7-[[(2-Amino-4-thiazolyl)(methoxyimino)acetyl]amino]-3-[[(1-methyl-1H-tetrazol-5-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid hemihydrochloride
cefmenoxime hydrochloride
CAS: 75738-58-8
Molecular Formula: C32H35ClN18O10S6
7-[[(2-Amino-4-thiazolyl)(methoxyimino)acetyl]amino]-3-[[(1-methyl-1H-tetrazol-5-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid hemihydrochloride - Names and Identifiers
| Name | cefmenoxime hydrochloride |
| Synonyms | Tacef Cemix Bestron Bestcall SCE-1365(free acid) Cefmenoxime.1.5 HCl CefmenoximeHydrochloride cefmenoxime hydrochloride 7beta-[2-(2-Aminothiazol-4-yl)-(Z)-2-(methoxyiminoacetamido)]-3-[(1-methyl-1H-tetrazol-5-yl)thiomethyl]ceph-3-em-4-carboxylic acid hemihydrochloride 7-[[(2-Amino-4-thiazolyl)(methoxyimino)acetyl]amino]-3-[[(1-methyl-1H-tetrazol-5-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid hemihydrochloride 7-[[(2-Amino-4-thiazolyl)(methoxyimino)acetyl]amino]-3-[[(1-methyl-1H-tetrazol-5-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid hemihydrochloride |
| CAS | 75738-58-8 |
| EINECS | 278-299-4 |
| InChI | InChI=1/2C16H17N9O5S3.ClH/c2*1-24-16(20-22-23-24)33-4-6-3-31-13-9(12(27)25(13)10(6)14(28)29)19-11(26)8(21-30-2)7-5-32-15(17)18-7;/h2*5,9,13H,3-4H2,1-2H3,(H2,17,18)(H,19,26)(H,28,29);1H/b2*21-8-;/t2*9-,13-;/m11./s1 |
7-[[(2-Amino-4-thiazolyl)(methoxyimino)acetyl]amino]-3-[[(1-methyl-1H-tetrazol-5-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid hemihydrochloride - Physico-chemical Properties
| Molecular Formula | C32H35ClN18O10S6 |
| Molar Mass | 1059.58 |
| Melting Point | >175°C (dec.) |
| Solubility | DMSO (Slightly, Heated), Methanol (Slightly) |
| Appearance | Solid |
| Color | Off-White to Pale Yellow |
| Storage Condition | under inert gas (nitrogen or Argon) at 2-8°C |
7-[[(2-Amino-4-thiazolyl)(methoxyimino)acetyl]amino]-3-[[(1-methyl-1H-tetrazol-5-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid hemihydrochloride - Risk and Safety
| HS Code | 2941906000 |
7-[[(2-Amino-4-thiazolyl)(methoxyimino)acetyl]amino]-3-[[(1-methyl-1H-tetrazol-5-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid hemihydrochloride - Standard
Authoritative Data Verified Data
(6R,7R)-7-[(Z)-2-(2-amino-4-thiazolyl)-2-methoxyiminoacetamido]-3-[[(l-methyl -1H-tetrazol-5-yl) thioyl] methyl]-8-oxo-5-thia-1-azabicyclo [4. 2. O] oct-2-ene-2-carboxylic acid hydrochloride (2:1). Containing no less than 89.0% cefmenoxime (Cl6H17N905S3), calculated as anhydrous.
Last Update：2024-01-02 23:10:35
7-[[(2-Amino-4-thiazolyl)(methoxyimino)acetyl]amino]-3-[[(1-methyl-1H-tetrazol-5-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid hemihydrochloride - Trait
Authoritative Data Verified Data
- This product is white to light yellow crystal or crystalline powder; There is hygroscopicity.
- This product is soluble in formamide, slightly soluble in methanol, slightly soluble in water, insoluble in ethanol; In PH 6.8 phosphate buffer (potassium dihydrogen phosphate 6.4G and sodium dihydrogen phosphate 18.9g), water 750mr was added to dissolve, and the pH value was adjusted to 6.8±0.1 with 1 mol /L sodium hydroxide solution.
specific rotation
take this product, precision weighing, add the above pH 6.8 phosphate buffer solution and quantitative dilution to make the solution containing about 10 mg per 1 ml, according to the law (General 0621), the specific rotation is from one 27 ° to one 35 °.
absorption coefficient
take this product, precision weighing, add the above pH 6.8 phosphate buffer solution and quantitative dilution to make a solution containing about 15ug per 1 ml, the absorption coefficient measured at a wavelength of 257nm according to ultraviolet-visible spectrophotometry (General rule 0401) is 335 to 360.
