cefotaxim sodium salt
cefotaxim sodium salt
CAS: 64485-93-4
Molecular Formula: C16H16N5NaO7S2
cefotaxim sodium salt - Names and Identifiers
cefotaxim sodium salt - Physico-chemical Properties
| Molecular Formula | C16H16N5NaO7S2 |
| Molar Mass | 477.45 |
| Melting Point | 162-163 C |
| Specific Rotation(α) | D20 +55±2° (c = 0.8 in water) |
| Water Solubility | Soluble in water. |
| Solubility | Easily soluble in water, slightly soluble in ethanol, insoluble in chloroform. |
| Appearance | crystalline solid (white to light yellow crystalline powder) |
| Color | white to yellow |
| Merck | 14,1933 |
| BRN | 5711411 |
| PH | pH(100g/l, 25℃) : 4.5～6.5 |
| Storage Condition | Keep in dark place,Inert atmosphere,2-8°C |
| Stability | Stable. Incompatible with strong oxidizing agents. |
| Refractive Index | 61 ° (C=1, H2O) |
| MDL | MFCD00079073 |
| Physical and Chemical Properties | White, white or yellowish white crystals, odorless or slightly special odor. Soluble in water, ethanol-soluble, insoluble in chloroform. The dilute solution is colorless or yellowish, gray-yellow when the concentration is high, dark yellow or brown when it is qualitative. Melting point 162~163 °c (decomposition). [Α] D20 56 ° ~ 64 °(10mg of this product is dissolved in 1 ml water):[α] D20> 55 ° ± 2 °(C = 0.8, water). |
| Use | Mainly used for the treatment of respiratory system, urinary system, intestinal tract and biliary tract, skin and soft tissue, Burns and bone and joint infections caused by sensitive bacteria |
cefotaxim sodium salt - Risk and Safety
| 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. S60 - This material and its container must be disposed of as hazardous waste. S45 - In case of accident or if you feel unwell, seek medical advice immediately (show the label whenever possible.) S37 - Wear suitable gloves. S24 - Avoid contact with skin. |
| WGK Germany | 2 |
| RTECS | XI0250000 |
| HS Code | 29419000 |
cefotaxim sodium salt - Upstream Downstream Industry
| Raw Materials | N,N-Dimethylformamide N,N-Dimethylformamide N,N-Dimethylformamide 2-(2-Aminothiazole-4-yl)-2-methoxyiminoacetic acid Acetone Acetone Methyl alcohol Methyl alcohol Ethyl Alcohol 1-Butanol |
cefotaxim sodium salt - Reference
| Reference Show more | 1. Liu Minxuan, Zhao Xingran, Yu Lu, etc. Rapid detection of cefalexin residues in animal derived food by colloidal gold strip. 2. Qi Xiangjun, Liu Yao. Induction and culture conditions of hairy roots of Sophora flavescens [J]. Journal of Anhui Agricultural Sciences, 2012, 23 (16):8823-8824. 3. Small body Yang, Xiaoyan Tang, Xiaoqing Zhang, etc. Determination of cefotaxime and its main metabolites in chicken plasma by ultra performance liquid chromatography-tandem mass spectrometry [J]. Food Science, 2017, 29 (22):317-321. 4. Small body Yang, Xiaoyan Tang, Xi Shen, et al. Simultaneous determination of cefotaxime and its main metabolites in eggs by high performance liquid chromatography-tandem mass spectrometry [J]. Analytical Chemistry, 2017(7). 5. Yue Jiajuan, Liu Jian, Gong Jiashun. Effect of pu-erh tea brown pigment on intestinal flora of rats [J]. Tea Science, 2016, 36(3):261-267. 6. Li, Chongyang, et al. Application of prevention in Prediction Models of Raman Spectra." 2013 5th International Conference on Intelligent Human-Machine Systems and Cybernetics. Vol. 2. IEEE, 2013.https://doi.org/10.1109/IHMSC.2013.262 |
cefotaxim sodium salt - Nature
Open Data Verified Data
white, off-white or yellowish white crystals, odorless or slightly special odor. Melting point 163~163 °c (decomposition). Soluble in water, ethanol-soluble, insoluble in chloroform. The dilute solution is colorless or yellowish, gray-yellow when the concentration is high, dark yellow or brown when it is qualitative.
Last Update：2025-06-10 22:55:16
cefotaxim sodium salt - Quality standards-Chinese Pharmacopoeia 2005 edition
Open Data Verified Data
The content of cefotaxime (C16 H17 Ns 07 S2) shall not be less than 86.0% calculated as anhydrous; The pH value shall be 4.5~6.5(0. lg the product is soluble in 1 ml of water); Water should not pass 6. 0%; Bacterial endotoxin, Img the product is less than 0.05EU; Sterility should be met.
