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)(methoxyimino)acetyl)amino)-3-(((5-(carboxymethyl)-4-methyl-2-thiazolyl)thio

Cefodizime sodium

CAS: 86329-79-5

Molecular Formula: C20H21N6NaO7S4

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)(methoxyimino)acetyl)amino)-3-(((5-(carboxymethyl)-4-methyl-2-thiazolyl)thio - Names and Identifiers

Name Cefodizime sodium
Synonyms kenicef
thr-221
Kenicef
Cefodizime sodium
Cefodizime disodium
Cefodizimedisodiumsalt
disodiumsalt,(6r-(6-alpha,7-beta(z)))-)methyl)-8-oxo
)(methoxyimino)acetyl)amino)-3-(((5-(carboxymethyl)-4-methyl-2-thiazolyl)thio
7-[[(2-amino-4-thiazolyl)(methoxyimino)acetyl]amino]-3-[[[5-(carboxymethyl)-4-methyl-2-thiazolyl]5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylicacid
7-(((2-amino-4-thiazolyl)(methoxyimino)acetyl)amino)-3-(((5-(carboxymethyl)-4-methyl-2-thiazolyl)th5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylicaci
7-(((2-amino-4-thiazolyl)(methoxyimino)acetyl)amino)-3-(((5-(carboxymethyl)-4-methyl-2-thiazolyl)thio)methyl)-8-oxo-5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic acid disodium salt
7-(((2-Amino-4-thiazolyl)(methoxyimino)acetyl)amino)-3-(((5-(carboxymethyl)-4-methyl-2-thiazolyl)thio)methyl)-8-oxo-5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic acid disodium salt
[7-[[(2E)-2-(2-aminothiazol-4-yl)-2-methoxyimino-acetyl]amino]-3-[[4-methyl-5-(2-oxo-2-sodiooxy-ethyl)thiazol-2-yl]sulfanylmethyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carbonyl]oxysodium
CAS 86329-79-5
InChI InChI=1/C20H20N6O7S4.2Na/c1-7-10(3-11(27)28)37-20(22-7)36-5-8-4-34-17-13(16(30)26(17)14(8)18(31)32)24-15(29)12(25-33-2)9-6-35-19(21)23-9;;/h6,13,17H,3-5H2,1-2H3,(H2,21,23)(H,24,29)(H,27,28)(H,31,32);;/q;2*+1/p-2/b25-12+;

)(methoxyimino)acetyl)amino)-3-(((5-(carboxymethyl)-4-methyl-2-thiazolyl)thio - Physico-chemical Properties

Molecular FormulaC20H21N6NaO7S4
Molar Mass608.65
Melting Point196 - 207°C
Solubility DMSO (Slightly), Methanol (Sparingly)
Appearancepowder
ColorWhite to Off-White
Storage Condition2-8°C
StabilityHygroscopic

)(methoxyimino)acetyl)amino)-3-(((5-(carboxymethyl)-4-methyl-2-thiazolyl)thio - Risk and Safety

ToxicityLD50 in mice, rabbits (mg/kg): 4000-8000 i.v. both species; in rats (mg/kg): 4000-8000 i.v., 15000-17500 s.c., 8000-11000 i.p. (Bryskier)

)(methoxyimino)acetyl)amino)-3-(((5-(carboxymethyl)-4-methyl-2-thiazolyl)thio - Standard

Authoritative Data Verified Data

This product is (6R,7R)-7 -[(Z) -2-(2-aminothiazol-4-yl) -2-(methoxyimino) acetamido] -3 -[(5-carboxymethyl-4-methylthiazol-2-yl) thiomethyl 8-oxo-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylic acid disodium salt. Calculated as anhydrous and ethanol-free, the content of C20H20N607S4 shall not be less than 88.0%.

Last Update：2024-01-02 23:10:35

)(methoxyimino)acetyl)amino)-3-(((5-(carboxymethyl)-4-methyl-2-thiazolyl)thio - Trait

Authoritative Data Verified Data
  • This product is white to yellowish powder or crystalline powder; Odorless or slightly specific odor.
  • This product is easily soluble in water, and almost insoluble in anhydrous ethanol or ether.

specific rotation

take this product, precision weighing, add water 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 was from 55 ° to -62 °.

absorption coefficient

take this product, precision weighing, add water to dissolve and quantitatively dilute to make a solution containing about 20ug per lml, according to UV-visible spectrophotometry (General 0401), the absorbance was measured at a wavelength of 260nm, and the absorption coefficient was 305 to 335.