Last Update：2022-01-01 14:21:55
7-[[(2-Amino-4-thiazolyl)(methoxyimino)acetyl]amino]-3-[[(1-methyl-1H-tetrazol-5-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid hemihydrochloride - Preparation solution concentration reference
| 1mg | 5mg | 10mg | |
|---|---|---|---|
| 1 mM | 1.888 ml | 9.438 ml | 18.875 ml |
| 5 mM | 0.378 ml | 1.888 ml | 3.775 ml |
| 10 mM | 0.189 ml | 0.944 ml | 1.888 ml |
| 5 mM | 0.038 ml | 0.189 ml | 0.378 ml |
Last Update：2024-01-02 23:10:35
7-[[(2-Amino-4-thiazolyl)(methoxyimino)acetyl]amino]-3-[[(1-methyl-1H-tetrazol-5-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid hemihydrochloride - 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.
- The infrared absorption spectrum of this product should be consistent with that of the reference product (General rule 0402).
- Take 10mg of this product, add 1 ml of 0.5% sodium carbonate solution to dissolve, add 5ml of glacial acetic acid and 2 drops of silver nitrate test solution to form white precipitate.
Last Update：2022-01-01 14:21:55
7-[[(2-Amino-4-thiazolyl)(methoxyimino)acetyl]amino]-3-[[(1-methyl-1H-tetrazol-5-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid hemihydrochloride - Exam
Authoritative Data Verified Data
acidity
take this product, add water to make a suspension containing about 10 mg per lml, and determine it according to law (General 0631). The pH value should be 2.5~4.0.
clarity and color of solution
take 5 parts of this product, 0.55g each, add 2% sodium carbonate solution 5ml to dissolve, 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. 7 (general rule 0901 method 1) in case of color development.
Related substances
new system for clinical use. Take about 20mg of this product, precision weighing, add the above pH 6.8 phosphate buffer solution 4ml to dissolve, diluted with mobile phase A to make A solution containing about 0.2mg per 1 ml, as A test solution; the appropriate amount of the test solution was accurately taken, and the solution containing about 2ug per 1 ml was prepared by quantitative dilution with mobile phase A as the control solution; accurately weigh an appropriate amount of 1-methyl-5-mercaptotetrazole reference substance, add mobile phase A to dissolve and quantitatively dilute to prepare A solution containing about 2ug per 1 ml, as a 1-methyl-5-mercaptotetrazole control solution. According to the determination of high performance liquid chromatography (General rule 0512), with eighteen alkyl silane bonded silica gel as filler (4.6mm x mm,5um or performance equivalent column); mobile phase A was water-glacial acetic acid-acetonitrile (85:1.7:15), and mobile phase B was water-glacial acetic acid-acetonitrile (50:1.7:50); the detection wavelength was 254mn. 10mg of cefmenoxime was added with 0.5ml of 1 mol/ L sodium hydroxide solution, and the mixture was placed for 30 minutes, neutralized with 6.8 ml of 1 mol/ L hydrochloric acid solution, and dissolved with 2ml of the above-mentioned pH phosphate buffer solution, dilute with mobile phase A to make A solution containing about 0.2mg per 1 ml, inject 20ul into the liquid chromatograph, and record the chromatogram. The retention time of cefmenoxime peak is about 10 minutes, the resolution between cefmenoxime peak and adjacent decomposition product peak (relative retention time about 0.77) should be greater than 4.5. About 20mg of cefmenoxime control was dissolved by adding 4ml of the above pH 6.8 phosphate buffer solution, and diluted with 1-methyl-5-mercaptotetrazolium control solution to prepare a solution containing about mg of cefmenoxime per 1 ml, 20u1 was injected into the liquid chromatograph, and the chromatogram was recorded. The resolution between cefmenoxime peak and 1-methyl-5-mercaptotetrazolium peak should be greater than 12.0. The sample solution, 1-methyl-5-mercaptotetrazolium reference solution and control solution were respectively injected with 2u1, and the chromatogram was recorded. If there are impurity peaks in the chromatogram of the test solution, the content of 1-methyl-5-mercaptotetrazole shall be calculated by the peak area according to the external standard method, and shall not exceed 1.0%; other single impurity peak area shall not be greater than the main peak area of the control solution (1.0%), and the sum of each impurity peak area shall not be greater than 3 times (3.0%) of the main peak area of the control solution. The peaks in the chromatogram of the test solution which were 0.1 times smaller than the main peak area of the control solution were ignored.
