5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7-[[(2-amino-4-thiazolyl)[(carboxymethoxy)imino]acetyl]amino]-3-ethenyl-8-oxo-, [6R-[6α,7α(Z)]]-
Cefixime
CAS: 79350-37-1;108691-83-4
Molecular Formula: C16H15N5O7S2
5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7-[[(2-amino-4-thiazolyl)[(carboxymethoxy)imino]acetyl]amino]-3-ethenyl-8-oxo-, [6R-[6α,7α(Z)]]- - Names and Identifiers
5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7-[[(2-amino-4-thiazolyl)[(carboxymethoxy)imino]acetyl]amino]-3-ethenyl-8-oxo-, [6R-[6α,7α(Z)]]- - Physico-chemical Properties
| Molecular Formula | C16H15N5O7S2 |
| Molar Mass | 453.45 |
| Density | 1.85±0.1 g/cm3(Predicted) |
| Melting Point | 218-225°C |
| Water Solubility | 55.11 mg/L |
| Solubility | Slightly soluble in water, soluble in methanol, sparingly soluble in anhydrous ethanol, practically insoluble in ethyl acetate. |
| Appearance | Solid |
| Color | Off-White to Pale Yellow |
| pKa | pKa 2.10 (Uncertain) |
| Storage Condition | Keep in dark place,Inert atmosphere,2-8°C |
| Stability | Hygroscopic |
| Physical and Chemical Properties | Melting point 218-225°C water-soluble 55.11 mg/L |
| Use | Cephalosporins |
5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7-[[(2-amino-4-thiazolyl)[(carboxymethoxy)imino]acetyl]amino]-3-ethenyl-8-oxo-, [6R-[6α,7α(Z)]]- - Risk and Safety
| Hazard Symbols | Xn - Harmful |
| Risk Codes | 42/43 - May cause sensitization by inhalation and skin contact. |
| Safety Description | S22 - Do not breathe dust. S36/37 - Wear suitable protective clothing and gloves. S45 - In case of accident or if you feel unwell, seek medical advice immediately (show the label whenever possible.) |
| WGK Germany | 3 |
| FLUKA BRAND F CODES | 10-23 |
| HS Code | 38210000 |
| Toxicity | LD50 oral in rat: > 10gm/kg |
5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7-[[(2-amino-4-thiazolyl)[(carboxymethoxy)imino]acetyl]amino]-3-ethenyl-8-oxo-, [6R-[6α,7α(Z)]]- - Standard
Authoritative Data Verified Data
This product is (6R,7R)- 7 -[[( 2 )-2 -(2-amino-4-thiazolyl)-2-[(carboxymethoxy)] imino] acetyl] amino]-3-vinyl-8-oxo-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylic acid trihydrate. The content of cefixime (calculated as C16H15N507S2) shall not be less than 95.0% calculated as anhydrous.
Last Update：2024-01-02 23:10:35
5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7-[[(2-amino-4-thiazolyl)[(carboxymethoxy)imino]acetyl]amino]-3-ethenyl-8-oxo-, [6R-[6α,7α(Z)]]- - Trait
Authoritative Data Verified Data
- This product is white to light yellow crystalline powder, odorless or slightly special odor.
- This product is dissolved in methanol, slightly soluble in ethanol, insoluble in water or ether.
specific rotation
take this product, precision weighing, dissolved and quantitatively diluted with 2% sodium bicarbonate solution to make a solution containing about 10mg per 1 ml, and determine according to law (General rule 0621), the specific rotation should be from one 75 ° to one 88 °.
Last Update：2022-01-01 11:40:03
5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7-[[(2-amino-4-thiazolyl)[(carboxymethoxy)imino]acetyl]amino]-3-ethenyl-8-oxo-, [6R-[6α,7α(Z)]]- - 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. If there is any difference, the appropriate amount of this product and the reference product can be taken respectively, and dissolved with methanol. After volatile solvent, the residue can be determined by infrared spectrophotometry (General rule 0402), the infrared absorption spectra of the two should be consistent.
