5-Thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic acid, 7-((((cyanomethyl)thio)acetyl)amino)-7-methoxy-3-(((1-methyl-1H-tetrazol-5-yl)thio)methyl)-8-oxo-, sodium salt, (6R-cis)-
Cefmetazole Sodium
CAS: 56796-39-5
Molecular Formula: C15H16N7O5S3.Na
5-Thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic acid, 7-((((cyanomethyl)thio)acetyl)amino)-7-methoxy-3-(((1-methyl-1H-tetrazol-5-yl)thio)methyl)-8-oxo-, sodium salt, (6R-cis)- - Names and Identifiers
5-Thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic acid, 7-((((cyanomethyl)thio)acetyl)amino)-7-methoxy-3-(((1-methyl-1H-tetrazol-5-yl)thio)methyl)-8-oxo-, sodium salt, (6R-cis)- - Physico-chemical Properties
| Molecular Formula | C15H16N7O5S3.Na |
| Molar Mass | 493.52 |
| Melting Point | >130°C (dec.) |
| Water Solubility | Soluble in water |
| Solubility | H2O: soluble50mg/mL |
| Appearance | powder |
| Color | White to Off-White |
| Merck | 14,1926 |
| Storage Condition | Inert atmosphere,2-8°C |
| Sensitive | Hygroscopic |
5-Thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic acid, 7-((((cyanomethyl)thio)acetyl)amino)-7-methoxy-3-(((1-methyl-1H-tetrazol-5-yl)thio)methyl)-8-oxo-, sodium salt, (6R-cis)- - Risk and Safety
| Risk Codes | R36/37/38 - Irritating to eyes, respiratory system and skin. R42/43 - May cause sensitization by inhalation and skin contact. |
| Safety Description | S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S36 - Wear suitable protective clothing. |
| WGK Germany | 2 |
| RTECS | XI0372200 |
| Toxicity | LD50 i.v. in rats: >5000 mg/kg (Masuda) |
5-Thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic acid, 7-((((cyanomethyl)thio)acetyl)amino)-7-methoxy-3-(((1-methyl-1H-tetrazol-5-yl)thio)methyl)-8-oxo-, sodium salt, (6R-cis)- - Standard
Authoritative Data Verified Data
(6R,7s)-7-[2-[ (cyanomethyl)] thio] acetamido] -7-methoxy-3-[(l-methyl -1H-tetrazol-5-yl) thioyl] methyl]-8-oxo-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylic acid sodium salt. Containing not less than 86.0% cefmetazole (C15H17N7O5S3), calculated as anhydrous.
Last Update：2024-01-02 23:10:35
5-Thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic acid, 7-((((cyanomethyl)thio)acetyl)amino)-7-methoxy-3-(((1-methyl-1H-tetrazol-5-yl)thio)methyl)-8-oxo-, sodium salt, (6R-cis)- - Trait
Authoritative Data Verified Data
- This product is white to yellowish powder; Highly hygroscopic.
- This product is very soluble in water, soluble in methanol, slightly soluble in acetone, slightly soluble in ethanol, almost insoluble in ether or methylene chloride.
specific rotation
take this product, precision weighing, adding water to dissolve and quantitatively dilute to make a solution containing about 10 mg per lml, and determine according to law (General rule 0621). The specific rotation is 73 ° to 85 °.
absorption coefficient
take this product, precision weighing, add water to dissolve and quantitatively dilute to make a solution containing about 25ug per lml, according to UV-visible spectrophotometry (General 0401), the absorbance was measured at a wavelength of 272nm, and the absorption coefficient was 200-230.
Last Update：2022-01-01 11:40:59
5-Thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic acid, 7-((((cyanomethyl)thio)acetyl)amino)-7-methoxy-3-(((1-methyl-1H-tetrazol-5-yl)thio)methyl)-8-oxo-, sodium salt, (6R-cis)- - Preparation solution concentration reference
| 1mg | 5mg | 10mg | |
|---|---|---|---|
| 1 mM | 2.026 ml | 10.131 ml | 20.263 ml |
| 5 mM | 0.405 ml | 2.026 ml | 4.053 ml |
| 10 mM | 0.203 ml | 1.013 ml | 2.026 ml |
| 5 mM | 0.041 ml | 0.203 ml | 0.405 ml |
Last Update：2024-01-02 23:10:35
5-Thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic acid, 7-((((cyanomethyl)thio)acetyl)amino)-7-methoxy-3-(((1-methyl-1H-tetrazol-5-yl)thio)methyl)-8-oxo-, sodium salt, (6R-cis)- - Differential diagnosis
Authoritative Data Verified Data
- in the chromatogram recorded under the content determination item, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the reference solution.