Last Update：2022-01-01 11:39:44

)(methoxyimino)acetyl)amino)-3-(((5-(carboxymethyl)-4-methyl-2-thiazolyl)thio - 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. The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 922).
  3. This product shows the reaction of sodium salt identification (1) (General rule 0301).
Last Update：2022-01-01 11:39:44

)(methoxyimino)acetyl)amino)-3-(((5-(carboxymethyl)-4-methyl-2-thiazolyl)thio - Exam

Authoritative Data Verified Data

pH

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 5.5~7.5.

clarity and color of solution

take 5 parts of this product, respectively, add water to make each lml containing cefodizime 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. 9 (General Principles 0901 first method>).

Related substances I

new system for clinical use. Take about 25mg of this product, put it in a 50ml measuring flask, add the mobile phase to dissolve and dilute to the scale, shake well, as the test solution; Take 1ml of the test solution accurately, set in a 100ml measuring flask, dilute to the scale with the mobile phase, and shake to serve as a control solution. According to the chromatographic conditions under the content determination item, the detection wavelength is 215nm, and 20 u1 of the test solution and the control solution are accurately measured and injected into the human liquid chromatograph respectively, record the chromatogram to 6 times 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%), the sum of each impurity peak area shall not be greater than 1.5 times (1.5%) of the main peak area of the control solution.

Related substances II

new system for clinical use. Take appropriate amount of this product, precision weighing, add water to dissolve and quantitatively dilute to make a solution containing 0.5mg of cefodizime per lml, as a test solution; Take an appropriate amount of cefodizime reference, A solution containing about 5ug per 1ml was prepared as a control solution by precise weighing, dissolving with water and quantitatively diluting. Determined by size exclusion chromatography (General 0514). With spherical hydrophilic silica gel (molecular weight of 1000~10000) as the filler; Phosphate buffer (pH 7.0 )[0.0 5mol/L disodium hydrogen phosphate solution -0.005mol/L sodium dihydrogen phosphate solution (61:39 )]-acetonitrile (95:5) as mobile phase, flow rate of 0.8ml per minute, detection wavelength of 231mn. Take 10ml of test solution and add 0.1 mol/ L sodium hydroxide solution 1ml, room temperature for 10 minutes, plus 0.1 mol/ L hydrochloric acid solution 1ml, shake well, inject 20u1 into liquid chromatograph, record chromatogram; The separation degree between cefodizime peak and its adjacent degradation impurity peak should meet the requirements. Accurately take 20 u1 of the test solution and the control solution, respectively inject human liquid chromatograph, record the chromatogram; If there are impurity peaks in the chromatogram of the test solution, the total amount of impurity peaks with retention time less than cefodizime peak shall not exceed 1.5% calculated by external standard method with cefodizime peak.

residual solvent

take about 0.2g of this product, precision weighing, top empty bottle, precision plus internal standard solution (take a proper amount of N-propanol, dilute with water to make a solution containing lmg per lml) 2ml to dissolve, seal, as a test solution; Respectively, precision weighing dichloromethane 60mg, acetonitrile 41mg and ethanol about 2.0g, put in 50ml measuring flask, diluted to the scale with internal standard solution, shake well, take 5ml accurately, put it in a 100ml measuring flask, dilute it to the scale with internal standard solution, shake well, take 2ml accurately, put it in a top empty bottle, seal it, and use it as a reference solution. Determined according to the residual solvent assay (General 0861 first method). The capillary column with polyethylene glycol (PEG-20M)(or similar polarity) as stationary liquid was used as the chromatographic column, and the column temperature was 40°C; The detector temperature was 250°C; The inlet temperature was 200°C; the Headspace bottle equilibration temperature was 60°C and the equilibration time was 30 minutes. Take the reference solution into the headspace, record the chromatogram, and the separation degree between the chromatographic peaks shall meet the requirements. The test solution and the reference solution are injected in Headspace respectively, and the chromatograms are recorded. The residual amount of ethanol shall not exceed 2.0% based on the peak area ratio calculated by the internal standard method; The residual amount of acetonitrile and dichloromethane shall meet the requirements. 2-ethylhexanoic acid take the right amount of this product, according to the determination (General 0873), shall not exceed 0.5%.

moisture

take this product, according to the moisture determination method (General 0832 first method 1), the water content shall not exceed 4.0%.