Last Update：2022-01-01 11:40:03
5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7-[[(2-amino-4-thiazolyl)[(carboxymethoxy)imino]acetyl]amino]-3-ethenyl-8-oxo-, [6R-[6α,7α(Z)]]- - Exam
Authoritative Data Verified Data
acidity
take this product, add water to make a suspension containing 0.7mg per lml, and determine it according to law (General rule 0631). The pH value should be 2.6~4.1.
Related substances
take an appropriate amount of this product, add phosphate buffer (pH 7.0) to dissolve and dilute to prepare a solution containing about 1 mg per 1 ml as a test solution; the appropriate amount of the test solution was taken accurately and diluted quantitatively with phosphate buffer (pH 7.0) to make about 0.Olmg solution, 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 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 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 3 times (3.0%) of the main peak area of the control solution, and the peaks in the chromatogram of the test solution which are smaller than 0.1 times of the main peak area of the control solution are ignored.
residual solvent
determined as residual solvent assay (General 0861).
chromatographic conditions and system suitability test
A capillary column with 6% cyanopropylphenyl-94% dimethylpolysiloxane as the stationary liquid (or similar polarity) is used as the column, and the starting temperature is 40°C, and the retention time is 22 minutes, then the temperature is increased to 100°C at a rate of 120°C per minute for 10 minutes, the temperature of the injection port is 200°C, the temperature of the detector is 250°C, and the equilibrium temperature of the headspace bottle is 70°C, the equilibration time was 30 minutes. The system applicable solution is injected in Headspace, and the peaks are generated in the order of ethanol, ether and N-propanol (internal standard), and the separation degree between peaks shall meet the requirements.
preparation of internal standard solution
an appropriate amount of N-propanol was taken and diluted with N,N-dimethylformamide to a solution containing about 200ug per 1 ml as an internal standard solution. Preparation of the applicable solution of the system take appropriate amounts of ethanol and ether respectively, and dilute quantitatively with internal standard solution to make a solution containing about 1 mg of ethanol and ether in each lml, and take 1.0ml for precise measurement, top empty bottle, sealed, as the system applicable solution.
preparation of test solution
take about 0.2g of this product, precision weighing, top empty bottle, precision add 1.0ml internal standard solution to dissolve, seal, as a test solution. Preparation of control solution a control solution was prepared according to the specific test object determined by the test. Accurately weigh the appropriate amount of the solvent reference substance, and quantitatively dilute it with the internal standard solution to prepare the solution of the specified concentration as the mixed reference solution, the concentration of each solvent in the mixed reference solution was 60ug of methanol, 1 mg of ethanol, 1 mg of acetic acid, 1 mg of acetone, 1 mg of isopropyl alcohol, 120ug of dichloromethane, 1 mg of isopropyl ether, 150ug of tetrahydrofuran, 1 mg of isopropyl ether, ethyl acetate lmg, isopropyl acetate lmg, pyridine 40ug, anisole lmg. 1.0ml of the mixed reference solution was accurately measured, placed in a top empty bottle, sealed, and used as a reference solution.
assay
first, methane gas was injected in the headspace, the retention time of methane was recorded as the dead time (to) of the chromatographic system, and then the test solution was injected in the headspace, and the chromatogram was recorded. Determine the type of residual solvent in the test sample; Prepare the corresponding reference solution, and inject the sample into the headspace
Product solution, record the chromatogram, according to the internal standard method to calculate the peak area ratio of the content of each residual solvent in the sample. Isopropyl ether and anisole residues are not more than 0.5%, methanol, ethanol, ether, acetone, isopropyl alcohol, two gas methane, ethyl acetate, Tetrahydrofuran, isopropyl acetate and pyridine residues should be in accordance with the provisions.
moisture
take this product, according to the moisture determination method (General 0832 first method 1), the moisture content should be 9.0% ~ 12.0%.
ignition residue
take l.Og of this product and check it according to law (General rule 0841). The residue left shall not exceed 0.2%.
Heavy metals
The residue left under the item of taking the ignition residue shall not contain more than 20 parts per million of heavy metal when examined by law (General rule 0821, Law II).
