Molecular Formula | C16H18N3NaO7S2 |
Molar Mass | 451.44 |
Melting Point | >160°C |
Boling Point | 843℃ |
Specific Rotation(α) | 25589nm +210° (c = 1 in methanol) |
Flash Point | >110°(230°F) |
Water Solubility | Soluble in water or methanol |
Solubility | Soluble in water, DMSO, and methanol. |
Vapor Presure | 3.24E-30mmHg at 25°C |
Appearance | neat |
Color | White |
Storage Condition | 2-8°C |
MDL | MFCD00079042 |
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 - Wear suitable protective clothing and gloves. S36/37/39 - Wear suitable protective clothing, gloves and eye/face protection. |
UN IDs | 3077 |
WGK Germany | 3 |
RTECS | XI0330500 |
HS Code | 29419000 |
Hazard Class | 9 |
Packing Group | III |
Toxicity | LD50 in mice, rats, dogs (g/kg): 5.10, 8.98, >10.0 i.v. (Takayama) |
This product is (6R,7R)-3-(carbamoyloxymethyl) -7-methoxy-ioxo-7-[2-(2-thienyl)] acetylamino]-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylic acid sodium salt. According to the anhydrous and solvent-free calculation, containing cefoxitin (C16H17N307S2) shall not be less than 90.5%.
take this product, precision weighing, add methanol 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 should be between +206 ° and +214 °.
take this product, precision weighing, adding water to dissolve and quantitatively dilute to make a solution containing about lmg per lml, take 2ml for precision measurement, and put it in a 100ml measuring flask, dilute with 4.2% sodium bicarbonate solution to the scale, shake, according to UV-visible spectrophotometry (General 0401), at the wavelength of absorbance measurement, absorption coefficient is 190~210.
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 4.2~7.0.
take 5 parts of this product, each 0.55g, respectively, after adding water 5ml to dissolve, the solution should be clear and colorless; If it is turbid, compare with No. 1 turbidity standard solution (General rule 0902 first method), shall not be more concentrated; If the color is developed, it shall not be deeper in comparison with the yellow or yellow-green standard colorimetric solution No. 8 (General rule 0901 method 1).
take about 50mg of this product, weigh it accurately, put it in a 10ml measuring flask, add phosphate buffer solution (weigh 34.836g of Dipotassium hydrogen phosphate, add 6.8 of water to dissolve, and adjust the pH value to with phosphoric acid, take 20ml, dilute with water to 1000ml), dissolve and dilute to the scale, shake, filter, as a test solution; Take 1.0ml of the test solution, put it in a 100ml measuring flask, as a control solution, it was diluted to the scale with the above phosphate buffer and shaken. As determined by HPLC (General 0512), phenyl-bonded silica gel was used as filler; Mobile phase A was water (adjusted to pH 2.7 with formic acid), and mobile phase B was acetonitrile, the linear gradient elution was carried out as follows; The detection wavelength was 235Nm. Take an appropriate amount of cefoxitin reference substance, dissolve and dilute it with the above phosphate buffer solution to make a solution containing about 0.25mg per 1 ml, place it at 70°C for 1 hour, let it cool, inject it into the liquid chromatograph, record the chromatogram, the retention time of cefoxitin peak is about 35 minutes, and the separation degree between cefoxitin peak and impurity peak whose relative retention time is about 0.8 should be greater than 5.0. The test solution and the control solution are accurately sampled at 20 u1 respectively, and human liquid chromatograph is injected respectively, and the chromatogram is recorded. If there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be greater than 0.5 times (0.5%) of the area of the main peak of the control solution, the Peak area of each impurity shall not be greater than 4 times (4.0%) of the main peak area of the control solution, and the peak in the chromatogram of the test solution which is smaller than 0.05 times of the main peak area of the control solution is ignored.
