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Ceftriaxone Sodium

Ceftriaxone Sodium

CAS: 74578-69-1

Molecular Formula: C18H19N8NaO7S3

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Ceftriaxone Sodium - Names and Identifiers

Name Ceftriaxone Sodium
Synonyms Longaceph
CEFATRIAXONE
Ceftiaxone Sodium
CeftriaxoneSodium
Ceftriaxone Sodium
Ceftriaxone disodium
Ceftriaxonesodiumnon-steriled
2,5,6-tetrahydro-2-methyl-5,6-dioxo-)(methoxyimino)acetyl)amino)-8-oxo-3-(((
disodium (6R,7R)-7-{[(2Z)-2-(2-amino-1,3-thiazol-4-yl)-2-(methoxyimino)acetyl]amino}-3-{[(2-methyl-6-oxido-5-oxo-2,5-dihydro-1,2,4-triazin-3-yl)sulfanyl]methyl}-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate
5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7-[[(2Z)-(2-amino-4-thiazolyl)(methoxyimino)acetyl]amino]-8-oxo-3-[[(1,2,5,6-tetrahydro-2-methyl-5,6-dioxo-1,2,4-triazin-3-yl)thio]methyl]-, disodium salt, (6R,7R)-
5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7-[[(2-amino-4-thiazolyl)(methoxyimino)acetyl]amino]-8-oxo-3-[[(1,2,5,6-tetrahydro-2-methyl-5,6-dioxo-1,2,4-triazin-3-yl)thio]methyl]-, disodium salt, [6R-[6α,7β(Z)]]-
CAS 74578-69-1
EINECS 277-930-0
InChI InChI=1/C18H18N8O7S3.2Na/c1-25-18(22-12(28)13(29)23-25)36-4-6-3-34-15-9(14(30)26(15)10(6)16(31)32)21-11(27)8(24-33-2)7-5-35-17(19)20-7;;/h5,9,15H,3-4H2,1-2H3,(H2,19,20)(H,21,27)(H,23,29)(H,31,32);;/q;2*+1/p-2/b24-8-;;/t9-,15-;;/m1../s1

Ceftriaxone Sodium - Physico-chemical Properties

Molecular FormulaC18H19N8NaO7S3
Molar Mass578.57
Melting Point236°C
Specific Rotation(α)-160 ° (C=1, H2O)
Solubility H2O: soluble50mg/mL
AppearanceWhite or white-like crystalline powder
Storage Condition2-8℃
SensitiveSensitive to light
MDLMFCD01750405
Physical and Chemical PropertiesCeftriaxone sodium is the third generation of cephalosporin antibiotics, with broad-spectrum and efficient characteristics, it has bactericidal effect on many Gram-positive bacteria, negative bacteria and anaerobic bacteria, moreover, it is highly stable against most of the β-lactamases produced by the bacteria, thereby enhancing its antibacterial action.
UseFor the treatment of respiratory tract infections, urinary tract infections, gonorrhea and preoperative infection prevention

Ceftriaxone Sodium - Standard

Authoritative Data Verified Data

This product is (6R,7R)-7-[[(2Z)-(2-aminothiazol-4-yl) (methoxyimino) acetyl] amino]-3- [[(2-methyl-6-hydroxy-5-oxo-2, 5-dichloro-1, 2, 4-triazin-3-yl) thioyl] methyl]-8-oxo-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylic acid disodium salt threefold hemihydrate. Calculated as anhydrous, containing ceftriaxone (C18H18N807S3) shall not be less than 84.0%.

Last Update：2024-01-02 23:10:35

Ceftriaxone Sodium - Trait

Authoritative Data Verified Data
  • This product is white or off-white crystalline powder; Odorless.
  • This product is soluble in water, slightly soluble in methanol, and almost insoluble in 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 -153 ° to -170 °.

absorption coefficient

take this product, precision weighing, adding water to dissolve and quantitative dilution to make a solution containing about 10ug per lml, according to UV-visible spectrophotometry (General 0401), the absorbance was measured at a wavelength of 241mn, and the absorption coefficient was 495 to 545.

