded. If there are impurity peaks in the chromatogram of the test solution, the peak area of cefpodoxime (impurity A) shall not be greater than 0.5 times (0.5%) of the total area of the two main peaks of the control solution, the Peak area of impurity B- I shall not be greater than the sum of the two main peak areas of the control solution (1.0%), and the sum of the peak areas of impurity C and impurity B- II shall not be greater than the sum of the two main peak areas of the control solution (2.0% ), the sum of the peak areas of impurity D-I and impurity D-II shall not be greater than the sum of the two main peak areas of the control solution (1.0%), the sum of the peak areas of impurity F-I and impurity F-II shall not be greater than 0.2 times (0.2%) of the sum of the two main peak areas of the control solution, the Peak area of impurity G shall not be greater than 0.2 times (0.2%) of the sum of the two main peak areas of the control solution, and the sum of the peak areas of impurity H-I and impurity H-II shall not be greater than the sum of the two main peak areas of the control solution (1.0%), other single impurity peak area shall not be greater than 0.1 times (0.1%) of the sum of the two main peak areas of the control solution, and the sum of each impurity peak area shall not be greater than 4 times (4.0%) of the sum of the two main peak areas of the control solution. Test Solution chromatogram is less than the control solution of the two main Peak area of 0.05 times the peak ignore not Based on.
In the chromatogram of the test solution recorded under the content determination item, the ratio of the peak area of cefpodoxime proxetil isomer B to the peak area sum of cefpodoxime proxetil isomers A, B should be 0.50 to 0.60.
methanol, acetone, isopropanol, acetonitrile, dichloromethane, butanone, ethyl acetate, Tetrahydrofuran, carbon tetrachloride, cyclohexane, benzene, 1, 2-dichloroethane, isopropyl acetate, dioxane, methyl isobutyl ketone, pyridine, toluene and butyl acetate were determined according to the residual solvent determination method (General 0861).
A capillary column with 6% cyanopropylphenyl-94% dimethylpolysiloxane as the stationary liquid (or similar polarity) is used as the column, and the starting temperature is 40°C, and the retention time is 22 minutes, then the temperature is increased to 100°C at a rate of 120°C per minute for 10 minutes. The temperature of the injection port is 200°C, the temperature of the detector is 250°C, and the equilibrium temperature of the headspace bottle is 70°C, the equilibration time was 30 minutes. The system applicable solution is sampled by Headspace injection, and the peaks are generated in the order of n-propanol (internal standard), butanone and ethyl acetate, and the separation degree between peaks shall meet the requirements.
an appropriate amount of N-propanol was taken and diluted with dimethyl sulfoxide to prepare a solution containing about 200ug per 1ml as an internal standard solution. Preparation of applicable solution of the system appropriate amount of methyl ethyl ketone and ethyl acetate were taken and diluted quantitatively with internal standard solution to make a solution containing about 1 mg of butyl charge and ethyl acetate in each lml, and then 1ml was taken for precise measurement and placed in a top-empty bottle, sealed as a solution for system suitability.
take about 0.2g of this product, weigh it accurately, place it in the top empty bottle, add 1 ml of internal standard solution to dissolve it, seal it, and use it as the test solution.
a control solution was prepared according to the specific test object determined by the test. The appropriate amount of each solvent is accurately weighed and diluted quantitatively with the internal standard solution to prepare the solution of the specified concentration as the mixed reference solution, the concentration of each solvent in the mixed reference solution was 600ug of methanol, lmg of acetone, lmg of isopropanol, 82ug of acetonitrile, 120ug of dichloromethane, 1 mg of butanone, 1 mg of ethyl acetate, 150ug of tetrahydrofuran, carbon tetrachloride lug, cyclohexane 760ug, benzene 1ug, 1, 2-dichloroethane 1ug, isopropyl acetate lmg, dioxane 76ug, methyl isobutyl ketone lmg, pyridine 40ug, toluene 178ug, butyl acetate lmg. 1ml of the mixed reference solution was accurately measured, placed in a top empty bottle, sealed, and used as a reference solution.
first take the methane gas headspace injection, record the retention time of methane as the dead time (to) of the chromatographic system, then take the sample solution headspace injection, record the chromatogram, if there are chromatographic peaks in the chromatogram of the test solution, calculate the relative adjusted retention time (RART) of the retention time (tR) of each chromatographic peak relative to the retention time (tR) of n-propanol according to the following formula: compare the obtained RART value with the RART value in the following table to determine the type of residual solvent in the test sample; Prepare the corresponding reference solution, take the headspace injection of the reference solution, record the chromatogram, according to the internal standard method to calculate the peak area ratio, the residual amount of methyl isobutyl ketone shall not exceed 0.5%, methanol, acetone, isopropanol, acetonitrile, dichloromethane, butyl, ethyl acetate, Tetrahydrofuran, carbon tetrachloride, cyclohexane, benzene, residues of 1-2 dichloroethane, isopropyl acetate, dioxane, pyridine, toluene and butyl acetate shall comply with the regulations.
