ceftezole sodium
ceftezole sodium
CAS: 41136-22-5
Molecular Formula: C13H11N8NaO4S3
ceftezole sodium - Names and Identifiers
| Name | ceftezole sodium |
| Synonyms | Alomen Falomesin CEFTEZOLE SODIUM CDFTEZOLE SUDIUM ceftezole sodium 5-Thia-1-azabicyclo[4,2,0]oct-2-ene-2-carboxylic sodium 8-oxo-7-((1h-tetrazol-1-5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylicaci ylacetyl)amino)-3-((1,3,4-thiadiazol-2-ylthio)methyl)-,monosodiumsalt,(6r-t sodium (6S,7R)-8-oxo-7-[(1H-tetrazol-1-ylacetyl)amino]-3-[(1,3,4-thiadiazol-2-ylsulfanyl)methyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate 8-oxo-7-[(1h-tetrazol-1-ylacetyl)amino]-3-[(1,3,4-thiadiazol-2-ylthio)methyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid monosodium salt (6R)-7α-[[(1H-Tetrazol-1-yl)acetyl]amino]-3-[(1,3,4-thiadiazol-2-ylthio)methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid sodium salt |
| CAS | 41136-22-5 |
| EINECS | 1592732-453-0 |
| InChI | InChI=1/C13H12N8O4S3.Na/c22-7(1-20-4-14-18-19-20)16-8-10(23)21-9(12(24)25)6(2-26-11(8)21)3-27-13-17-15-5-28-13;/h4-5,8,11H,1-3H2,(H,16,22)(H,24,25);/q;+1/p-1/t8-,11+;/m1./s1 |
ceftezole sodium - Physico-chemical Properties
| Molecular Formula | C13H11N8NaO4S3 |
| Molar Mass | 462.46 |
| Storage Condition | Inert atmosphere,Store in freezer, under -20°C |
ceftezole sodium - Standard
Authoritative Data Verified Data
This product is (6R,7R)-3-[[(1,3, 4-thiadiazol-2-yl) thio] methyl]-7-[(1H-tetrazol-1-yl) acetylamino]-8-oxo-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylic acid sodium salt 3, calculated as anhydrous, containing ceftezole (C13H12N804S3) shall not be less than 90.0%.
Last Update：2024-01-02 23:10:35
ceftezole sodium - Trait
Authoritative Data Verified Data
- This product is white to light yellow powder or crystalline powder; Odorless, with hygroscopicity.
- This product is soluble in water, slightly soluble in methanol, and almost insoluble in ethanol and ether.
specific rotation
take this product, precision weighing, adding water to dissolve and quantitatively dilute to make about 0 in each lml. lg of the solution, determined according to law (General rule 0621), specific rotation -5 ° to -9%°.
absorption coefficient
take this product, precision weighing, add water to dissolve and quantitatively dilute to make a solution containing about 16ug per lml, according to UV-visible spectrophotometry (General 0401), the absorbance was measured at a wavelength of 272mn, and the absorption coefficient was 270 to 300.
Last Update：2022-01-01 11:41:40
ceftezole sodium - Differential diagnosis
Authoritative Data Verified Data
- take this product and add water to make a solution containing about 16ug per 1 ml. According to UV-visible spectrophotometry (General 0401), there is a maximum absorption at the wavelength of 272mn.
- 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 control (Spectrum set 1126).
- This product shows the reaction of sodium salt identification (1) (General rule 0301).
Last Update：2022-01-01 11:41:40
ceftezole sodium - 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 4.5~6.5.
clarity and color of solution
take 5 parts of this product, each 0.6g, 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. 6 (General Principles 0901 first method).