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, respectively, plus particle inspection water dissolution, inspection according to law (General 0904), should comply with the provisions. (For aseptic dispensing)

insoluble particles

take this product, Add particle inspection water to dissolve and make a solution containing 30mg per lml, place it for 10 minutes, check according to law (General rule 0903), each lg sample containing 10um and 10um above the particle shall not exceed 6000, containing 25um and 25um above the particle shall not exceed 600. (For aseptic dispensing)

bacterial endotoxin

take this product, check according to law (General rule 1143), the amount of endotoxin per 1 mg of cefodizime should be less than 0.10EU. (For injection)

sterile

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)

Last Update：2022-01-01 11:39:46

)(methoxyimino)acetyl)amino)-3-(((5-(carboxymethyl)-4-methyl-2-thiazolyl)thio - Content determination

Authoritative Data Verified Data

measured by high performance liquid chromatography (General 0512).

chromatographic conditions and system suitability test

silica gel bonded with OCTA alkyl silane as filler; Phosphate buffer (take potassium dihydrogen phosphate 0.87g and anhydrous disodium hydrogen phosphate 0.22g, add water to dissolve and dilute to 1000ml, shake well)-acetonitrile (920:80) mobile phase; The detection wavelength was 262mn. Take 10ml of the control solution and add 0.1 mol/L hydrochloric acid solution 1 ml, room temperature for 24 hours, plus 0.lmol/L sodium hydroxide solution 1 ml, shake well, take 20ul injection liquid chromatograph, cefodizime peak and before and after the adjacent degradation of impurity peak separation degree should be greater than 3.0 and 4.0.

assay

take an appropriate amount of this product, weigh it accurately, add water to dissolve and quantitatively dilute it to make about 0. 5% cefodizime per 1 ml. 1 mg solution, shake, as a test solution, the precision of 20ul injection of human liquid chromatography, record chromatogram; Another appropriate amount of cefodizime reference, the same method for determination. The content of C20H20O7S4 in the sample was calculated by the peak area according to the external standard method.

Last Update：2022-01-01 11:39:46

)(methoxyimino)acetyl)amino)-3-(((5-(carboxymethyl)-4-methyl-2-thiazolyl)thio - Category

Authoritative Data Verified Data

B-lactam antibiotics, cephalosporins.

Last Update：2022-01-01 11:39:46

)(methoxyimino)acetyl)amino)-3-(((5-(carboxymethyl)-4-methyl-2-thiazolyl)thio - Storage

Authoritative Data Verified Data

sealed and stored in a cool dark dry place.

Last Update：2022-01-01 11:39:46

)(methoxyimino)acetyl)amino)-3-(((5-(carboxymethyl)-4-methyl-2-thiazolyl)thio - Cefodizime sodium for injection

Authoritative Data Verified Data

This product is a sterile powder of cefodizime sodium. The content of cefodizime (C20H20N607S4) shall not be less than 86.0% calculated as no water; The content of cefodizime (C20H20N607S4) shall be 90.0% ~ 110.0% of the label amount calculated as the average loading.

trait

This product is white to yellowish powder or crystalline powder; Odorless or slightly specific odor.

identification

According to the identification test under the item cefodizime sodium, the same results were shown.

examination

  • 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, 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. 10 (General rule 0901 method 1).
  • the contents of related substances I under the item of difference in loading, determined according to the method under the item of cefodizime sodium, the sum of each impurity peak area with retention time less than that of cefodizime peak shall not be greater than 2.5 times (2.5%) of the main peak area of the control solution.
  • insoluble particles this product is taken, and a solution containing 30mg per lml of water is prepared by adding particles to the labeled amount for inspection, and placed for 10 minutes for inspection according to law (General rule 0903), no more than 6000 particles with lOum and more than 10um and no more than 600 particles with 25um and more than 25um per 1.0g of sample shall be converted to the labeled amount of less than 1.0g; the marked amount is more than 1.0g (including 6000g), and the particles containing 10um and more than 10um in each sample container shall not exceed 600 particles, and the particles containing 25um and more than 25um shall not exceed particles.
  • the pH value, related substances I, moisture, bacterial endotoxin and sterility shall be checked according to the method under the item of cefodizime sodium, and shall be in accordance with the regulations.
  • 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 cefodizime sodium.

category

with cefodizime sodium.

specification

calculated as C20H20N607S4 (l)0.25g (2 )0.5g(3)1.0g (4)1.5g (5) 2.og

storage

sealed and stored in a cool dark dry place.

Last Update：2022-01-01 11:39:47
)(methoxyimino)acetyl)amino)-3-(((5-(carboxymethyl)-4-methyl-2-thiazolyl)thio
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Tel: +86-18821248368
Email: Int06@meryer.com
Mobile: +86-18821248368
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Product Name: Cefodizime sodium Request for quotation
CAS: 86329-79-5
Tel: 17505222756
Email: pules.cn@gmail.com
Mobile: +86-17551318830
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Product Name: Cefodizime sodium Visit Supplier Webpage Request for quotation
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Product Name: Cefodizime sodium Visit Supplier Webpage Request for quotation
CAS: 86329-79-5
Tel: +86-400-900-4166
Email: product@acmec-e.com
Mobile: +86-18621343501
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