Last Update：2025-06-10 22:55:16
cefotaxim sodium salt - Standard
Authoritative Data Verified Data
This product is (6R,7R)-3-[(Acetoxy) methyl]-7-[2-(2-aminothiazol-4-yl)-2-(methoxyimino) acetamido]-8-oxo-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylic acid sodium salt. Containing no less than 90.0% of cefotaxime (C16H17N507S2), calculated as anhydrous.
Last Update：2024-01-02 23:10:35
cefotaxim sodium salt - Trait
Authoritative Data Verified Data
- This product is white to yellowish crystal or powder; Odorless or slightly special odor.
- This product is soluble in water, slightly soluble in ethanol.
specific rotation
take this product, precision weighing, adding water to dissolve and quantitatively dilute the solution containing about 10mg per lml, according to the law (General 0621), the specific rotation of 58 degrees to 64.
absorption coefficient
take about 20mg of this product, precision weighing, adding water to dissolve and quantitatively dilute to make a solution containing about 20ug per lml, according to UV-Vis spectrophotometry (General 0401), the absorbance was measured at a wavelength of 235nm, and the absorption coefficient was 360 to 390.
Last Update：2022-01-01 11:41:55
cefotaxim sodium salt - Preparation Method
Open Data Verified Data
first, 7-ACA (7-aminocephalosporanic acid) was used as a raw material, and triethylamine was dissolved in dichloromethane. Phosphorus pentachloride was added under cooling in an ice bath. Thereafter, the mixture was stirred at room temperature. The mixture was concentrated under reduced pressure, and n-hexane was added thereto for vigorous stirring. Removal of the n-hexane gave a precipitated oil, which was dissolved in tetrahydrofuran. The precipitated triacetonitrile hydrochloride was removed by filtration to obtain a tetrahydrofuran solution of the intermediate compound. 7-ACA and triethylamine were dissolved in a 50% aqueous solution of tetrahydrofuran, a solution of the intermediate compound in tetrahydrofuran was added dropwise under cooling in an ice bath, and th was stirred at room temperature. Water and ethyl acetate were added and the aqueous layer was adjusted to pH 2.0 with phosphoric acid. After shaking, the organic layer was separated and the aqueous layer was extracted with ethyl acetate. After the treatment, the compound can be obtained in powder form. The powdery compound was dissolved in dimethylhexanamide, thiourea was added and stirred for 15 h at room temperature. Adjust to pH = 3.5 with sodium bicarbonate. The precipitated solid was collected by filtration, dissolved in 5% aqueous sodium bicarbonate solution, and further treated to give cefotaxime sodium as a colorless powder. The obtained cefotaxime sodium was dissolved in distilled water to form a solution, which was added to an ethanol solution of sodium bicarbonate, and then ethanol and activated carbon were added, stirred and filtered. The filter cake was washed with ethanol, the filtrate was concentrated to dryness under reduced pressure, and the procedure was repeated. The resulting material was dissolved in methanol and placed in acetone. The resulting solution was vigorously stirred and filtered under reduced pressure. The solid was washed with acetone followed by a slight addition of ether and dried under vacuum to give white cefotaxime sodium.
Last Update：2025-06-10 22:55:16
cefotaxim sodium salt - 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 130).
- This product shows the reaction of sodium salt identification (1) (General rule 0301).
Last Update：2022-01-01 11:41:55
cefotaxim sodium salt - Application
Open Data Verified Data
The third generation of broad-spectrum cephalosporin antibiotics, more broad spectrum than cefuroxime, gram-negative bacteria and positive bacteria have a strong bactericidal effect, in particular, the effect of gram-negative bacteria is strong, and the drug must be injected. Antimicrobial Spectrum includes haemophilic influenza, Escherichia coli, salmonella, Klebsiella and Proteus mirabilis, Neisseria, Staphylococcus, Pneumonia cocci, Streptococcus, etc. Clinical use of sensitive bacteria caused by respiratory infections, urinary tract infections, biliary tract and intestinal infections, skin and soft tissue infections, sepsis, Burns and bone and joint infections.
Last Update：2025-08-19 16:24:40
cefotaxim sodium salt - Exam
Authoritative Data Verified Data
acidity
take this product, add water to make a solution containing about 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 l. After 10ml of water is added to the solution, the solution should be clear and colorless; If it is turbid, it should not be more concentrated compared with No. 1 turbidity standard solution (General rule 0902 first method). Take 10ml of the above solution, add 1ml of glacial acetic acid, shake well, immediately check, the solution should be clear; If it is turbid, it should not be more concentrated compared with No. 1 turbidity standard solution (General rule 0902 method 1). In case of color development, it shall not be deeper in comparison with the yellow or yellow-green or orange-yellow Standard Colorimetric solution No. 6 (General rule 0901 method 1).