Related substances
take an appropriate amount of this product, add water to dissolve and dilute to make a solution containing about 1 mg per 1 ml, as a test solution; Take an appropriate amount of precision, A solution containing about 10ug per 1 ml was prepared as a control solution by quantitative dilution with water. The appropriate amount of the control solution was accurately taken, and the solution containing about 0.5ug per 1 ml was prepared by quantitative dilution with water as the sensitivity solution. According to the chromatographic conditions under the content determination item, take the sensitivity solution 20 u1, inject the human liquid chromatograph, record the chromatogram, and the signal to noise ratio of the main component peak height should be greater than 10. Then 20 u1 of the test solution and the control solution are accurately weighed and injected into the human liquid chromatograph respectively, and the chromatogram is recorded to 2.5 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 the area of the main peak of the control solution (1.0% ) , and the sum of each impurity peak area shall not be greater than 1.5 times (1.5%) of the area of the main peak of the control solution. No. The peaks in the chromatogram of the test solution which are smaller than the main peak area of the sensitivity solution are ignored.
ceftezole polymer
measured by size exclusion chromatography (General 0514).
chromatographic conditions and system suitability test
with dextran gel G-10(40 ~ 120um) as the filler, the inner diameter of the glass column is 1.0~1.4, the length of the column is 30 ~ 40cm, mobile phase A was 0.075mol/L phosphate buffer solution [0.075mol/L disodium hydrogen phosphate solution -0.075mol/L sodium dihydrogen phosphate solution (61:39)], the flow rate was 1.5ml per minute and the detection wavelength was 254nm. Take 0.4-200u1 of 2000 mg/ml Blue dextran 100 solution and inject it into human Liquid Chromatograph. Use mobile phase A and B as mobile phase respectively to record chromatogram. The number of theoretical plates shall not be less than 2000 based on the Blue dextran 300 peak, and the tailing factor shall be less than 2.0, the ratio of the retention times of the Blue dextran 2000 peak in the two mobile phase systems should be between 0.93 and 1.07, the ratio of the retention time of the main peak of the control solution to the polymer peak in the test solution and the Blue dextran 2000 peak in the corresponding chromatographic system should be between 0.93 and 1.07, weigh about 0.2g of this product, in A 10ml measuring flask, dissolve in 0.4mg/ml 2000 Blue dextran solution and dilute to the scale, shake well, inject 100~200u1 into human liquid chromatograph, and measure with mobile phase A, the ratio of the peak height of the high polymer to the valley height between the monomer and the high polymer should be greater than 2.0. In addition, the mobile phase B is used as the mobile phase, and 100~200 u1 of the control solution is accurately measured, and the sample is continuously injected for 5 times, the relative standard deviation of peak area should not be more than 5.0%.
preparation of control solution
an appropriate amount of ceftezole reference substance was accurately weighed, dissolved with water and quantitatively diluted to prepare a solution containing about 25ug per 1 ml. Determination of this product is about 0.3g, precision weighing, 10ml measuring flask, add water to dissolve and dilute to the scale, shake. Immediately, 100-200ul is injected into the liquid chromatograph accurately, mobile phase A is used as the mobile phase for measurement, and the chromatogram is recorded. In addition, 100-200u1 of the control solution was injected into the liquid chromatograph in a precise amount, the mobile phase B was used as the mobile phase for measurement, and the chromatogram was recorded. The amount of ceftezole polymer shall not exceed 0.05% calculated by the peak area of ceftezole according to the external standard method.
moisture
take this product, according to the determination of moisture (General 0832 first method 1), the water content shall not exceed 5.0%.