- take an appropriate amount of this product, add water to dissolve and dilute to make a solution containing about 25ug per lml, and measure it by UV-Vis spectrophotometry (General rule 0401), there is a maximum absorption at a wavelength of 272nm.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 1125).
- This product shows the reaction of sodium salt identification (1) (General rule 0301).
Last Update：2022-01-01 11:41:00
5-Thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic acid, 7-((((cyanomethyl)thio)acetyl)amino)-7-methoxy-3-(((1-methyl-1H-tetrazol-5-yl)thio)methyl)-8-oxo-, sodium salt, (6R-cis)- - Exam
Authoritative Data Verified Data
acidity
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 4.2~6.2.
clarity and color of solution
take 5 parts of this product, 0.55g each, add 5ml of water to dissolve, immediately check according to law, the solution should be clear and colorless; If it is turbid, no one shall be more concentrated than the turbidity standard liquid No. 1 (General rule 0902 method 1), and no one shall be deeper than the yellow or yellow-green standard colorimetric liquid No. 4 (general rule 0901 method 1) in case of color development.
Related substances
take the right amount of this product, precision weighing, add water to dissolve and quantitatively dilute the solution containing about 1 mg of cefmetazole in each lml, as a test solution (new system); take 1 ml accurately, put it in a 100ml measuring flask, dilute it to the scale with water, shake it well, and use it as a control solution. Take an appropriate amount of 1-methyl-5-mercaptotetrazolium reference substance by precision weighing, water was added for dissolution and quantitative dilution to make about O per 1 ml. Olmg solution, as an impurity control solution. 5ml of the control solution was accurately measured, placed in a 100ml measuring flask, diluted to the scale with mobile phase, and shaken to serve as a sensitivity solution. According to the chromatographic condition test under the content determination item, the sensitivity solution 20u1 is injected into the liquid chromatograph, and the signal-to-noise ratio of the main component peak height should be greater than 10. 20ul of the test solution, the control solution and the impurity reference solution were respectively injected into the human liquid chromatograph, and the chromatogram was recorded to 3 times of the retention time of the main component peak. If there are chromatographic peaks in the chromatogram of the test solution that are consistent with the retention time of 1-methyl-5-mercaptotetrazole, the peak area shall be calculated according to the external standard method, and shall not exceed 1.0%; other maximum single impurity peak area shall not be greater than 2 times (2.0%) of the main peak area of the control solution, and other single impurity peak area shall not be greater than 0.5 times (0.5%) of the main peak area of the control solution, the sum of the peak areas of other impurities shall not be greater than 3.5 times (3.5%) of the main peak area of the control solution. The peaks in the chromatogram of the test solution which are smaller than the main peak area of the sensitivity solution are ignored.
cefmetazole polymer
measured by size exclusion chromatography (General 0514).
chromatographic conditions and system suitability test
Sephadex gel G-10(40 to um) was used as a filler, and the inner diameter of the glass column was 1.0 to 1.4 and the length of the column was 30 to 40. Mobile phase A was 0 at pH 8.0. lmol/L phosphate buffer [0.1 mol/L disodium hydrogen phosphate solution -0.1 mol/L sodium dihydrogen phosphate solution (95:5)], mobile phase B is water, the flow rate is about 0.8 per minute, the detection wavelength is 254nm. Take 0. LMG/ml Blue dextran 2000 solution 100~200 u1, inject human liquid chromatograph, respectively with mobile phase A, B as mobile phase test, record chromatogram, the number of theoretical plates is not less than 2000 calculated by the Blue dextran 400 peak, and the tailing factor should be less than 2.0. In the two mobile phase system, the ratio of the retention time of the Blue dextran 2000 peak should be between 0.93 and 1.07, the ratio of the retention time of the main peak of the control solution and the polymer peak in the test solution to the Blue dextran 2000 peak in the corresponding chromatography system should be between 0.93 and 1.07. Take about 2000g of cefmetazole sodium, put it in a 100 measuring flask, add mg/ml of Blue dextran solution to dissolve and dilute to the scale, shake well, and inject ~ 200ul into human liquid chromatograph, the mobile phase A was used for measurement, and the chromatogram was recorded. The ratio of the peak height of the polymer to the valley height between the monomer and the polymer should be greater than 2.0. In addition, the mobile phase B is used as the mobile phase, and 100-200ul of the control solution is accurately measured, and the sample is continuously injected for 5 times. The relative standard deviation of the peak area should not be more than 5.0%.