cefmenoxime
polymers were determined by size exclusion chromatography (General 0514).
chromatographic conditions and system suitability test
A glass column having an inner diameter of 1.0 to 1.4 and a column length of 30 to G-10 was filled with dextran gel (40 to um). At pH 7.0 0.lmol/L phosphate buffer [0.1 mol/L disodium hydrogen phosphate solution-O. 1 mol/L sodium dihydrogen phosphate solution (61:39)] as mobile phase A, water as mobile Phase B, the flow rate was about 1.0ml per minute, the detection wavelength was 254nm. Take 0.2~2000 u1 of 100 mg/m l Blue dextran 200 solution and inject it into human liquid chromatograph, using mobile phase A and B as mobile phase respectively, record chromatogram, the number of theoretical plates is not less than 2000 calculated by the Blue dextran 700 peak, and the tailing factor should be less than 2.0. In both mobile phase systems, the retention time ratio 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. About 0.2g of cefmenoxime hydrochloride and 40mg of anhydrous sodium carbonate were placed in a 10ml measuring flask, and 0.2mg/ml of Blue dextran 2000 solution was added to dissolve and dilute to the scale, and shake well. 100~200u1 was injected into the liquid chromatograph, and the measurement was performed with the mobile phase A, 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 1.5. In addition, the mobile phase B is used as the mobile phase, and the relative standard deviation of the peak area should not be more than 100 when the control solution is 200-5.0% u1 for 5 consecutive injections.
preparation of control solution
about 21mg of cefmenoxime reference substance was accurately weighed and placed in a 500ml measuring flask, and 5m l of pH 7.0 phosphate buffer solution was added to dissolve the solution. The solution was diluted with water to scale and shaken.
assay
take about 0.2g of this product and anhydrous sodium carbonate 50mg, precision weighing, put 10ml measuring flask, add water to dissolve and dilute to the scale, shake. Immediately inject 100~200u1 into human liquid chromatograph, use mobile phase A as mobile phase for measurement, and record chromatogram. In addition, 100~200u1 of the control solution was injected into the human liquid chromatograph, and the mobile phase B was used as the mobile phase, and the same method was used for measurement. The amount of cefmenoxime polymer shall not exceed 0.5% calculated by the peak area of cefmenoxime according to the external standard method.
residual solvent
take this product about O.lg, precision weighing, in the top empty bottle, precision add N,N-dimethylformamide 2ml to dissolve, sealed, as a test solution; Take Tetrahydrofuran, dichloromethane, the appropriate amount of ethyl acetate and ethanol are precisely weighed and quantitatively diluted with N,N-dimethylformamide to prepare mixed solutions containing about 0.036mg, 0.03mg, 0.25mg and 0.25mg respectively per 1 ml, 2.0 was accurately measured, placed in a top empty bottle, sealed, and used as a reference solution. According to the determination method of residual solvent (General Principle 0861 second method), the capillary column with 6% cyanopropyl phenyl-94% dimethyl polysiloxane (or similar polar) as stationary liquid is used as the column, and the initial temperature is 60°C, it was maintained for 10 minutes and then increased to 180°C at a rate of 20°C per minute for 2 minutes; The detector temperature was 250°C; The inlet temperature was 200°C. The Headspace bottle equilibration temperature was 80°C and the equilibration time was 30 minutes. Take the reference solution into the headspace, 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 the peak area was calculated according to the external standard method. Tetrahydrofuran, dichloromethane, ethyl acetate and ethanol 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 1.5%.