Related substances
take an appropriate amount of this product, precision weighing, and add mobile phase A to dissolve and quantitatively dilute to prepare A solution containing lmg per lml, as A test solution (ready to use new system); an appropriate amount of cefotaxime reference substance was added, and the mobile phase A was added to dissolve and quantitatively dilute to prepare A solution containing 10ug per 1 ml as A control solution. According to the determination of high performance liquid chromatography (General 0512), using eighteen alkyl silane bonded silica gel as filler; Mobile phase A was 0.05mol/L phosphate buffer (take 7.1g of disodium hydrogen phosphate anhydrous into 1000ml measuring flask, add water to dissolve and dilute to the scale, adjust the pH value with phosphoric acid to 6.25)-methanol (86:14); the mobile phase B was 0.05mol/L phosphate buffer (pH 6.25)-methanol (60:40); The detection wavelength was 235nm. First, the mobile phase A- mobile phase B(95:5) isocratic elution, immediately after the completion of the cefotaxime peak elution, linear gradient elution was carried out according to the following table. Take the system applicable solution LOL under the content determination item and inject it into the liquid chromatograph. The chromatogram recorded shall be consistent with the standard chromatogram. l0ul of the test solution and the control solution are respectively injected into the liquid chromatograph to record the chromatogram. If there are impurity peaks in the chromatogram of the test solution, 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 3 times (3.0%) of the main peak area of the control solution, the peaks in the chromatogram of the test solution which were 0.05 times smaller than the main peak area of the control solution were ignored.
cefotaxime 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 glass column has an inner diameter of 1.0 to 1.4 and a column length of 30 to 40. At pH 7.0 0.lmol/L phosphate buffer [0.1 mol/L disodium hydrogen phosphate solution -0.1 mol/L sodium dihydrogen phosphate solution (61:39)] as mobile phase A, water as mobile Phase B, the flow rate was about 1.5ml per minute, the detection wavelength was 254nm. Take 1.0~2000 u1 of 100 mg/ml Blue dextran 200 solution and inject it into human liquid chromatograph, using mobile phase A and B as mobile phase respectively, record chromatogram, the number of theoretical plates is not less than 2000 calculated by the Blue dextran 500 peak, 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 chromatography system should be between 0.93 and 1.07. Take about 0.2g of cefotaxime sodium and put it in a 10ml measuring flask, add 2000 of Blue dextran solution of 1.0 mg/ml to dissolve and dilute to the scale, shake well. 100~200u1 was injected into the liquid chromatograph, and the measurement was performed with the mobile phase A, and the chromatogram was recorded. The ratio of the peak height of the polymer to the valley height between the monomer and the 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
About 25mg of the cefotaxime control was precisely weighed, dissolved with water and quantitatively diluted to make a solution containing about 100ug 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 100~200u1 and inject it into human liquid chromatograph, the mobile phase A was used as the mobile phase, and the chromatogram was recorded. In addition, 100~200u1 of the control solution was injected into the human liquid chromatograph, and the mobile phase B was used as the mobile phase, and the same method was used for measurement. The amount of polymer containing cefotaxime shall not exceed 0.5% calculated by the peak area of cefotaxime according to the external standard method.
residual solvent
take this product about 1.Og, precision weighing, put it in 10ml measuring flask, add internal standard solution (weigh the appropriate amount of methyl ethyl ketone, dissolve it with water and dilute it into a solution containing about 200ug per lml) dissolve and dilute to the scale, as a stock solution for the test sample; Take the sample stock solution and the internal standard solution of each lml in the same headspace bottle, sealed, as a test solution. Accurately weigh appropriate amount of each solvent, and quantitatively dilute with internal standard solution to make methanol 0.3mg per lml, ethanol, acetone, isopropanol, ethyl acetate 0.5mg each, the mixed solution of dichloromethane 60ug and tetrahydrofuran 70ug, take the mixed solution and the sample stock solution with precision 1.0 ML was placed in the same headspace bottle, sealed, and used as a control solution. Determined according to the residual solvent assay (General 0861 first method). The capillary column with 100% dimethyl polysiloxane (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 carrier gas was nitrogen or helium, and the equilibrium temperature of the headspace bottle was 70°C, and the equilibrium time was 30 minutes. Take the reference solution into the headspace, the separation degree between the peaks should meet the requirements. The test solution and the reference solution were injected into the headspace, and the chromatogram was recorded. The peak area was calculated according to the standard addition method. Methanol, ethanol, acetone, isopropanol, ethyl acetate, dichloromethane and tetrahydrofuran residues shall be in accordance with the provisions.
moisture
take this product, according to the moisture determination method (General 0832 first method 1), the water content shall not exceed 3.0%.
