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(6R,

(6r-(6-alpha,7-alpha))-7-((((2-amino-2-carboxyethyl)thio)acetyl)amino)-7-methoxy-3-(((1-methyl-1h-tetrazol-5-yl)thio)methyl)-8-oxo-5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic acid monosodium salt

CAS: 92636-39-0;75498-96-3;88641-36-5

Molecular Formula: C16H20N7NaO7S3

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(6R, - Names and Identifiers

Name (6r-(6-alpha,7-alpha))-7-((((2-amino-2-carboxyethyl)thio)acetyl)amino)-7-methoxy-3-(((1-methyl-1h-tetrazol-5-yl)thio)methyl)-8-oxo-5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic acid monosodium salt
Synonyms (6R,
Tencef
MT-141
Meicelin
Alteporina
Cefminox sodium
7beta-[2-[2(S)-Amino-2-carboxyethylthio]acetamido]-7alpha-methoxy-3-(1-methyl-1H-tetrazol-5-ylthiomethyl)-3-cephem-4-carboxylic acid sodium salt
6R,7S)-7-[[[[(2S)-2-Amino-2-carboxyethyl]thio]acetyl]amino]-7-methoxy-3-[[(1-methyl-1H-tetrazol-5-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid sodium salt
(6R,7S)-7-[[[[(2S)-2-Amino-2-carboxyethyl]thio]acetyl]amino]-7-methoxy-3-[[(1-methyl-1H-tetrazol-5-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid sodium salt
(6R-(6-,7-))-7-((((2-Amino-2-carboxyethyl)thio)acetyl)amino)-7-methoxy-3-(((1-methyl-1H-tetrazol-5-yl)thio)methyl)-8-oxo-5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic acid monosodium salt
(6R,7S)-7-[[2-[[(2S)-2-Amino-2-carboxyethyl]thio]acetyl]amino]-7-methoxy-3-[[(1-methyl-1H-tetrazol-5-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid monosodium salt
(6R-(6-alpha,7-alpha))-7-((((2-Amino-2-carboxyethyl)thio)acetyl)amino)-7-methoxy-3-(((1-methyl-1H-tetrazol-5-yl)thio)methyl)-8-oxo-5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic acid monosodium salt
(6r-(6-alpha,7-alpha))-7-((((2-amino-2-carboxyethyl)thio)acetyl)amino)-7-methoxy-3-(((1-methyl-1h-tetrazol-5-yl)thio)methyl)-8-oxo-5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic acid monosodium salt
CAS 92636-39-0
75498-96-3
88641-36-5
InChI InChI=1/C16H21N7O7S3.Na/c1-22-15(19-20-21-22)33-4-7-3-32-14-16(30-2,13(29)23(14)10(7)12(27)28)18-9(24)6-31-5-8(17)11(25)26;/h8,14H,3-6,17H2,1-2H3,(H,18,24)(H,25,26)(H,27,28);/q;+1/p-2/t8-,14-,16+;/m1./s1

(6R, - Physico-chemical Properties

Molecular FormulaC16H20N7NaO7S3
Molar Mass541.56
Melting Point90-91 °C
Solubility DMSO
AppearanceSolid
ColorWhite to Pale Yellow
Storage ConditionKeep in dark place,Inert atmosphere,Store in freezer, under -20°C
UseCephalosporins

(6R, - Standard

Authoritative Data Verified Data

This product is (+)-(6R,7S)-7-[(S)-2-(2-amino-2-carboxyethylthio) acetamido] -7-methoxy-3-[[(l-methyl -1H-tetrazol-5-yl) thioyl] methyl]-8 oxo-5-thia-1-azabicyclo [4. 2. Oct-2-ene-2-carboxylic acid sodium heptahydrate. The content of cefminox (C16H21N707S3) shall not be less than 91.0% calculated as anhydrous.

