Cephalothin sodium
cephalotin sodium salt
CAS: 58-71-9
Molecular Formula: C16H16N2O6S2.Na
Cephalothin sodium - Names and Identifiers
| Name | cephalotin sodium salt |
| Synonyms | synclotin cefalotinasodica cefalotin sodium Cefalothin Sodium cefalothinesodium cephalotin sodium sodium cephalothin Sodium cephalothin Cephalothin Sodium cephalotin sodium salt Cephalothin sodium salt cephalothin sodium crystalline cephalothin sodium cell culture tested 7-(2-(2-thienyl)acetamido)-,acetate,monosodiumsalt Cephalotin sodium salt, Antibiotic for Culture Media Use Only SodiuM (6R,7R)-3-(acetoxyMethyl)-8-oxo-7-(2-(thiophen-2-yl)acetaMido)-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate monosodium (6r,7r)-3-acetoxymethyl-8-oxo-7-[2-(thiophen-2-yl)acetylamido]-5-thia-1-azabicyclo[4.2.0.]oct-2-ene-2-carboxylate |
| CAS | 58-71-9 |
| EINECS | 200-394-6 |
| InChI | InChI=1/C16H16N2O6S2.Na/c1-8(19)24-6-9-7-26-15-12(14(21)18(15)13(9)16(22)23)17-11(20)5-10-3-2-4-25-10;/h2-4,12,15H,5-7H2,1H3,(H,17,20)(H,22,23);/q;+1/t12-,15-;/m1./s1 |
Cephalothin sodium - Physico-chemical Properties
| Molecular Formula | C16H16N2O6S2.Na |
| Molar Mass | 418.42 |
| Melting Point | 240°C |
| Boling Point | 757.2°C at 760 mmHg |
| Specific Rotation(α) | D +135° (c = 1.0 in water) |
| Water Solubility | 158 mg/L |
| Solubility | Easily soluble in water, slightly soluble in ethanol, insoluble in chloroform or ether |
| Appearance | White crystalline powder |
| Color | White to Off-White |
| Merck | 13,1994 |
| BRN | 4120706 |
| Storage Condition | Inert atmosphere,2-8°C |
| Stability | Hygroscopic |
| MDL | MFCD00072025 |
| Physical and Chemical Properties | Cefalotin (alkali) melting point 160-160.5 ° C., sodium salt ([58-71-9]) is a white crystalline powder. Soluble in water, ethanol-soluble, insoluble in chloroform or ether, aqueous solution at low temperature is relatively stable. Almost odorless. |
| Use | Broad-spectrum breeding period of bactericidal antibiotics, penicillin enzyme stability, strong anti-gram-positive bacteria |
Cephalothin sodium - 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. |
| WGK Germany | 2 |
| RTECS | XI0388300 |
| HS Code | 29419000 |
| Toxicity | LD50 in mice, rats (mg/kg): >20000, >10000 orally; 5670, 7716 i.p. (Kuramoto) |
Cephalothin sodium - Standard
Authoritative Data Verified Data
This product is (6R,7R)-3-[(Acetoxy) methyl]-7-[2-(2-thienyl) acetamido]-8-oxo-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylic acid sodium salt. The content of cefalotin (C16H16N2O6S2) shall not be less than 90.0% calculated as anhydrous.
Last Update：2024-01-02 23:10:35
Cephalothin sodium - Trait
Authoritative Data Verified Data
- This product is white or off-white crystalline powder; Almost odorless.
- This product is soluble in water, slightly soluble in ethanol, insoluble in ether.
specific rotation
take this product, precision weighing, adding water to dissolve and quantitatively dilute the solution containing about 30mg per lml, according to the law (General 0621), the specific rotation is 124 ° to 134 °.
Last Update：2022-01-01 11:41:49
Cephalothin sodium - 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 129).
- This product shows the reaction of sodium salt identification (1) (General rule 0301).
Last Update：2022-01-01 11:41:50
Cephalothin sodium - Exam
Authoritative Data Verified Data
acidity
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 4.5~7.0.
clarity and color of solution
take 5 parts of this product, each 0.6g, respectively, after adding water 5ml to dissolve, the solution should be clear and colorless; If it is turbid, compare 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 or yellow-green standard colorimetric solution No. 5 (general principles 0901 first method).
absorbance
take this product, add water to dissolve and quantitatively dilute the solution containing 20ug per lml, according to UV-visible spectrophotometry (General 0401), at the wavelength of 237nm, the absorbance was 0.65 to 0.72.