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 aseptic dispensing)
insoluble particles
Take 3 parts of this product, and make a solution containing 50mg per lml of water for particle inspection, and check it according to law (General rule 0903). In each lg sample, no more than 6000 particles containing 10um and more than lOum, and no more than 600 particles containing 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 cefotaxime should be less than 0.050EU. (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 11:41:56
cefotaxim sodium salt - 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 as a filler; 0.O5mol/L phosphate buffer (7.1g of disodium hydrogen phosphate was added to a 1000ml measuring flask, dissolved in water and diluted to the scale, and the pH value was adjusted to 6.25 with phosphoric acid)-methanol (85:15) as mobile phase; The detection wavelength was 235nm. Take appropriate amount of cefotaxime system applicable reference, add mobile phase to dissolve and dilute to make a solution containing about 1 mg per 1 ml, as the system applicable solution, take 10u1 injection liquid chromatograph, the recorded chromatograms should be consistent with the standard chromatograms.
assay
take an appropriate amount of this product, accurately weigh it, add mobile phase to dissolve and quantitatively dilute to make a solution containing about lmg per lml, as a sample solution, and inject l0ul into the liquid chromatograph with precise amount, the chromatogram was recorded; An appropriate amount of cefotaxime reference substance was taken and determined by the same method. The content of C16H17N5O7S2 in the sample was calculated by peak area according to external standard method.
Last Update：2022-01-01 11:41:57
cefotaxim sodium salt - Category
Authoritative Data Verified Data
B-lactam antibiotics, cephalosporins
Last Update：2022-01-01 11:41:57
cefotaxim sodium salt - Storage
Authoritative Data Verified Data
sealed and stored in a cool, dark and dry place.
Last Update：2022-01-01 11:41:57
cefotaxim sodium salt - Cefotaxime sodium for injection
Authoritative Data Verified Data
This product is a sterile powder of cefotaxime sodium. The content of cefotaxime (C16H17N507S2) shall not be less than 90% calculated as anhydrous, and the content of cefotaxime (C16H17N507S2) shall be 93.0% to 107.0% of the label amount calculated as average loading.
trait
This product is white to yellowish crystal or powder.
identification
The same results were shown in the tests (1) and (3) for the identification of cefotaxime 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 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). Take 10ml of the above solution, add 1ml of glacial acetic acid, shake well, immediately check, the solution should be clear; If it is turbid, it should not be more concentrated compared with No. 1 turbidity standard solution (General rule 0902 method 1). In case of color development, it shall not be deeper in comparison with the yellow or yellow-green or orange-yellow Standard Colorimetric solution No. 7 (general rule 0901 method 1).
- the contents under the item of difference in loading amount of related substances were measured according to the method under the item of cefotaxime sodium. The single impurity peak area shall not be more than 3 times (3.0%) of the main peak area of the control solution, and the sum of the impurity peak areas shall not be more than 5 times (5.0%) of the main peak area of the control solution.
- the content of the cefotaxime polymer in terms of the difference in the take-up amount was measured according to the method of cefotaxime sodium. The amount of cefotaxime-containing polymer should not exceed 1.0% of the labeled amount.
- insoluble particles this product is taken, and the solution containing 50mg per 1 ml of water is prepared by adding particles according to the labeled amount and checking 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 lg of sample shall be converted to a label amount of less than 1.0g; the label amount is more than l.0g (including l.Og) no more than 6000 particles of l0um and 10um or more and no more than 600 particles of 25um25um or more in each sample container.
- acidity, moisture, bacterial endotoxin and sterility should be checked according to the method of cefotaxime sodium.
- 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 of cefotaxime sodium under the item.
category
Same as cefotaxime sodium.
specification
Based on C16H17N507S2 (1)0.5g (2) 1.0g(3) 2.0g
storage
sealed and stored in a cool, dark and dry place.
Last Update：2022-01-01 11:41:58
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View History
cefotaxim sodium salt
2-bromoacetyl chloride
MTHPA-EG
5-NITRO-2-CRESOL
N-Ethylimidazole
879-65-2
GTS-21 (DMXB-A)
2-bromoacetyl chloride
MTHPA-EG
5-NITRO-2-CRESOL
N-Ethylimidazole
879-65-2
GTS-21 (DMXB-A)
Raw Materials for cefotaxim sodium salt
N,N-Dimethylformamide
2-(2-Aminothiazole-4-yl)-2-methoxyiminoacetic acid
Acetone
Methyl alcohol
Ethyl Alcohol
2-(2-Aminothiazole-4-yl)-2-methoxyiminoacetic acid
Acetone
Methyl alcohol
Ethyl Alcohol