disodium (6r,7r)-7-[[(2r)-2-hydroxy-2-phenyl-acetyl]amino]-8-oxo-3-[[1-(sulfonatomethyl)tetrazol-5-yl]sulfanylmethyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate
Cefonicid sodium
CAS: 61270-78-8
Molecular Formula: C18H16N6Na2O8S3
disodium (6r,7r)-7-[[(2r)-2-hydroxy-2-phenyl-acetyl]amino]-8-oxo-3-[[1-(sulfonatomethyl)tetrazol-5-yl]sulfanylmethyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate - Names and Identifiers
disodium (6r,7r)-7-[[(2r)-2-hydroxy-2-phenyl-acetyl]amino]-8-oxo-3-[[1-(sulfonatomethyl)tetrazol-5-yl]sulfanylmethyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate - Physico-chemical Properties
| Molecular Formula | C18H16N6Na2O8S3 |
| Molar Mass | 586.53 |
| Melting Point | > 160°C |
| Solubility | DMSO (Slightly), Methanol (Slightly) |
| Appearance | Solid |
| Color | White to Pale Yellow |
| Storage Condition | Inert atmosphere,2-8°C |
| Use | Second-generation cephalosporins for Gram-positive and partial Gram-negative infections |
disodium (6r,7r)-7-[[(2r)-2-hydroxy-2-phenyl-acetyl]amino]-8-oxo-3-[[1-(sulfonatomethyl)tetrazol-5-yl]sulfanylmethyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate - Risk and Safety
| HS Code | 2941906000 |
disodium (6r,7r)-7-[[(2r)-2-hydroxy-2-phenyl-acetyl]amino]-8-oxo-3-[[1-(sulfonatomethyl)tetrazol-5-yl]sulfanylmethyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate - Nature
Open Data Verified Data
dissolved in ethyl acetate.
cefonicid sodium (ce-fonicid dexodiitun salt):CAS accession number [61270-78-8]Last Update：2024-01-02 23:10:35
disodium (6r,7r)-7-[[(2r)-2-hydroxy-2-phenyl-acetyl]amino]-8-oxo-3-[[1-(sulfonatomethyl)tetrazol-5-yl]sulfanylmethyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate - Quality standards-Chinese Pharmacopoeia 2005 edition
Open Data Verified Data
cefonicid sodium; Cefonicid containing not less than 832trg and not more than 970tig per 1mg calculated as anhydrous (Ci8 Hi8 N6 08 s3); the content of cefonicid per 1mg is not more than 0. 35 of the USP Endotoxin lpH value should be 3.5~6.5(1mg of the product dissolved in 20ml of water); Containing water should not be greater than so%.
Last Update：2022-01-01 08:52:30
disodium (6r,7r)-7-[[(2r)-2-hydroxy-2-phenyl-acetyl]amino]-8-oxo-3-[[1-(sulfonatomethyl)tetrazol-5-yl]sulfanylmethyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate - Standard
Authoritative Data Verified Data
This product is (6R,7R)-7-[(R)-Α-hydroxyphenylacetamido] -8-oxo-3-[[l-sulfonic acid methyl -1H-tetrazol-5-yl] Thio] methyl]-5-thiol -1-azabicyclo [4.2.0] oct-2-ene-2-carboxylic acid disodium salt. Calculated as anhydrous, containing cefonicid (C18H18N608S3) should be 83.2% ~ 97.0%.
Last Update：2024-01-02 23:10:35
disodium (6r,7r)-7-[[(2r)-2-hydroxy-2-phenyl-acetyl]amino]-8-oxo-3-[[1-(sulfonatomethyl)tetrazol-5-yl]sulfanylmethyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate - Trait
Authoritative Data Verified Data
- This product is white or off-white powder or crystalline powder.
- This product is easily soluble in water, easily soluble in methanol, very slightly soluble in ethanol, almost insoluble in ether.
specific rotation
take this product, precision weighing, add methanol 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 -37 ° to -47 °.