Related substances
take about 75mg of this product, put it in a 25ml measuring flask, add water to dissolve and dilute to the scale, shake well, and use it as a test solution; Take 1 ml for precision measurement, put it in a 100ml measuring flask, as a control solution, it was diluted to the scale with water and shaken. According to the determination by high performance liquid chromatography (General rule 0512), silica gel bonded with eighteen alkyl silane is used as the filler; Phosphate buffer (pH2.3) (take dipotassium hydrogen phosphate 1.742g, add water to dissolve and dilute to 1000ml, adjust pH to 2.3 with phosphoric acid)-acetonitrile (970:30) as mobile phase A, phosphate buffer (pH 2.3)-acetonitrile (600:400) as mobile phase flow rate of 1.0ml per minute; the linear gradient elution was carried out as follows; The column temperature was 40°C; And the detection wavelength was 220mn. Take 1 ml of test solution, add 1 ml of hydrochloric acid solution (l-4) and 8ml of water, shake well, heat in a water bath at 60°C for about 12 minutes, and immediately cool in an ice bath, immediately take 20u1 injection human liquid chromatograph, record chromatogram, the retention time of cefalotin peak is about 26 minutes, the relative retention time of impurity C, impurity B, impurity D and impurity A are about 0.2, 0.7, 0.9 and 0.96, the separation degree between the impurity D peak and the peak of the peak should be greater than 7.0. 2 u1 of the test solution and the control solution were accurately measured, and the human liquid chromatograph was injected respectively, and the chromatogram was recorded. If there are impurity peaks in the chromatogram of the test solution, the peak area of impurity B shall not be greater than the main peak area of the control solution (1.0% ) , and the peak area of impurity D shall not be greater than 0.5 times (0.5%) of the main peak area of the control solution, other single impurity peak area shall not be greater than 0.25 times (0.25%) of the main peak area of the control solution, 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.
cefalotin polymer
measured by size exclusion chromatography (General 0514).
chromatographic conditions and system suitability test
with dextran gel G -10(40 ~ 120um) as the filler, the inner diameter of the glass column is 1.0~1.4, the length of the column is 30 ~ 40cm, using 7.0 mol/L phosphate buffer (pH 0.02) [0.02moI/L disodium hydrogen phosphate solution -0.02mol/L sodium dihydrogen phosphate solution (61:39)] as mobile phase A and water as mobile Phase B, the flow rate is about 1.0ml per minute, the detection wavelength is 254mn, take 0. LMG/ml Blue dextran 2000 solution 100~200 u1, inject human liquid chromatograph, respectively with mobile phase A, B as mobile phase, the chromatogram was recorded, and the number of theoretical plates was calculated according to the Blue dextran 2000 peak, which was not less than 400, and the tailing factor should be less than 2.0. In both mobile phase systems, the ratio of the retention times of the Blue dextran 2000 peak 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. In addition, the mobile phase B is used as the mobile phase, and the control solution 100~200u1 is continuously injected for 5 times, and the relative standard deviation of the peak area should not be more than 5.0%.
preparation of control solution
About 25mg cefalotin reference, precision weighing, dissolved in water and quantitative dilution to make a solution containing about 25ug 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 it to the scale, shake it well, immediately inject 100-200ul into human liquid chromatograph, use mobile phase A as mobile phase for measurement, and record chromatogram. Another precision amount of 100 ~ 200ul of the control solution is injected into the liquid chromatograph, and the mobile phase B is used as the mobile phase, and the same method is used for determination. According to the external standard method, the amount of cefalotin-containing polymer should not exceed 0.10%.
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. As a stock solution for the test, take a precise amount of lml into the top empty bottle, then add 1ml of water precisely, shake, seal, and use as a test solution; in addition, weigh ethanol and acetone about 0.25g each accurately, put them in a 50ml measuring flask, dilute them to the scale with water, shake them well, take 10ml accurately, put them in a 100ml measuring flask, dilute them to the scale with water, shake well, as a reference stock solution; Take 1ml of the reference stock solution precisely, place it in the top empty bottle, add 1ml of water precisely, shake well, seal, as a system applicable solution; the stock solution of the reference substance (1ml) was accurately weighed and placed in the top empty bottle. The sample stock solution (1ml) was accurately added and shaken, sealed and used as the reference solution. According to the determination method of residual solvent (General Principle 0861 first method), the capillary column with 100% dimethylpolysiloxane (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 was 200°C; The equilibrium temperature of the headspace bottle was 70°C, and the equilibrium time was 30 minutes; The system applicable solution was sampled by Headspace injection, and the chromatogram was recorded. The order of peak: ethanol, acetone, the separation between the two peaks should meet the requirements. The relative standard deviation shall not exceed 5.0% by taking the headspace injection of the reference solution and calculating the injection results for several times. The test solution and the reference solution are injected in the headspace respectively, and the chromatogram is recorded. The peak area is calculated according to the standard addition method, and the residual amount of ethanol and acetone shall be in accordance with the regulations.