take about 0.2g of this product, put it in a 10ml measuring flask, add methanol to dissolve and dilute to the scale, shake well, as a test solution; Take N, N-dimethylformamide and dimethyl sulfoxide, A solution containing 17.6ug of N, N-dimethylformamide and 100ug of dimethyl sulfoxide respectively per 1 ml was prepared by quantitative dilution with methanol as a reference solution. According to the determination method of residual solvent (General Principle 0861 third method), the capillary column with 5% phenyl-95% dimethyl polysiloxane (or similar polarity) as the stationary liquid is used as the column, the starting temperature is 70°C, and the maintenance time is 12 minutes, then the temperature is raised to 120°C at a rate of 50°C per minute for 10 minutes; The temperature of the injection port is 200°C, the temperature of the detector is 250°C, and the reference solution is directly injected according to N ,N-dimethylformamide, dimethyl sulfoxide peaks in sequence, the separation between the two peaks should meet the requirements.
The Test Solution and the reference solution are injected separately, the chromatogram is recorded, and the residual amounts of N,N-dimethylformamide and dimethyl sulfoxide are calculated by the peak area according to the external standard method.
take this product, according to the moisture determination method (General 0832 first method 1), the water content shall not exceed 3.0%.
take l.Og of this product and check it according to law (General rule 0841). The residue left shall not exceed 0.2%.
The residue left under the item of taking the ignition residue shall not contain more than 20 parts per million of heavy metal when examined by law (General rule 0821, Law II).
measured by high performance liquid chromatography (General 0512).
silica gel bonded with eighteen alkyl silane was used as a filler; Water-methanol (55:45) was used as a mobile phase; The detection wavelength was 240nm; And the column temperature was 40°C. An appropriate amount of cefpodoxime proxetil reference substance was taken, dissolved with an appropriate amount of methanol, and then diluted with mobile phase to make A solution containing about 1 mg of cefpodoxime oxime per 1 ml. 20ul was injected into the liquid chromatograph, and the chromatogram was recorded, the order of B peaks, the separation degree between cefpodoxime proxetil isomers A, B peaks should be greater than 4.0; Cefpodoxime proxetil isomers A peak and adjacent impurity peaks, the resolution between cefpodoxime proxetil isomer B peak and adjacent impurity peaks shall meet the requirements.
take this product, precision weighing, add an appropriate amount of methanol to dissolve, and then quantitatively dilute with mobile phase to prepare a solution containing about 0.3mg of cefpodoxime per 1 ml as a test solution, the chromatogram was recorded by injection of 20u1 into a human Liquid Chromatograph. An appropriate amount of cefpodoxime proxetil was also taken for determination by the same method. The content of C15H17N506S2 in the test article was calculated according to the peak area of cefpodoxime axetil isomers A, B and external standard method.
B-lactam antibiotics, cephalosporins.
sealed and stored in a cool and dry place.
This product contains cefpodoxime proxetil by cefpodoxime oxime (C15H17N506S2) should be the label amount of 90.0% ~ 110.0%.
This product is granular powder or powder.
In the chromatogram recorded under the content determination item, the retention time of the two main peaks of the test solution should be consistent with the retention time of the two main peaks of the control solution.
take an appropriate amount of content (about 30mg equivalent to cefpodoxime) under the difference of loading amount, put it in a 100ml measuring flask, add an appropriate amount of fermentation broth to dissolve, and dilute it to the mark with mobile phase, shake well, filter, take the filtrate, as a test solution, according to the method under the item of cefpodoxime proxetil, that is obtained.
Same as cefpodoxime proxetil.
50mg (based on C15HI7N506S2)
sealed, stored in a cool and dry place.
This product contains cefpodoxime proxetil by cefpodoxime oxime (C15HI7N506S2) should be the label amount of 90.0% ~ 110.0%.
This product is a film-coated tablet, white to yellowish after removing the coating.
Take 10 tablets of this product, precise weighing, fine grinding, precise weighing to take an appropriate amount of fine powder (about equivalent to cefpodoxime 30mg), put it in a 100ml measuring flask, add an appropriate amount of methanol to dissolve, then dilute to scale with mobile phase, shake, filter, take the filtrate, as a test solution, according to the method under the item of cefpodoxime proxetil, obtained.
Same as cefpodoxime proxetil.
Based on C15HI7N506S2 (l)50mg (2)100Mg
sealed and stored in a cool and dry place.
This product contains cefpodoxime proxetil by cefpodoxime oxime (C15H17N5O6S2) should be the label amount of 90.0% to 110.0%.
This product is a capsule, the content of white to yellowish powder or granules.
appropriate amount of content (about equivalent to 30mg of cefpodoxime) under the difference of loading amount shall be accurately weighed and placed in a 100ml measuring flask, and methanol shall be added for dissolution, then dilute to scale with mobile phase, shake, filter, take the filtrate, as a test solution, according to the method under the item of cefpodoxime proxetil, obtained.
Same as cefpodoxime proxetil.
Based on C15H17N506S2 (l)50mg (2)100Mg
sealed and stored in a cool and dry place.