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 of which is 2.0g, and add 0.5% sodium carbonate solution (filtered by 0.45um filter) to dissolve. Check according to law (General rule 0904) should comply with the regulations. (For aseptic dispensing)
insoluble particles
take this product, add 0.5% sodium carbonate solution (filtered through 0.45pm filter) to dissolve and dilute to make a solution containing about 20mg per 1 ml, and check according to law (General rule 0903), no more than 6000 particles with lOum or more and no more than 600 particles with 25um and 25um in each lg sample. (For aseptic dispensing)
bacterial endotoxin
take this product and add sodium carbonate solution (weigh 170g of sodium carbonate heated at 2.0°C for more than 4 hours, dissolve with water for injection and dilute to 100ml) dissolve and dilute the solution containing about 80mg of cefmenoxime per 1 ml, and check according to law (General rule 1143). The amount of endotoxin in cefmenoxime per 1 mg should be less than EU. (For injection)
sterile
take this product, add 2% sterile sodium carbonate solution to dissolve and dilute the solution containing 10 mg per 1 ml, and treat it by membrane filtration, with pH 7.0 sterile sodium chloride-peptone buffer washing (not less than 1101 per membrane), with Escherichia coli as positive control bacteria, according to the law (General Principles), should comply with the provisions. (For aseptic dispensing)
Last Update：2022-01-01 14:21:57
7-[[(2-Amino-4-thiazolyl)(methoxyimino)acetyl]amino]-3-[[(1-methyl-1H-tetrazol-5-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid hemihydrochloride - Content determination
Authoritative Data Verified Data
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
silica gel bonded with eighteen alkyl silane was used as filler; Water-glacial acetic acid-acetonitrile (85:1.7:15) was used as mobile phase; The detection wavelength was 254nm. Take 10mg of ceftazidime reference, add 0.5ml of lmol /L sodium hydroxide solution, place for 30 minutes, add 0.5ml of lmol /L hydrochloric acid solution and add 2ml of pH6.8 phosphate buffer solution to dissolve, dilute with mobile phase to prepare a solution containing about 40ug per lml, take 20u1 and inject it into human liquid chromatograph, record the chromatogram, and the retention time of cefmenoxime peak is about 10 minutes, the resolution between cefmenoxime peak and adjacent decomposition product peak (relative retention time about 0.77) should be greater than 4.5.
assay
take about 20mg of this product, precision weighing, add the above pH 6.8 phosphate buffer 4ml to dissolve, quantitatively dilute with mobile phase to make a solution containing about 40ug per 1 ml, as a test solution, the precision amount of 20u1 was injected into the human liquid chromatograph, and the chromatogram was recorded. Another cefmenoxime reference substance was taken and determined by the same method. The content of C16H17N905S3 in the sample was calculated by peak area according to external standard method.
Last Update：2022-01-01 14:21:58
7-[[(2-Amino-4-thiazolyl)(methoxyimino)acetyl]amino]-3-[[(1-methyl-1H-tetrazol-5-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid hemihydrochloride - Category
Authoritative Data Verified Data
B-lactam antibiotics, cephalosporins.
Last Update：2022-01-01 14:21:58
7-[[(2-Amino-4-thiazolyl)(methoxyimino)acetyl]amino]-3-[[(1-methyl-1H-tetrazol-5-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid hemihydrochloride - Storage
Authoritative Data Verified Data
sealed and stored in a cool dark dry place.
Last Update：2022-01-01 14:21:58
7-[[(2-Amino-4-thiazolyl)(methoxyimino)acetyl]amino]-3-[[(1-methyl-1H-tetrazol-5-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid hemihydrochloride - Cefmenoxime Hydrochloride for Injection
Authoritative Data Verified Data
This product is cefmenoxime hydrochloride with the right amount of anhydrous sodium carbonate as cosolvent made of sterile powder. The content of cefmenoxime (C16H17N905S3) shall be between 90.0% and 110.0% of the labeled amount calculated as the average loading.
trait
This product is white to light yellow crystal or crystalline powder.
identification
- 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 cefmenoxime hydrochloride under pH 6.8 phosphate buffer solution and diluted to prepare a solution containing cefmenoxime 15ug per 1 ml, according to UV-visible spectrophotometry (General 0401) the maximum absorption was measured at a wavelength of 232nm.