take this product about 1.Og, precision weighing, 10ml measuring flask, plus internal standard solution (take an appropriate amount of methyl ethyl ketone, diluted with water to make a solution containing about 200ug per 1 ml) dissolve and dilute to the scale, shake, as the test solution (1), take the sample solution (1)1.0ml and the internal standard solution 1.0mL in the same headspace bottle, sealed as a test solution. Accurately weigh appropriate amount of each solvent reference substance respectively, and quantitatively dilute with internal standard solution to make methanol 0.3mg, ethanol 0.5mg, acetonitrile 41ug, acetone 0.5mg, the solution of ethyl acetate (0.5mg) and tetrahydrofuran (72ug) is used as the mixed reference solution. The mixed reference solution (1.0ml) and the sample solution (1) (1.0ml) are accurately weighed and placed in the same headspace bottle and sealed, as a control solution. According to the determination method of residual solvent (General Principle 0861 first method), the capillary column with 100% dimethyl polysiloxane (or similar polarity) as stationary liquid is used as the column, The column temperature was 40°C, the inlet temperature was 200°C, the detector temperature was 250°C, the headspace bottle equilibrium temperature was 70°C, and the equilibrium time was 30 minutes. The reference solution was injected in Headspace, and the peaks were generated in the order of methanol, ethanol, acetonitrile, acetone, butanone (internal standard), ethyl acetate and tetrahydrofuran, the degree of separation between peaks shall meet the requirements. The test solution and the reference solution were injected into the headspace, and the chromatogram was recorded. The peak area was calculated by the standard addition method, methanol, ethanol, acetonitrile, acetone, the residues of ethyl acetate and tetrahydrofuran shall be in accordance with the regulations.
take this product, according to the determination of moisture (General rule 0832 first method 1), with ethylene glycol-pyridine (3:1) as the solvent, containing no more than 1.0% of water.
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 2g, plus particle inspection water dissolution, inspection according to law (General 0904), should comply with the provisions. (For aseptic dispensing)
Take 3 parts of this product, and make a solution containing 50mg per 1 ml with water for particle inspection, and check it according to law (General rule 0903), no more than 6000 particles of 10um and lOum in each lg sample, and no more than 600 particles of 25um and 25um in each sample. (For aseptic dispensing)
take this product, check according to law (General rule 1143), each 1 mg of cefoxitin containing endotoxin amount 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 eighteen alkyl silane was used as a filler; Water-acetonitrile-glacial acetic acid (81:19:1) was used as a mobile phase; The detection wavelength was 254mn. The appropriate amount of cefoxitin reference substance was accurately weighed, and phosphate buffer solution (potassium dihydrogen phosphate l) was added. Og and disodium hydrogen phosphate 1.8G, add water 900ml to dissolve, adjust the pH value to 7.1±0.1 with phosphoric acid or lOmol/L sodium hydroxide solution, dilute to 1000ml with water) dissolve and dilute to make a solution containing about 0.3mg per lml. Accurately measure and inject lol into human liquid chromatograph, record chromatogram, and the tailing factor of cefoxitin peak should not be more than 1.8, the separation degree between cefoxitin peak and adjacent impurity peak should meet the requirements.
take this product, precision weighing, add the above phosphate buffer solution and quantitative dilution to prepare a solution containing about 0.3mg of cefoxitin per 1 ml, as a test solution, A 10ul injection liquid chromatograph was used to record the chromatogram. An appropriate amount of cefoxitin reference was taken and determined by the same method. According to the external standard method, the content of C16H17N307S2 in the sample was calculated by peak area.
B-lactam antibiotics, cephalosporins.
sealed and stored in a cool dark dry place.
This product is a sterile powder of cefoxitin sodium. Calculated as anhydrous, containing cefoxitin (Cl6H17N307S2) shall not be less than 89.5%; Calculated as the average loading, containing cefoxitin (Cl6H17N307S2) shall be 90.0% ~ 110.0% of the label amount.
This product is white or off-white powder with strong hygroscopicity.
take this product, according to cefoxitin sodium under the identification test, showed the same results.
The content under the item of loading amount difference was obtained by measuring according to the method of cefoxitin sodium under the item.
with cefoxitin sodium.
1.0g (2)2.0g by Cl6H17N307S2
sealed and stored in a cool dark dry place.