Last Update：2022-01-01 11:39:35
disodium (6r,7r)-7-[[(2r)-2-hydroxy-2-phenyl-acetyl]amino]-8-oxo-3-[[1-(sulfonatomethyl)tetrazol-5-yl]sulfanylmethyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate - Preparation solution concentration reference
| 1mg | 5mg | 10mg | |
|---|---|---|---|
| 1 mM | 1.705 ml | 8.525 ml | 17.049 ml |
| 5 mM | 0.341 ml | 1.705 ml | 3.41 ml |
| 10 mM | 0.17 ml | 0.852 ml | 1.705 ml |
| 5 mM | 0.034 ml | 0.17 ml | 0.341 ml |
Last Update：2024-01-02 23:10:35
disodium (6r,7r)-7-[[(2r)-2-hydroxy-2-phenyl-acetyl]amino]-8-oxo-3-[[1-(sulfonatomethyl)tetrazol-5-yl]sulfanylmethyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate - Preparation Method
Open Data Verified Data
potassium hydroxide and aminomethanesulfonic acid were dissolved in water and carbon disulfide was added. After stirring, ethanol was added, followed by methyl iodide. After completion of the reaction, a solid was obtained by cooling and filtration. The solid was extracted with hot methanol, and the extract was concentrated to obtain a potassium salt of methyl N-sulfomethyldithiocarbamate. The obtained potassium salt of methyl N-sulphomethyldithiocarbamate and sodium azide were dissolved in water and heated at 80 °c for 4.75 H. The reaction solution was passed through an ion exchange resin column and was developed with water until the pH of the effluent reached 3.5. The effluent was extracted with diethyl ether and concentrated to dryness to give 1 sulfomethyl tetrazole-5-thiol. The thiol was dissolved in acetone, a solution of 30% sodium 2-ethylhexanoate in isopropanol was added, and the precipitate precipitated by filtration was the sodium salt of 1 sulfomethyl tetrazole-5-thiol.
The sodium salt of 7-amyloylaminocephalosporanic acid, 1-sulfomethyl tetrazole-5-thiol and sodium bicarbonate were dissolved in water, and th was heated at 70 °c. With ice bath cooling, with 3molll hydrochloric acid to pH 1.8. It was then extracted with ethyl acetate and filtered. The filtrate is subjected to column chromatography, and the developing solution is water containing methanol, and the content of methanol is continuously increased with the continuous development, and the cefonicid can be obtained. Cefonicid was dissolved in methanol and a 5% solution of sodium methoxide in methanol was added to pH = 7.0. Ethanol was then added to produce a precipitate. The precipitate was collected by filtration and dissolved in water to obtain the disodium salt of cefonicid after lyophilization.
Last Update：2022-01-01 08:52:30
disodium (6r,7r)-7-[[(2r)-2-hydroxy-2-phenyl-acetyl]amino]-8-oxo-3-[[1-(sulfonatomethyl)tetrazol-5-yl]sulfanylmethyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate - 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 control (Spectrum set 1121).
- This product shows the reaction of sodium salt identification (1) (General rule 0301).
Last Update：2022-01-01 11:39:35
disodium (6r,7r)-7-[[(2r)-2-hydroxy-2-phenyl-acetyl]amino]-8-oxo-3-[[1-(sulfonatomethyl)tetrazol-5-yl]sulfanylmethyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate - Use
Open Data Verified Data
The British GlaxoSmithKline company R & D, in 1984 to Monocid trade name in the United States, has been listed in Belgium, Spain, etc., for the treatment of sepsis, joint, skin, lower respiratory tract and urinary tract infections. Cefonicid sodium is a second-generation cephalosporin, which has antibacterial effect on most Gram-positive cocci, and has a wider antibacterial spectrum on Gram-negative bacilli than the first-generation cephalosporin, pneumonia Bacillus, Proteus mirabilis and so on have strong antibacterial effect. For urinary tract infections caused by sensitive bacteria, skin and soft tissue infections, respiratory infections, bone infections, gonorrhea.
Last Update：2022-01-01 08:52:30
disodium (6r,7r)-7-[[(2r)-2-hydroxy-2-phenyl-acetyl]amino]-8-oxo-3-[[1-(sulfonatomethyl)tetrazol-5-yl]sulfanylmethyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate - Exam
Authoritative Data Verified Data
acidity
take this product, add water to make a solution containing 50mg per lml, according to the law (General 0631),pH value should be 3.5~6.5.
clarity of the solution
take 5 parts of this product, each 0.6g, respectively, add water 5ml to dissolve, immediately check according to law, the solution should be clear; If it is turbid, and 1 turbidity standard solution (General rule 0902 first method) in comparison, they should not be more concentrated.
absorbance
take an appropriate amount of this product, add water to dissolve and quantitatively dilute to make each lml containing cefonicid O.lg of the solution, according to UV-visible spectrophotometry (General rule 0401), at the wavelength of 0.10 nm, the absorbance should not exceed.