Last Update：2022-01-01 11:40:04
5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7-[[(2-amino-4-thiazolyl)[(carboxymethoxy)imino]acetyl]amino]-3-ethenyl-8-oxo-, [6R-[6α,7α(Z)]]- - 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 as filler; Tetrabutylammonium hydroxide solution (take 25ml of 10% tetrabutylammonium hydroxide solution, add 1.5 ml of water, shake well, and adjust the pH value to 7.0 with mol/L phosphoric acid solution)-Acetonitrile (72:28) as mobile phase; The detection wavelength was 254nm; The column temperature was 40 ° C. The appropriate amount of cefixime reference substance was taken, dissolved in water and diluted to prepare a solution containing about 1 mg per 1 ml, it was heated in a boiling water bath for 45 minutes and cooled. Take 20u1 injection human liquid chromatograph, record chromatogram, according to (E) isomer, cefixime peaks in the order,(E) isomer peak and cefixime peak separation degree should meet the requirements.
assay
take this product, precision weighing, adding mobile phase dissolution and quantitative dilution to make a solution containing about 0.2mg per 1 ml, as a test solution, precision children take 20ul injection of human liquid chromatography, record the chromatogram; Take the appropriate amount of cefixime reference substance, the same method for determination. According to the external standard method to calculate the peak area, that is.
Last Update：2022-01-01 11:40:05
5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7-[[(2-amino-4-thiazolyl)[(carboxymethoxy)imino]acetyl]amino]-3-ethenyl-8-oxo-, [6R-[6α,7α(Z)]]- - Category
Authoritative Data Verified Data
B-lactam antibiotics, cephalosporins.
Last Update：2022-01-01 11:40:05
5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7-[[(2-amino-4-thiazolyl)[(carboxymethoxy)imino]acetyl]amino]-3-ethenyl-8-oxo-, [6R-[6α,7α(Z)]]- - Storage
Authoritative Data Verified Data
shade, seal, and store in a cool place.
Last Update：2022-01-01 11:40:05
5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7-[[(2-amino-4-thiazolyl)[(carboxymethoxy)imino]acetyl]amino]-3-ethenyl-8-oxo-, [6R-[6α,7α(Z)]]- - Cefixime tablets
Authoritative Data Verified Data
This product contains cefixime (according to C16H15N5O7S2) should be 90.0% to 110.0% of the label amount.
trait
This product is a white-like tablet or film-coated tablet, white to light yellow after removing the film coating.
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 fine powder of this product, add phosphate buffer (pH 7.0) to make a solution containing about 10ug of cefixime (based on C16H15) per lml, filter, and take the filtrate, there is an absorption maximum at a wavelength of 0401 nm as determined by UV-Vis spectrophotometry (general).
examination
- appropriate amount of fine powder (about equivalent to cefixime, calculated as C16H15N507S2) under the item of content determination of related substances. lg ), put it in a 100ml measuring flask, add phosphate buffer (pH 7.0) to dissolve and dilute to the scale, shake well, filter, and take the continued filtrate as the test solution, the individual impurity peak area shall not be greater than the main peak area of the control solution (1.0% ) , and the sum of the impurity peak areas shall not be greater than 6 times (6.0%) of the main peak area of the control solution, as determined by the method under cefixime.
- the moisture content shall not exceed 0832 as determined by the method for determination of moisture content (General rule 10.0%, first method 1).
- dissolution: take 0931g of potassium dihydrogen phosphate in phosphate buffer solution (pH 7.2) and add appropriate amount of water to dissolve according to the dissolution and release determination method (General rule 6.8 method 1), adjust the pH value to 7.2 with 1 mol/L sodium hydroxide solution, dilute with water to 100 ml] as the dissolution medium, the rotation speed is rpm, and operate according to law. After 30 minutes, take the appropriate amount of solution, filter, take the appropriate amount of filtrate, dilute quantitatively with dissolution medium to prepare 10ug of cefixime (C16H15N5O7S2) per lml, measure absorbance at the wavelength of 288mn by UV-Vis spectrophotometry (General rule 0401); Take appropriate amount of cefixime reference substance by precise weighing, add dissolution medium to dissolve and quantitatively dilute to prepare a solution containing about lOug per 1 mL (if necessary, dissolve with a small amount of methanol, and the amount of methanol shall not exceed 0.1% of the total volume of the reference solution), and measure with the same method. The dissolution amount of each tablet was calculated. The limit is 80% of the labeled amount and shall be in accordance with the provisions.