Last Update：2024-01-02 23:10:35

(6R, - Trait

Authoritative Data Verified Data
  • This product is white or off-white crystalline powder, odorless or slightly odorous.
  • This product is soluble in water, slightly soluble in methanol, and insoluble in anhydrous ethanol, ether or acetone.

specific rotation

take this product, precision weighing, water dissolution and quantitative dilution of about 5mg per lml solution, according to the law (General 0621), the specific rotation should be 76 ° to 89 °.

absorption coefficient

take this product, precision weighing, add water to dissolve and quantitatively dilute to make a solution containing about 20ug of cefminox per lml, according to UV-visible spectrophotometry (General 0401), the absorbance was measured at a wavelength of 273nm, and the absorption coefficient was 195 to 220.

Last Update：2022-01-01 11:39:58

(6R, - Preparation solution concentration reference

 1mg5mg10mg
1 mM1.847 ml9.233 ml18.465 ml
5 mM0.369 ml1.847 ml3.693 ml
10 mM0.185 ml0.923 ml1.847 ml
5 mM0.037 ml0.185 ml0.369 ml
Last Update：2024-01-02 23:10:35

(6R, - Differential diagnosis

Authoritative Data Verified Data
  1. 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.
  2. take an appropriate amount of this product, add water to dissolve and dilute to prepare a solution containing about 20ug of cefminox per lml, and measure it by UV-Vis spectrophotometry (General rule 0401), there is an absorption maximum at a wavelength of 273NM.
  3. The infrared absorption spectrum of this product should be consistent with that of the reference product (General rule 0402).
  4. This product shows the reaction of sodium salt identification (1) (General rule 0301).
Last Update：2022-01-01 11:39:58

(6R, - Exam

Authoritative Data Verified Data

acidity

take this product, add water to make a solution containing 70mg of cefminox per lml, and determine it according to law (General rule 0631). The pH value should be 4.5~6.0.

clarity and color of solution

take 5 parts of this product, each 0.625g, 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. 5 (general principles 0901 first method).

Related substances I

take an appropriate amount of this product, add the mobile phase to dissolve and dilute to make about 1 of cefminox per 1 ml. 0 mg of solution, as the test solution; Precision take appropriate amount, quantitative dilution with mobile phase to make the solution containing about 10ug of cefminox per 1 ml, as a control solution; the control solution (1 ml) was quantitatively diluted with the mobile phase to prepare a solution containing about 0.5ug of cefminox per 1 ml as a sensitivity solution. According to the chromatographic conditions under the content determination, the sensitivity solution 10ul is injected into the liquid chromatograph, and the signal to noise ratio of the main component peak height should be greater than 10. 10 u1 of the test solution and the control solution were respectively injected into the liquid chromatograph, and the chromatogram was recorded to 3.5 times of 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 0.5 times (0.5%) of the area of the main peak of the control solution, the sum of each impurity peak area shall not be greater than 1.5 times of the main peak area of the control solution (1. 5%). The peaks in the chromatogram of the test solution which are smaller than the main peak area of the sensitivity solution are ignored.

Related substances II

new system for clinical use. Take an appropriate amount of this product, weigh it accurately, add water to dissolve and quantitatively dilute it to make about 1 cefminox per lml. 0 mg of the solution, as the test solution; Another appropriate amount of cefminox reference substance, precision weighing, dissolved and quantitatively diluted with water to make a solution containing about 5 ml per 1ml, as a control solution; 1ml of the control solution was quantitatively diluted with the mobile phase to prepare a solution containing about 0.2ug per 1ml as a sensitivity solution. Determined by size exclusion chromatography (General 0514). Using spherical hydrophilic modified silica gel (molecular weight of polymer 500~15000) as filler (TSK-GEL G2000swxl, 7.8mm X 30cm,5um or equivalent chromatography column with phosphate buffer (pH 7.0)[0.0.005mol/L sodium dihydrogen phosphate solution -0.8 mol/L sodium dihydrogen phosphate solution (61:39)]-acetonitrile (95:5) as mobile phase, the flow rate was ml per minute, the detection wavelength was 254nm. 10ml of the sample solution was taken, 1ml of 0.1 mol/L sodium hydroxide solution was added, and the solution was placed at room temperature for 1 minute. 1ml of 0.1 mol/L hydrochloric acid solution was added, and the solution was shaken to be the applicable solution of the system. 10u1 is injected into the liquid chromatograph, and the chromatogram is recorded. The retention time of cefminox peak is about 12 minutes, and the separation degree between cefminox peak and its adjacent degradation impurity peak should meet the requirements. The sensitivity solution l0ul was injected into the human liquid chromatograph, and the chromatogram was recorded. The signal-to-noise ratio of the main component peak height should be greater than 10. l0ul of the test solution and the control solution are respectively injected into the liquid chromatograph to record the chromatogram. If there are impurity peaks in the chromatogram of the test solution, the Peak area of impurities with relative retention time between 0.82 and 1.0 shall not be greater than the main peak area of the control solution (0.5%), the sum of impurity peak areas with relative retention time less than 0.82 shall not be greater than 0.6 times (0.3%) of the main peak area of the control solution, and the peaks in the chromatogram of the test solution which are smaller than the main peak area of the sensitive solution are ignored.