Last Update：2022-01-01 11:39:52

Ceftriaxone Sodium - 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 124).
  3. This product shows the reaction of sodium salt identification (1) (General rule 0301).
Last Update：2022-01-01 11:39:53

Ceftriaxone Sodium - Exam

Authoritative Data Verified Data

crystallinity

take this product, according to the law inspection (General 0981), should comply with the provisions.

pH

take this product, add water to make a solution containing about 0.12g per lml, and determine it according to law (General rule 0631). The pH value should be 6.0~8.0.

clarity and color of solution

take 5 parts of this product, each 0.6g, respectively, and add 5ml of water to dissolve. The solution should be clear and colorless; If it is turbid, compare it 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, yellow-green or orange-yellow No. 7 Standard Colorimetric solution (General Principles 0901 first method).

Related substances

take an appropriate amount of this product, add the mobile phase to dissolve and dilute to make a solution containing about 0.22mg per lml as a test solution; Take 1ml for precision measurement and put it in a 100ml measuring flask, dilute to the scale with the mobile phase, shake, and serve as a control solution. According to the chromatographic conditions under the content determination item, 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 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 2 times (2.0%) of the main peak area of the control solution.

ceftriaxone

polymers were determined by size exclusion chromatography (General 0514).

chromatographic conditions and system suitability test

using dextran gel G-10(40 to um) as a filler, the glass column has an inner diameter of 1.0 to 1.4 and a column length of 30 to 40. Mobile phase A was 0 at pH 7.0. lmol/L phosphate buffer [0.1 mol/L disodium hydrogen phosphate solution -0.1 mol/L sodium dihydrogen phosphate solution (61:39)], mobile phase B was water, the flow rate was about 1.5ml per minute, and the detection wavelength was 254nm. Take 0.4 ~ 200ul of 2000 mg/ml Blue dextran 100 solution and inject it into human liquid chromatograph, using mobile phase A and B as mobile phase respectively, record chromatogram, the theoretical plate number is not less than 2000 when the Blue dextran 400 peak is calculated, and the tailing factor should be less than 2.0. The ratio of the retention time 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 times 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. Weigh about 0.2g of ceftriaxone sodium, put it in a 10ml measuring flask, dissolve it in 2000 mg /ml Blue dextran solution, dilute it to the mark, and shake it well. Take 100-200ul injection liquid chromatograph, use mobile phase A to measure, record chromatogram. 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. The mobile phase B was used as the mobile phase, and the control solution 100~200 u1 was taken by precision children for continuous injection 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 ceftriaxone reference substance was accurately weighed, dissolved with water and quantitatively diluted to prepare a solution containing about 0.1 mg per 1 ml.

assay

take about 0.2g of this product, weigh it accurately, put it in a 10ml measuring flask, add water to dissolve and dilute to the scale, shake well, immediately take 100~200 u1 accurately, injection of human liquid chromatography, using mobile phase A as mobile phase for determination, record chromatogram. In addition, 100-200 u1 of the control solution was accurately weighed and injected into the liquid chromatograph, and the mobile phase B was used as the mobile phase, which was measured by the same method. According to the external standard method to calculate the peak area of ceftriaxone, the amount of polymer containing ceftriaxone should not exceed 0.5%.

residual solvent

take about lg of this product, put it in a 10ml measuring flask, add water to dissolve and dilute to the scale, shake well, use it as a stock solution for test, take 1ml for precision measurement, and place it in the top empty bottle, precision Add 1ml of water, shake, seal, as the test solution; Another precision weigh methanol 0.15g, ethanol 0.25g, acetone 0.25g and ethyl acetate 0.25g, put in 50ml measuring flask, add water to dissolve and dilute to the scale, shake. Take 10ml accurately, put it in a lOOml measuring flask, dilute to scale with water, shake well, and use it as a reference stock solution; Take 1ml of the reference stock solution, place it in a top empty bottle, add 1ml of water, and shake well, sealed, as the system applicable solution; Precision take the reference stock solution 1ml, in the top empty bottle, precision add human sample stock solution 1ml, shake, seal, as a reference solution. According to the determination method of residual solvent (General Principle 0861 first method), the capillary column with 100% dimethyl polysiloxane (or similar polarity) as stationary liquid is used as the column; The column temperature is 40°C; The detector temperature is 250°C; the inlet temperature is 200°C; The equilibrium temperature of the headspace bottle is 70°C, and the equilibrium time is 30 minutes; The system applicable solution is sampled by Headspace and the chromatogram is recorded. The peak order is: methanol, ethanol, acetone and ethyl acetate, the separation degree of each chromatographic peak should meet the requirements. Measure the sample solution and the reference solution respectively by Headspace injection, record the chromatogram, and calculate the peak area according to the standard addition method. The residual amount of methanol, ethanol, acetone and ethyl acetate shall meet the requirements.

moisture

take this product, according to the moisture determination method (General 0832 first method 1), the moisture content should be 8.0% ~ 11.0%.