preparation of control solution
an appropriate amount of cefmetazole control was accurately weighed, dissolved with water and quantitatively diluted to prepare a solution containing about lO0ug per 1 ml.
assay
take about 0.2g of this product, accurately weigh it, put it in a 10ml measuring flask, add water to dissolve and dilute to the scale, shake well, immediately inject 100 ~ 200ul into the liquid chromatograph, the mobile phase A was used as the mobile phase, and the chromatogram was recorded. In addition, 100 to 200u1 of the control solution was injected into the liquid chromatograph, and the mobile phase B was used as the mobile phase, which was measured by the same method. The amount of polymer containing cefmetazole shall not exceed 0.1% calculated by the area of cefmetazole peak according to the external standard method.
residual solvent
take about 0.2g of this product, precision weighing, set in the top empty bottle, Precision Add internal standard solution (take the right amount of N-propanol, water made in each 1 mL solution containing about 50ug) 2ml dissolved, sealed, as a test solution; Precision weighing methanol, acetone, isopropanol, dichloromethane, ethyl acetate, methyl isobutyl ketone, diluted with internal standard solution to prepare a mixed solution containing about 0.3mg of methanol, 0.5mg of acetone, 0.5mg of isopropanol, 60ug of dichloromethane, 0.5mg of ethyl acetate and 0.5mg of methyl isobutyl ketone per 1 ml, 2ml was accurately measured, placed in a top empty bottle, sealed, and used as a reference solution. Determined according to the residual solvent assay (General 0861 second method). The capillary column with 6% cyanopropylphenyl-94% polydimethylsiloxane (or similar polarity) as stationary liquid is used as the chromatographic column, and the initial temperature is 40°C, and the maintenance time is 5 minutes, then the temperature is increased to 200°C at a rate of 20°C per minute for 5 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 60°C, the equilibration time was 30 minutes. Take the reference solution into the headspace, according to methanol, acetone, isopropanol, dichloromethane, ethyl acetate, methyl isobutyl ketone peaks in sequence, the separation degree between the peaks should meet the requirements. The test solution and the reference solution were injected into the headspace respectively, and the chromatogram was recorded and calculated by the peak area ratio according to the internal standard method. Methanol, acetone, isopropanol, dichloromethane, ethyl acetate and methyl isobutyl ketone residues shall be in accordance with the provisions.
moisture
take this product, according to the moisture determination method (General 0832 first method 1), the water content shall not exceed 1.0%.
Heavy metals
This product l.Og, inspection according to law (General Principles 0821 second law), containing heavy metals shall not exceed 20 parts per million.
visible foreign body
take 5 parts of this product, each 2.0g, plus particle inspection water to make a solution containing about 0.lg per lml, according to law inspection (General 0904), should comply with the provisions. (For aseptic dispensing)
insoluble particles
Take 3 parts of this product, Add particle inspection water to dissolve and make a solution containing about 50mg per 1 ml, and check according to law (General rule 0903), no more than 6000 particles with lOum and more than 10um and no more than 600 particles with more than 25um per lg of sample. (For aseptic dispensing)
bacterial endotoxin
take this product, check according to law (General rule 1143), the amount of endotoxin per 1 mg cefmetazole should be less than 0.050EU. (For injection)
sterile
take this product, add 0.9% sterile sodium chloride solution to dissolve and dilute to prepare a solution containing about G cefmetazole per 1 ml, and treat it by membrane filtration, with pH7.0 sterile gasification sodium-peptone buffer washing (not less than 600ml per membrane), with Staphylococcus aureus as positive control bacteria, according to the law (General Principles 1101), should comply with the provisions. (For aseptic dispensing)
Last Update：2022-01-01 11:41:01
5-Thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic acid, 7-((((cyanomethyl)thio)acetyl)amino)-7-methoxy-3-(((1-methyl-1H-tetrazol-5-yl)thio)methyl)-8-oxo-, sodium salt, (6R-cis)- - Content determination
Authoritative Data Verified Data
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
silica gel was bonded with OCTA alkyl silane as filler; Ammonium dihydrogen phosphate solution (take 5.75g of ammonium dihydrogen phosphate, add ml of water to dissolve, add 10% tetrabutylammonium hydroxide 19.2-tetrahydrofuran-methanol (730:12.5:300)(with phosphoric acid to adjust the pH value to 4.5) as the mobile phase; Column temperature is 35 deg C; Flow rate is 1.0ml per minute; The detection wavelength is 254mn. Take about 25mg of this product, put it in a 25ml measuring flask, add 1ml of 6% hydrogen peroxide solution, place it for 5 minutes, add 20ml of water, add 1ml of a solution containing 0.5mg of 1-methyl-5-mercaptotetrazolium impurity control substance per 1ml, dilute with water to the scale, shake well, and use as a system applicable solution, immediately take 20u1 injection human liquid chromatograph, record chromatogram, 1-methyl -5-mercaptotetrazole peak and its adjacent impurity peak separation degree should meet the requirements, the separation degree between the cefmetazole peak and the adjacent impurity peak should meet the requirements.