residual solvent

methanol, ethanol, acetone, dichloromethane, ethyl acetate, dichloroethane, isopropanol and dioxane take about l.Og, precision weighing, put in 10ml measuring flask, add water to dissolve and dilute to the scale, shake, as a sample stock solution, take the precision of lml in the top empty bottle, Precision Add 1ml water, sealed, as a test solution; Precision weighing the appropriate children of each solvent, dissolved in water and quantitatively diluted into methanol 0.3mg, ethanol 0.5mg, acetone 0.5mg per 1ml, dichloromethane 0.06mg, ethyl acetate 0.5mg, dichloroethylene 0.0005mg, isopropanol 0.5mg and dioxane 0.038mg mixed reference solution, shake, take 1ml, place in empty bottle, then, 1ml of a stock solution of human test article was added precisely, sealed, and used as a reference solution. According to the determination method of residual solvent (General rule 0861 second method), the capillary column (membrane thickness not less than 1.0um) with dimethyl polysiloxane (or similar polarity) as stationary liquid is used as the column; The initial temperature is 35°C, maintain 7 minutes, at a rate of 2CTC per minute to 220°C, maintain 4 minutes; Injection port temperature is 200°C; Detector temperature is 250°C; Head space equilibrium temperature is 70°C, the equilibration time was 30 minutes. The reference solution is injected in the headspace, and the peak order is methanol, ethanol, acetone, isopropanol, ethyl dimethane acetate, dichloroethane and dioxane, and the separation degree between peaks shall meet the requirements, take the reference solution and the test solution into the headspace respectively, record the chromatogram, calculate the peak area according to the standard addition method, methanol, ethanol, acetone, two gas methane, ethyl acetate, dichloroethane, isopropyl alcohol and dioxane residues shall be in accordance with the provisions.

toluene, anisole and N,N-dimethylaniline

take this product 1.0g, precision weighing, 120ml measuring flask, add methanol-water (60:40) to dissolve and dilute to the scale, shake, as the test solution; In addition, accurately weigh about 0.089g of toluene, about 0.5g of anisole and about 0.02g of N,N-dimethylaniline respectively, and put them in a 20ml measuring flask, add anhydrous ethanol to dissolve and dilute to the scale, shake well, take 5ml accurately, put it in 50ml measuring flask, add methanol-water (60:40) to dilute to the scale, shake well, as a control solution. According to the determination method of residual solvent (General Principle 0861 third method), the capillary column with 6% cyanopropylphenyldimethylsiloxane (or similar polarity) as the stationary liquid is used as the column; The initial temperature is 40°C, and the maintenance time is 5 minutes, the temperature was raised to 200°C at a rate of 30°C per minute for 3 minutes; The inlet temperature was 200°C; And the detector temperature was 250°C. The lul of the reference solution and the test solution were accurately measured, respectively injected into the human gas chromatograph, and the chromatogram was recorded. The area of the oyster was calculated according to the external standard method. Toluene residues should be in accordance with the provisions; Anisole residues should not exceed 0.5%;N,N-dimethylaniline residues should not exceed 0.02%.

moisture

take this product, according to the moisture determination method (General 0832 first method 1), the moisture content should be 18.0% ~ 20.0%.