- others shall be in accordance with the relevant provisions under the item of tablets (General rule 0101).
Content determination
Take 10 tablets of this product, precision weighing, fine grinding, precision weighing fine powder appropriate amount (about equivalent to cefixime, according to C16H15N507S2 50mg), put in 250ml measuring flask, add the mobile phase to dissolve and dilute to the scale, shake, filter, take the filtrate, as a test solution, according to the method under the item of cefixime.
category
Same as cefixime.
specification
0.lg (based on C16H15N507S2)
storage
shade, seal, and store in a cool place.
Last Update：2022-01-01 11:40:06
5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7-[[(2-amino-4-thiazolyl)[(carboxymethoxy)imino]acetyl]amino]-3-ethenyl-8-oxo-, [6R-[6α,7α(Z)]]- - Cefixime capsules
Authoritative Data Verified Data
This product contains cefixime (according to C16H15N5O7S2) should be 90.0% to 110.0% of the label amount.
trait
The content of this product is white to light yellow powder or granules.
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 the contents of this product, add phosphate buffer solution (pH 7.0) to make a solution containing about 10ug of cefixime (based on C16H15N5O7S2) per LML, filter, and take the filtrate, there is an absorption maximum at a wavelength of 0401 nm as determined by UV-Vis spectrophotometry (general).
examination
- the appropriate amount of the content under the difference in the amount of related substances (about 0.lg equivalent to cefixime, based on C16H15N5O7S2), put it in a 100ml measuring flask, and add phosphate buffer (pH 7.0) dissolve and dilute to the scale, shake, filter, take the filtrate as a test solution; According to the method under the item of cefixime, the 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 6 times (6.0%) of the main peak area of the control solution.
- moisture the contents of this product shall not contain more than 0832 of moisture as determined by the method for moisture determination (General rule 12.0%, first method 1).
- dissolution: take 0931g of potassium dihydrogen phosphate in phosphate buffer solution (pH 7.2) and add appropriate amount of water to dissolve according to the dissolution and release determination method (General rule 6.8 first method), adjust the pH value to 7.2 with 1 mol/L sodium hydroxide solution, dilute with water to 100 ml) as the dissolution medium, the rotation speed is rpm, and operate according to law. After 30 minutes, take the appropriate amount of the solution, filter, take the appropriate amount of the filtrate, and dilute it quantitatively with the dissolution medium to prepare a solution containing about l0ug of cefixime (based on C16H15N5O7S2) per lml, according to UV-visible spectrophotometry (General rule 0401), the absorbance was measured at the wavelength of 288nm; The appropriate amount of cefixime control was accurately weighed, add dissolution medium to dissolve and quantitatively dilute to prepare a solution containing about 10ug per lml (if necessary, dissolve with a small amount of methanol, the amount of methanol shall not exceed 0.1% of the total volume of the reference solution), and determine with the same method. The amount of dissolution of each pellet was calculated. The limit is 80% of the labeled amount and shall be in accordance with the provisions.
- others should comply with the relevant provisions under the capsule (General 0103).
Content determination
take the appropriate amount of the content under the difference of loading (about 50mg equivalent to cefixime, as measured by C16H15N507S2), weigh it accurately, put it in a 250ml measuring flask, add the mobile phase to dissolve and dilute to the scale, shake, filter, take the filtrate, as a test solution, according to the method under the item of cefixime, then obtained.
category
Same as cefixime.
specification
Based on C16H15N5O7S2 (l)50mg (2)l00mg
storage
shade, seal, and store in a cool place.