2-ethylhexanoic acid
take the right amount of this product, according to the law (General 0873), not over 0.5%.
moisture
take this product, according to the determination of moisture (General 0832 first method 1), the water content shall not exceed 1.2%.
visible foreign body
take 5 parts of this product, each l.O g, plus particle inspection water dissolution, inspection according to law (General rule 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), 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 1143), each 1 mg of cefalotin containing endotoxin amount 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 11:41:51
Cephalothin 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 eighteen alkyl silane as filler; With acetate buffer (sodium acetate 21.5g, dissolved in water and diluted to 1000ml, and adjust the pH value to 5.9±0.1 with glacial acetic acid)-Acetonitrile-ethanol (790:150:70) as mobile phase; Column temperature was 40°C; Detection wavelength was 254nm. Take 5ml of the reference solution, place it in a water bath at 90°C for 10 minutes to generate deacetylcefalotin, let it cool, and immediately inject 10u1 into the liquid chromatograph, the separation degree between cefalotin peak and deacetylcefalotin peak should be greater than 9.0, and the tailing factor of cefalotin peak should not be greater than 1.8.
assay
take an appropriate amount of this product, accurately weigh it, add the mobile phase to dissolve and quantitatively dilute to prepare a solution containing about 1 mg per 1 ml as the test solution, take 1ou1 injection liquid chromatograph accurately, record chromatogram; Take appropriate amount of cefalotin reference substance, and calculate the content of C16H16N2O6S2 in the test sample by peak area according to external standard method.
Last Update：2022-01-01 11:41:52
Cephalothin sodium - Category
Authoritative Data Verified Data
B-lactam antibiotics, cephalosporins.
Last Update：2022-01-01 11:41:52
Cephalothin sodium - Storage
Authoritative Data Verified Data
sealed and stored in a cool, dark and dry place.
Last Update：2022-01-01 11:41:53
Cephalothin sodium - Cefalotin Sodium for Injection
Authoritative Data Verified Data
This product is a sterile powder of cefalotin sodium. Calculated as anhydrous, containing cefalotin (C16H16N206S2) shall not be less than 90.0%; Calculated as the average loading, containing cefalotin (C16H16N2O6S2) shall be 95.0% ~ 105.0% of the label amount.
trait
This product is white or off-white crystalline powder.
identification
take this product, according to cefalotin sodium under the identification test, showed the same results.
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, 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. 8 (General rule 0901 method 1).
- the moisture content of this product shall not exceed 0832 as determined by the method for determination of moisture (General rule 1.5%, first method 1).
- 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), the labeled amount of less than 1.0g is converted to the sample containing 10um and more than 6000 particles per lg, containing 25um and more than 25um particles shall not exceed 600. No more than 6000 particles of 10um and lOum or more and no more than 600 particles of 25um and 25um or more are contained in each container of the test article with the labeled amount of 1.0g.
- the acidity, related substances, ceforonin polymer, bacterial endotoxin and sterility should be checked according to the method of cefalotin sodium.
- except that the difference in loading amount shall not exceed ± 7.0%, the relevant provisions under injection (General rule 0102) shall be met.
Content determination
The content under the item of loading amount difference was accurately weighed and an appropriate amount was measured according to the method of cefalotin sodium.
category
Same as cefalotin sodium.
specification
Based on C16H16N2O6S2 (1)0.5g (2) 1.og
storage
sealed and stored in a cool, dark and dry place.
Last Update：2022-01-01 11:41:53
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View History
Cephalothin sodium
2-氟-4-甲氧基甲酰苯硼酸
CIS-2-(TERT-BUTOXYCARBONYLAMINO)-1-CYCLOPENTANECARBOXYLIC ACID
ISOCYANIC ACID 2-CHLOROETHYL ESTER
4-亚硝基-3-羟基-2,7-萘二磺酸 二钠盐
2-氟-4-甲氧基甲酰苯硼酸
CIS-2-(TERT-BUTOXYCARBONYLAMINO)-1-CYCLOPENTANECARBOXYLIC ACID
ISOCYANIC ACID 2-CHLOROETHYL ESTER
4-亚硝基-3-羟基-2,7-萘二磺酸 二钠盐