visible foreign body
take 5 parts of this product, each 4.0g, with particle inspection water dissolution, inspection according to law (General 0904), should comply with the provisions. (For aseptic dispensing)
insoluble particles
Take 3 parts of this product, and use the particle inspection water to make a solution containing 60mg per 1 ml, and check according to law (General rule 0903), no more than 6000 particles of 10um and more than 10um in each lg sample, and no more than 600 particles of 25um and more than 25um. (For aseptic dispensing)
bacterial endotoxin
take this product, check according to law (General rule 1143 ), the amount of endotoxin per 1 mg ceftezole should be less than 0.075EU. (For injection)
sterile
take this product, dissolve and dilute with sterile water, after membrane filtration treatment, inspection according to law (General rule 1101), should comply with the provisions. (For aseptic dispensing)
Last Update：2022-01-01 11:41:41
ceftezole sodium - 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; Citric acid solution (3g of citric acid was taken, dissolved in water and diluted to 900ml)-acetonitrile (90:10) was used as mobile phase; the detection wavelength was 254nm. Take about 25mg of ceftezole reference, put it in a 25ml measuring flask, add 0.1 mol/L sodium hydroxide solution (1 ml) was dissolved and placed for 1 min. lmol/L hydrochloric acid solution (lml) was neutralized, diluted with water to scale, to obtain a mixed solution containing about ceftezole lmg and its degradation impurities per 1 mL (wherein the amounts of impurities at relative retention times of about 0.8 and 1.7 are about 0.5% and 2% ), take 20u1 injection human liquid chromatograph, record chromatogram, ceftezole peak retention time is about 13 minutes, ceftezole peak and its relative retention time is about 0.8, the separation degree between impurity peaks should be greater than 4.0.
assay
take an appropriate amount of this product, accurately weigh it, add water to dissolve it and quantitatively dilute it to make a solution containing about 0.2mg per lml, as a test solution, and take 20ul of the precision quantity to inject human liquid chromatograph, record the chromatogram; Take the appropriate amount of ceftezole reference, and determine with the same method. The content of C13H12N804S3 in the test sample was calculated by the peak area according to the external standard method.
Last Update：2022-01-01 11:41:42
ceftezole sodium - Category
Authoritative Data Verified Data
B-lactam antibiotics, cephalosporins.
Last Update：2022-01-01 11:41:42
ceftezole sodium - Storage
Authoritative Data Verified Data
sealed and stored in a cool dark dry place.
Last Update：2022-01-01 11:41:42
ceftezole sodium - Ceftezole sodium for injection
Authoritative Data Verified Data
This product is ceftezole sodium sterile powder. Calculated as anhydrous, containing ceftezole (C13H12N804S3) shall not be less than 90.0%; Calculated as the average loading, containing ceftezole (C13H12N804S3) shall be 90.0% ~ 110.0% of the label amount.
trait
This product is white to light yellow powder or crystalline powder; Odorless, with hygroscopicity.
identification
take this product, according to ceftezole sodium under the identification test, showed the same results.
examination
- the clarity and color of the solution take 5 bottles of this product, and add water according to the labeled amount to make 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 No. 7 color solution (General rule 0901 method 1).
- the moisture content of this product shall not exceed 0832 as determined by the method for determination of moisture (General rule 5.5%, first method 1).
- insoluble particles the product shall be taken, and a solution containing 60mg per 1 ml made of water for particle inspection shall be inspected according to law (General rule 0903), and the labeled amount shall be less than G, the conversion is that the particles containing 10um and l0um or more in each lg sample shall not exceed 6000 particles, and the particles containing 25um and 25um or more shall not exceed 600 particles. Label amount is 1.0g or more (including l.Og), each sample container containing 10um and 10um or more particles shall not exceed 6000 particles, containing 25um and 25um or more particles shall not pass 600 particles.
- the acidity, related substances, ceftezole polymer, bacterial endotoxin and sterility should be checked according to the method of ceftezole 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 under the item of ceftezole sodium.
category
Same as ceftezole sodium.
specification
calculated by C13H12N804S3 (1)0.25g (2)0.5g(3)0.75g (4)1.0g (5)1.5g (6)2.Og (7)4.0g
storage
sealed and stored in a cool dark dry place.
Last Update：2022-01-01 11:41:43
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Product Name: ceftezole sodium Request for quotation
CAS: 41136-22-5
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CAS: 41136-22-5
Tel: 17505222756
Email: pules.cn@gmail.com
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