Related substances
take an appropriate amount of this product, add the mobile phase to dissolve and dilute to make a solution containing about 0.5mg 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 each of the test solution and the control solution are accurately measured and injected into the human liquid chromatograph respectively, and the chromatogram is recorded to 5 times of the retention time of the main component peak. If there are impurity peaks in the chromatogram of the test solution, the peak area of 7-aminocephalosporanic acid (7-ACA) shall not be more than 0.5 times (0.5%) of the main peak area of the control solution; the Peak area of 5-mercaptosulfonic Acid Methyl Tetrazole (3-TSA) shall not be more than 2 times (2.0%) the main peak area of the control solution; The peak area of other individual impurities shall not be more than the main peak area of the control solution (1.0% ) , the sum of each impurity peak area shall not be greater than 5 times (5.0%) of the main peak area of the control solution.
cefonicid polymer
measured by size exclusion chromatography (General 0514).
chromatographic conditions and system suitability test
using dextran gel G-10(40 to um) as a filler, the inner diameter of the glass column was 1.0 to 1.4, and the column length was 30 to 40. Mobile phase A was 0 at pH 7.0.1 mol/L phosphate buffer [O. 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 1.2ml per minute, and the detection wavelength was 254mn. Take 2000 ~ 200ul of 100 Blue dextran solution (0.1mg/ml) and inject it into human Liquid Chromatograph. Determine with mobile phase A and B respectively, and record chromatogram, the theoretical plate number is not less than 2000 when the Blue dextran 500 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 time 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 chromatographic system should be between 0.93 and 1.07. Weigh about 0.2g of cefonicid sodium, put it in a 10ml measuring flask, dissolve it in 2000 mg/ml of Blue dextran solution, dilute it to the scale, and shake it well. Take 100~200u1 injection liquid chromatograph, with mobile phase A for measurement, 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. In addition, the mobile phase B is used as the mobile phase, and the relative standard deviation of the peak area should not be more than 100 when the control solution is 200-5.0% u1 for 5 consecutive injections.
preparation of control solution
an appropriate amount of cefonicid reference substance was accurately weighed, dissolved with water and quantitatively diluted to prepare a solution containing 0.1 mg per 1 ml.
assay
take about 0.2g of this product, accurately weigh it, put it in a 10ml measuring flask, add water to dissolve and dilute to the scale, shake well, immediately take 100 ~ 200ul accurately, and inject it into the liquid chromatograph, the mobile phase A was used as the mobile phase, and the chromatogram was recorded. In addition, 100~20 ou1 of the control solution was accurately weighed and injected into the human Liquid Chromatograph. The mobile phase B was used as the mobile phase, and the same method was used for determination. The amount of polymer containing cefonicid shall not exceed 0.4% calculated by the area of cefonicid peak according to the external standard method.
residual solvent
take this product l.Og, precision weighing, in the top empty bottle, precision add water 5ml to dissolve, sealed, as a test solution; Another precision weighing methanol, ethanol, acetonitrile, acetone, ethyl acetate, each appropriate amount of tetrahydrofuran and dichloromethane was Diluted quantitatively with water to prepare solutions containing 0.6mg of methanol, 1.0 mg of ethanol, 0.082mg of acetonitrile, 1.0 mg of acetone, 1.0 mg of ethyl acetate, 0.144mg of Tetrahydropyran and 0.12mg of dichloromethane per 1 ml, respectively, 5ml was accurately measured, placed in a top empty bottle, sealed, and used as a reference solution. According to the determination method of residual solvent (General 0861 second method), the capillary column with 100% dimethyl polysiloxane (or similar polarity) as stationary liquid is used as the column, the initial temperature is 45°C, and the retention time is 5 minutes, the temperature was then increased to 180°C at a rate of 10°C per minute; The inlet temperature was 150°C; The detector temperature was 200°C; The headspace bottle equilibrium temperature was 90°C, and the equilibrium time was 20 minutes. Take the reference solution into the headspace, the separation degree between the peaks should meet the requirements. The reference solution and the test solution were injected in Headspace respectively, and the chromatogram was recorded. According to the external standard method to calculate the peak area, methanol, ethanol, acetonitrile, acetone, ethyl acetate, tetrahydrofuran and dichloromethane residues should be in accordance with the provisions.