- take an appropriate amount of this product, add dilute acid, that is, effervescence, carbon dioxide, lead to calcium hydroxide solution, that is, white precipitation.
examination
- pH value: take this product, add water to make a solution containing about 0.lg of cefmenoxime per 1 ml, and determine it according to law (General rule 0631). The pH value should be 6.4~7.9.
- the clarity and color of the solution take 5 bottles of this product, and add water according to the labeled amount to make about 0 per 1 ml. lg solution, the solution should be clear and colorless, if it is turbid, compared with No. 1 turbidity standard solution (General 0902 first method), are not more concentrated; If the color, no deeper color shall be compared with the yellow or yellow-green Standard No. 7 color solution (General rule 0901 method 1).
- new system of related substances in clinical use. Weigh an appropriate amount of the contents of this product, add an appropriate amount of water to dissolve cefmenoxime hydrochloride, and then dilute it with mobile phase A to make A solution containing about 0.2mg of cefmenoxime per 1 ml as A test solution, if there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be greater than 1.5 times (1.5%) of the area of the main peak of the control solution, the sum of each impurity peak area shall not be greater than 4 times (4.0%) of the main peak area of the control solution.
- cefmenoxime polymer precise weighing the appropriate amount of the content of this product (equivalent to about 0.2g of cefmenoxime), put it in a 10ml measuring flask, add water to dissolve cefmenoxime hydrochloride and dilute it to the scale, shake well. The amount of cefmenoxime polymer shall not exceed 1.0% of the labeled amount, as determined by the method under cefmenoxime hydrochloride.
- weight loss on drying this product shall be dried under reduced pressure at 60°C for 3 hours, and the weight loss shall not exceed 1.5% (General rule 0831).
- insoluble particles this product is taken, and the solution containing about 20mg per 1 ml of water is prepared by adding particles to the labeled amount and checking according to law (General rule 0903), the labeled amount of less than 1.0g shall be converted to 6000 particles of 10um and more than lOum per 1.0g sample, and 600 particles of 25um and more than 25um; no more than 6000 particles of 10um and more than lOum and no more than 600 particles of 25um and more than 25um in each container of test article with labeled amount of 1.0g or more (including 1.og).
- bacterial endotoxin take this product, according to the law inspection (General 1143), each 1 mg cefmenoxime containing endotoxin amount should be less than 0.083EU.
- sterile take this product, add pH 7 0 sterile sodium chloride-peptone buffer solution and dilute to make a solution containing about 10 mg per 1 ml, and treat it by membrane filtration, wash with the above buffer (not less than 1101 per membrane), with Escherichia coli as positive control bacteria, according to the law (general rule), should comply with the provisions.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
The contents under the item of difference in loading amount were collected and mixed uniformly. Accurately weigh an appropriate amount, add an appropriate amount of water to dissolve cefmenoxime hydrochloride, and then quantitatively dilute with mobile phase to prepare a solution containing about 40ug of cefmenoxime per 1 ml, as a test solution, according to the method under the terms of cefmenoxime hydrochloride, obtained.
category
Same as cefmenoxime hydrochloride.
specification
calculated as C16H17N905S3 (l )0.25g (2 )0.5g(3)1.0g (4)2.0g
storage
shade, hermetically sealed, stored in a cool and dry place.
Last Update：2022-01-01 14:21:59
![7-[[(2-Amino-4-thiazolyl)(methoxyimino)acetyl]amino]-3-[[(1-methyl-1H-tetrazol-5-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid hemihydrochloride](http://res.chembk.com/assets/str/2d/7/75/75738-58-8.png)
Supplier List
Product Name: Cefmenoxime Hydrochloride Visit Supplier Webpage Request for quotation
CAS: 75738-58-8
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409
Wechat: 18301782025
CAS: 75738-58-8
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409
Wechat: 18301782025
Product Name: Cefmenoxime Hydrochloride Visit Supplier Webpage Request for quotation
CAS: 75738-58-8
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409
Wechat: 18301782025
CAS: 75738-58-8
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409
Wechat: 18301782025
View History