Heavy metals

take this product lg, 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 2G, with the 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 make a solution containing 50mg per 1 ml with water for particle inspection, and check it 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 in each lg sample. (For aseptic dispensing)

bacterial endotoxin

take this product, check according to law (General rule 1143), the amount of endotoxin per 1 mg ceftriaxone should be less than 0.20EU. (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 11:39:54

Ceftriaxone 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 octylsilane was used as the filler; 0.02mol / L n-octylamine solution-acetonitrile (73:27) was used as the mobile phase, and the pH was adjusted to 6.5 with squamous acid; the detection wavelength was 254nm. Appropriate amount of ceftriaxone reference substance and ceftriaxone trans-isomer reference substance were dissolved and diluted with mobile phase to prepare 0.22mg Solutions per 1 mL respectively. 20 ml was injected into human liquid chromatograph, and the chromatogram was recorded, the resolution between ceftriaxone peak and ceftriaxone trans-isomer peak should be greater than 6.0.

assay

take about 22mg of this product, accurately weigh it, put it in a 100ml measuring flask, add the mobile phase to dissolve and dilute to the scale, shake it, and use it as a test solution, accurate measurement of 20u1 injection of human liquid chromatography, record chromatogram; Another appropriate amount of ceftriaxone reference, the same method for determination. The content in the test article was calculated by peak area according to external standard method.

Last Update：2022-01-01 11:39:55

Ceftriaxone Sodium - Category

Authoritative Data Verified Data

B-lactam antibiotics, cephalosporins.

Last Update：2022-01-01 11:39:55

Ceftriaxone Sodium - Storage

Authoritative Data Verified Data

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

Last Update：2022-01-01 11:39:56

Ceftriaxone Sodium - Ceftriaxone sodium for injection

Authoritative Data Verified Data

This product is a sterile powder of ceftriaxone sodium. Calculated as anhydrous, containing ceftriaxone (C18H18N807S3) shall not be less than 84.0%; Calculated as the average loading, containing ceftriaxone (C18H18N807S3) shall be 90.0% ~ 110.0% of the label amount.

trait

This product is white or white crystalline powder; Odorless.

identification

The same results were obtained according to the tests (1) and (3) under ceftriaxone sodium.

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, compared with No. 1 turbidity standard solution (General Principles 0902 first method), shall not be more concentrated; If the color is colored, with yellow, yellow-green or yellow-orange standard 9 color liquid (General Principles 0901 first method) comparison, shall not be deeper.
  • the contents under the item of difference in loading of related substances shall be determined according to the method for ceftriaxone sodium. The Peak area of a single impurity shall not be greater than the main peak area of the control solution (1.0% ), 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.
  • the content of ceftriaxone polymer under the item of difference in loading is determined according to the method of ceftriaxone sodium, and the ceftriaxone peak area is calculated according to the external standard method, the amount of ceftriaxone-containing polymer should not exceed 0.8% of the labeled amount.
  • insoluble particles this product is taken, and the labeled amount is added to the particle inspection water to make a solution containing 50mg per 1 ml, which is inspected according to law (General rule 0903), and the labeled amount is l. The conversion below Og is per l.Og sample containing 10um and more than 10um particles shall not exceed 6000, containing more than 600 particles; Label amount is l.Og or more (including l.Og) no more than 6000 particles with lOum and 10um or more and no more than 600 particles with 25um and 25um in each container of test article.
  • the pH, moisture, bacterial endotoxin and sterility shall be checked according to the method of ceftriaxone 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 obtained by measuring according to the method under the item of ceftriaxone sodium.

category

Same as ceftriaxone sodium.

specification

calculated by C18H18N807S3 (1)0.25g (2)0.5g(3)1.Og (4)2.Og (5) 4.og

storage

shade, hermetically sealed, stored in a cool and dry place.

Last Update：2022-01-01 11:39:57
Ceftriaxone Sodium
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Ceftriaxone Sodium
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