assay
take an appropriate amount of this product (about 50mg equivalent to cefmetazole), accurately weigh it, put it in a 50ml measuring flask, add water to dissolve and dilute to the scale, shake well; Take 5ml for precise measurement, put it in a 50ml measuring flask, dilute it to scale with water, shake it well, and use it as a test solution. Use 20ul injection liquid chromatograph to record the chromatogram, in the same operation method, the content of C15H17N7O5S3 in the test article is calculated by the peak area according to the external standard method.
Last Update：2022-01-01 11:41:04
5-Thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic acid, 7-((((cyanomethyl)thio)acetyl)amino)-7-methoxy-3-(((1-methyl-1H-tetrazol-5-yl)thio)methyl)-8-oxo-, sodium salt, (6R-cis)- - Category
Authoritative Data Verified Data
B-tablets of lactam antibiotics, cephalosporins.
Last Update：2022-01-01 11:41:07
5-Thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic acid, 7-((((cyanomethyl)thio)acetyl)amino)-7-methoxy-3-(((1-methyl-1H-tetrazol-5-yl)thio)methyl)-8-oxo-, sodium salt, (6R-cis)- - Storage
Authoritative Data Verified Data
sealed and stored in a cool dark dry place.
Last Update：2022-01-01 11:41:09
5-Thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic acid, 7-((((cyanomethyl)thio)acetyl)amino)-7-methoxy-3-(((1-methyl-1H-tetrazol-5-yl)thio)methyl)-8-oxo-, sodium salt, (6R-cis)- - Cefmetazole sodium for injection
Authoritative Data Verified Data
This product is a sterile powder of cefmetazole sodium. The content of cefmetazole (C15H17N7O5S3) shall not be less than 86.0%, calculated as anhydrous; The content of cefmetazole (C15H17N7O5S3) shall be 90.0% to 110.0% of the labeled amount, calculated as average loading.
trait
This product is white to yellowish powder.
identification
According to the identification test under the item of cefmetazole sodium, the same result was shown.
examination
- the clarity and color of the solution take 5 bottles of this product, according to the label amount of water dissolved and made in each lml containing 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. 6 (General rule 0901, Method 1).
- insoluble particles take this product, according to the label, respectively, plus particles to check the dissolution of water and make a solution containing about 50mg per 1 ml, according to the law (General 0903), the label amount is l. The conversion below Og is per l. No more than 6000 particles with 10um and more than lOum in Og sample, no more than 600 particles with 25um and more; The labeled amount is more than 1.0g (including g). No more than 6000 particles of 10um or more and no more than 600 particles of 25um or more should be contained in each sample container.
- the acidity, related substances, cefmetazole polymer, moisture, cell endotoxin and sterility should be checked according to the method of cefmetazole sodium.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
The content under the item of loading amount difference was taken and measured according to the method of cefmetazole sodium.
category
Same as cefmetazole sodium.
specification
According to C15H17N7O5S3 (1)0.25g (2)0.5g(3)1.0g (4) 2.og
storage
sealed and stored in a cool dark dry place.
Last Update：2022-01-01 11:41:11
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Spot supply
Product Name: Cefmetazole Sodium Visit Supplier Webpage Request for quotationCAS: 56796-39-5
Tel: 0714-3999186
Email: 2853786052@qq.com
Mobile: 86+15671228036
QQ: 2853786052
Wechat: 15671228036
Spot supply
Product Name: Cefmetazole sodium Visit Supplier Webpage Request for quotationCAS: 56796-39-5
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409
Wechat: 18301782025
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