Last Update：2022-01-01 11:40:07
5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7-[[(2-amino-4-thiazolyl)[(carboxymethoxy)imino]acetyl]amino]-3-ethenyl-8-oxo-, [6R-[6α,7α(Z)]]- - Cefixime granules
Authoritative Data Verified Data
This product contains cefixime (according to C16H15N5O7S2) should be 90.0% to 110.0% of the label amount.
trait
This product is suspended particles.
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 this product, add phosphate buffer (pH 7.0) to dissolve and dilute to prepare a solution containing about 10ug cefixime (based on C16H15N507S2) per LML, filter, and take the filtrate, there is an absorption maximum at a wavelength of 0401 nm as determined by UV-Vis spectrophotometry (general).
examination
- acidity: take this product, add water to make a suspension containing 1 mg of cefixime (based on C16H15N5O7S2) per 1 ml, and determine it according to law (General rule 0631). The pH value should be 2.5~4.5.
- the appropriate amount of the content under the difference in the amount of related substances (about 0.1g equivalent to cefixime, based on C16H15N5O7S2), put it in a 100ml measuring flask, and add phosphate buffer solution (pH7.0). Dissolve and dilute to the scale, shake, filter, take the filtrate as a test solution; According to the method under the cefixime determination. The 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 6 times (6.0%) of the main peak area of the control solution.
- the moisture content of this product shall not exceed 0832 as determined by the method for determination of moisture (General rule 2.0%, first method 1).
- dissolution dissolution of this product, according to the dissolution and release determination method (General 0931 second method), phosphate buffer (pH 7.2) (take potassium dihydrogen phosphate 6.8g, add the appropriate amount of water to dissolve, adjust the pH value to 7.2 with 1 mol / L sodium hydroxide solution, dilute with water to ML) as the dissolution medium, the rotation speed is 50 revolutions per minute, and operate according to law. After 30 minutes, take the appropriate amount of solution, filter, take the appropriate amount of filtrate, add the appropriate amount of dissolution medium, and make the solution containing about l0ug of cefixime (based on C16H15N5O7S2) per lml, according to UV-visible spectrophotometry (General rule 0401), the absorbance was measured at the wavelength of 288nm; The appropriate amount of cefixime control was accurately weighed, add dissolution medium to dissolve and quantitatively dilute to prepare a solution containing about 10ug per lml (if necessary, dissolve with a small amount of methanol, the amount of methanol shall not exceed 0.1% of the total volume of the reference solution), and determine with the same method. The amount of dissolution per pack was calculated. The limit is 80% of the labeled amount and shall be in accordance with the provisions.
- others should comply with the relevant provisions under The granule (General Principle 0104).
Content determination
take an appropriate amount of the content (about 50mg equivalent to cefixime as measured by C16H15N507S2) under the difference of loading amount, put it in a 250ml measuring flask, add the mobile phase to dissolve and dilute to the scale, shake well, the filtrate was collected by filtration and obtained as a test solution by measurement according to the method described in the section of cefixime.
category
Same as cefixime.
specification
50mg (based on C16H15N5O7S2)
storage
shade, seal, and store in a cool place.
Last Update：2022-01-01 11:40:08
![5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7-[[(2-amino-4-thiazolyl)[(carboxymethoxy)imino]acetyl]amino]-3-ethenyl-8-oxo-, [6R-[6α,7α(Z)]]-](http://res.chembk.com/assets/images/structure/C242800.png)
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Product Name: Cefixime Request for quotation
CAS: 79350-37-1/108691-83-4
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Email: pules.cn@gmail.com
Mobile: +86-17551318830
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CAS: 79350-37-1/108691-83-4
Tel: 17505222756
Email: pules.cn@gmail.com
Mobile: +86-17551318830
Wechat: 17505222756
Multiple SpecificationsSpot supply
Product Name: Cefixime Impurity 1（Cefixime EP Impurity C） Visit Supplier Webpage Request for quotationCAS: 108691-83-4
Tel: 0714-3999186
Email: 2853786052@qq.com
Mobile: 86+15671228036
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Product Name: Cefixime Request for quotation
CAS: 79350-37-1
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Mobile: 0086 189 4982 3763
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CAS: 79350-37-1
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