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 2g, plus particle inspection water dissolution, inspection according to law (General 0904), should comply with the provisions. (For sterile packaging) insoluble particles take 3 parts of this product, and make a solution containing 40mg per 1 ml of water for particle inspection, 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 more than 25um. (For aseptic dispensing)
bacterial endotoxin
take this product, check according to law (General 1143), the amount of endotoxin per 1 mg of cefonicid should be less than 0.35EU (for injection)
sterile
take this product, dissolve and dilute with 0.9% sterile sodium chloride solution to prepare a solution containing 60mg per 1 ml, and treat it by membrane filtration, wash with 0.1% sterile peptone solution (not less than 600ml per membrane), add not less than 6 million units of penicillinase per tube of culture medium, with Staphylococcus aureus as positive control bacteria, inspection in accordance with the law (General rule 1101), should comply with the provisions. (For aseptic dispensing)
Last Update：2022-01-01 11:39:36
disodium (6r,7r)-7-[[(2r)-2-hydroxy-2-phenyl-acetyl]amino]-8-oxo-3-[[1-(sulfonatomethyl)tetrazol-5-yl]sulfanylmethyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate - Content determination
Authoritative Data Verified Data
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
silica gel bonded with octanoalkyl silane was used as the filler; 0.02mol/L ammonium dihydrogen phosphate solution (adjusted to pH 7.0 with ammonia solution)-methanol (84:16) as the mobile phase, the detection wavelength was 272mn. Take an appropriate amount of cefonicid reference, add mobile phase to analyze and dilute to make a solution containing 0.2mg per 1 ml, place it in a 70°C water bath for 40 minutes, and let it cool, then use it as reference solution (1 ), in addition, the appropriate amount of impurity reference substance 7-aminocephalosporanic acid (7-acak5-mercapto-1-sulfonated methyl tetrazolium (3-TSA)) was weighed, and the reference solution (1) was added. Dissolve and dilute to make each about 0.lmg mixed solution, take 20ul injection liquid chromatograph, record chromatogram, peak order: 5-mercapto-1-sulphonated methyl Tetrazole (3-TSA), 7-aminocephalosporanic acid (7-ACA), cefonicid, deacetylcefonicid. The degree of separation between peaks shall meet the requirements.
assay
take an appropriate amount of this product, precision weighing, and add the mobile phase to dissolve and quantitatively dilute to prepare a solution containing about 0.2mg of cefonicid per 1 ml as a test solution, accurate injection of human liquid chromatography, record chromatogram; Another accurate weighing cefonicid standard appropriate amount, the same method for determination. The content of cefonicid (C18H18N603S3) in the sample was calculated by the peak area according to the external standard method.
Last Update：2022-01-01 11:39:37
disodium (6r,7r)-7-[[(2r)-2-hydroxy-2-phenyl-acetyl]amino]-8-oxo-3-[[1-(sulfonatomethyl)tetrazol-5-yl]sulfanylmethyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate - Category
Authoritative Data Verified Data
B-lactam antibiotics, cephalosporins.
Last Update：2022-01-01 11:39:38
disodium (6r,7r)-7-[[(2r)-2-hydroxy-2-phenyl-acetyl]amino]-8-oxo-3-[[1-(sulfonatomethyl)tetrazol-5-yl]sulfanylmethyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate - Storage
Authoritative Data Verified Data
sealed and stored in a cool and dry place.
Last Update：2022-01-01 11:39:38
disodium (6r,7r)-7-[[(2r)-2-hydroxy-2-phenyl-acetyl]amino]-8-oxo-3-[[1-(sulfonatomethyl)tetrazol-5-yl]sulfanylmethyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate - Cefonicid sodium for injection
Authoritative Data Verified Data
This product is a sterile powder of cefonicid sodium. Calculated as anhydrous, containing cefonicid (C18H18N608S3) shall be 97.0% ~ 90.0%; Calculated as the average loading, containing cefonicid (C18H18N608S3) shall be 110.0% ~ of the labeled amount.
trait
This product is white or off-white powder or crystalline powder.
identification
According to the identification test under the item of cefonicid sodium, the same result was shown.
examination
- clarity of solution take 5 bottles of this product, and add water separately according to the labeled amount to make 0 per 1 ml. lg's solution should be checked immediately according to law, and the solution should be clarified; If it is turbid, it should not be more concentrated than the No. 1 turbidity standard solution (General 0902 first method).
- absorbance: take 5 bottles of this product, add water to dissolve and quantitatively dilute it according to the indicated amount, and make it contain 0 per lml. lg of the solution, according to UV-visible spectrophotometry (General rule 0401), at the wavelength of 0.10 nm, the absorbance should not exceed.
- insoluble particles take this product, according to the label, add particles to check water to make a solution containing 40mg per 1 ml, and check according to law (General rule 0903), the label amount is l. The conversion below Og is per l. No more than 6000 particles with lOum and more than 10um and no more than 600 particles with lOum and more than 25um in the 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. Acidity, related substances, cefonicid polymer, moisture, bacterial endotoxin and sterility shall be checked according to the method under cefonicid sodium.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
The contents under the item of loading amount difference were obtained by measuring according to the method under the item of cefonicid sodium.
category
Same as cefonicid sodium.
specification
Based on C18H18N608S3 (l)0.5g (2)1.0g (3)2.0g
storage
sealed and stored in a cool and dry place.
Last Update：2022-01-01 11:39:39
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Product Name: Cefonicid sodium Request for quotation
CAS: 61270-78-8
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CAS: 61270-78-8
Tel: 17505222756
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