Heavy metals

take this product l.O g, inspection according to law (General Principles 0821 second law), containing heavy metals shall not exceed 10 parts per million.

visible foreign body

take 5 parts of this product, each 2.Og, plus particle inspection water dissolution, according to the law inspection (General 0904), should comply with the provisions. (For aseptic dispensing)

insoluble particles

Take 3 parts of this product, each 2.Og, plus particle inspection water to make a solution containing about 30mg per 1 ml, and check according to law (General rule 0903), no more than 6000 particles of l0um and 10um or more in each lg sample, and no more than 600 particles of 25um and 25um or more. (For aseptic dispensing)

bacterial endotoxin

take this product, check according to law (General rule 1143), each 1 mg of cefminox containing endotoxin should be less than 0.050EU. (For injection)

sterile

take this product, dissolve and dilute with 0.9% sterile sodium chloride solution to prepare a solution containing 40mg of cefminox per 1 ml. After treatment by membrane filtration, sterile gasified sodium-peptone aqueous solution (pH 7.0) was washed in portions (not less than 500ml per membrane). Escherichia coli as positive control bacteria, according to the law inspection (General 1101), should comply with the provisions. (For aseptic dispensing)

Last Update：2022-01-01 11:39:59

(6R, - 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 the filler; Acetic acid solution (1-100)-methanol-tetrahydrofuran (990:5:5) was used as the mobile phase, and the detection wavelength was 254nm. A suitable amount of cefminox system applicable reference substance is taken, dissolved by adding water and diluted to prepare a solution containing about 1 mg per 1 ml, and 10u is injected into the human Liquid Chromatograph. The chromatogram recorded should be consistent with the standard spectrum.

assay

take an appropriate amount of this product, weigh it accurately, add water to dissolve and quantitatively dilute it to make lml containing about cefminox 1. The solution of 0 mg was used as the test solution, and 10u1 was injected into the human liquid chromatograph for precise measurement, and the chromatogram was recorded. According to the external standard method, the content of the test article is calculated by the peak area.

Last Update：2022-01-01 11:40:00

(6R, - Category

Authoritative Data Verified Data

B-| Lactam antibiotics, cephalosporins.

Last Update：2022-01-01 11:40:01

(6R, - Storage

Authoritative Data Verified Data

shade, seal, and store in a cool, dry place.

Last Update：2022-01-01 11:40:01

(6R, - Cefminox Sodium for Injection

Authoritative Data Verified Data

This product is a sterile powder of cefminox sodium. The content of cefminox (C16H21N707S3) shall not be less than 91.0% calculated as anhydrous. Based on the average loading, containing cefminox (C16H21N707S3) shall be 90.0% ~ 110.0% of the labeled amount.

trait

This product is white or off-white crystalline powder, odorless or slightly odorous.

identification

According to the identification test under the term cefminox sodium, the same results were 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 should be checked immediately according to the law, and the solution should be clear and colorless; If it is turbid, it should not be more concentrated than the No. 1 turbidity standard solution (General 0902 first method); If it is colored, no deeper than the yellow or yellow-green standard colorimetric solution No. 5 (general rule 0901 method 1).
  • insoluble particles take this product, add particles to the labeled amount and check it to dissolve with water and make a solution containing about 30mg per 1 ml, and check it according to law (General rule 0903). The labeled amount is l.O g or less is converted to each l. No more than 6000 particles with lOum or more and no more than 600 particles with 25um or more in Og sample; The labeled amount is more than 1.0g (including g). No more than 6000 particles of lOum or more and no more than 600 particles of 25um or more should be contained in each sample container.
  • the acidity, related substances I, related substances II, moisture, endotoxin in the seedling and sterility shall be checked according to the method of cefminox sodium.
  • others should comply with the relevant provisions under injection (General 0102).

Content determination

The content under the item of loading amount difference was obtained by measuring according to the method of cefminox sodium under the item.

category

Same as cefminox sodium.

specification

calculated by C16H21N707S3 (1)0.25g (2)0.5g(3)1.Og (4) 1.5g (5)2.Og

storage

sealed, stored in a cool, dry place.

Last Update：2022-01-01 11:40:02
(6R,
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