107648-80-6
Cefepime hydrochloride
CAS: 107648-80-6
Molecular Formula: C19H25ClN6O5S2
107648-80-6 - Names and Identifiers
107648-80-6 - Physico-chemical Properties
| Molecular Formula | C19H25ClN6O5S2 |
| Molar Mass | 553.49 |
| Melting Point | 230 °C (decomp) |
| Physical and Chemical Properties | Storage Conditions: Store at 0-5 ℃ |
107648-80-6 - Standard
Authoritative Data Verified Data
This product is chlorinated l-[ [(6R,7R)-7-[(2Z)-(2-aminothiazol-4-yl)]-2-(methoxyimino) acetamido]-2-carboxy-8-oxo-5-thia-1-azabicyclo [4. 2.0] oct-2-en-3-yl] methyl]-1-methylpyrrolidine monohydrochloride monohydrate. Cefepime (C19H24N605S2) should be present in the range of 82.5% to 91.1%, calculated as anhydrous.
Last Update：2024-01-02 23:10:35
107648-80-6 - Trait
Authoritative Data Verified Data
- This product is white to yellowish powder or crystalline powder; Slightly odorous, with hygroscopicity.
- This product is soluble in water or methanol, slightly soluble in ethanol, insoluble in ether.
specific rotation
take this product, precision weighing, adding water to dissolve and quantitatively dilute to make a solution containing about 10 mg per lml, and determine according to law (General rule 0621). The specific rotation is 39 ° to 47 °.
absorption coefficient
take this product, precision weighing, add water to dissolve and quantitatively dilute to make a solution containing about 15ug per lml, according to UV-visible spectrophotometry (General 0401), the absorbance was measured at a wavelength of 259nm, and the absorption coefficient was 310 to 340.
Last Update：2022-01-01 14:22:07
107648-80-6 - 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 1184).
- the aqueous solution of this product was chloride identification (1) of the reaction (General 0301).
Last Update：2022-01-01 14:22:08
107648-80-6 - Exam
Authoritative Data Verified Data
acidity
take this product, add water to make a solution containing lOmg per lml, and determine it according to law (General 0631). The pH value should be 1.6~2.1.
clarity and color of solution
take 5 parts of this product, each 1.2g, respectively, and add 10ml of water 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 or orange-yellow Standard Colorimetric solution No. 8 (General rule 0901 method 1).
Related substances
The solution should be freshly prepared or refrigerated at 4~8°C within 12 hours. Accurately weigh about 70mg of this product, put it in 50ml measuring flask, add mobile phase A to dissolve and dilute to the scale, shake, as A test solution; Take 1ml of precision measurement, put it in 100ml measuring flask, dilute to the scale with mobile phase A and shake well as A control solution. 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 (pH 5.0 )(take potassium dihydrogen phosphate 0.68g, add water to dissolve and dilute to 1000ml, with 0.5mol/L sodium hydroxide solution to adjust the pH value to 5.0)-acetonitrile (90:10) as mobile phase A, phosphate buffer (pH 5.0)-acetonitrile (50:50) mobile Phase B; Flow rate was 1.0ml per minute, linear gradient elution was carried out as follows; Detection wavelength was 254mn. The system applicable solution 10u1 under the content determination item is injected into the liquid chromatograph, and the chromatogram is recorded. The separation degree between the cefepime peak and the cefepime isomer peak shall meet the requirements. The sample solution and the control solution were respectively injected with human liquid chromatography, and the chromatograms were recorded. If there are impurity peaks in the chromatogram of the test solution, the peak area of cefepime isomer shall not be greater than 0.3 times (0.3%) of the main peak area of the control solution, other single impurity peak area shall not be greater than 0.2 times (0.2%) of the main peak area of the control solution, and the sum of each impurity peak area shall not be greater than the main peak area of the control solution (1.0%), 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.
N-methylpyrrolidine
- first method. Determination by capillary electrophoresis (General 0542).
- electrophoresis conditions and system applicability test an uncoated elastic quartz capillary with an inner diameter of 75um and an effective length of 56cm was used; Imidazole-acetic acid buffer solution with pH 4.7 (0.Olmol/L imidazole solution, using 1 mol/L acetic acid solution to adjust the pH value to 4.7) as the operation buffer; The column temperature was 25°C; The detection wavelength was 214nm (the indirect detection voltage was 30kV; the injection method was Pressure injection (50mbar,5 seconds). The new capillary should be sequentially washed with 1 mol/L sodium hydroxide solution, 1 mol/L hydrochloric acid solution, acetonitrile and water for 5 minutes. In the middle of the two injections, the capillary should be washed with 0.1 mol /L sodium hydroxide solution and the Operation Buffer solution for 3 minutes. Take N-methyl pyrrolidine reference solution sample, the migration order is: ethylamine and N-methyl pyrrolidine, N-methyl pyrrolidine peak and ethylamine peak separation degree should be greater than 2.0, the relative standard deviation of several injection results should not exceed 5.0%.
- A new assay was used. Accurately weigh about 200mg of this product, put it in a 10ml measuring flask, and add the internal standard solution (take an appropriate amount of ethylamine hydrochloride and dilute it with water to about O per lml. 1 mg of the solution) was dissolved and diluted to the scale, and then the sample was injected immediately and the electropherogram was recorded. Another 25mg of N-methylpyrrolidine reference substance was accurately weighed and placed in a 50ml measuring flask, dilute to the scale with internal standard solution, shake well, as a reference stock solution, take 10ml accurately, put it in a 50ml measuring flask, dilute to the scale with internal standard solution, shake well, as a control solution, the same method. The peak area shall be calculated according to the internal standard method and shall not exceed 0.3%.
methylpyrrolidine
- second method. Determined by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using carboxylic acid bonded silica gel as filler; 0.Olmol/L nitric acid solution-acetonitrile (99:1) as mobile phase; Flow rate was 0.8mL per minute; Column temperature was 35°C; Conductivity detection. Take an appropriate amount of this product and N-methylpyrrolidine, add O.Olmol/L nitric acid solution to dissolve and dilute to prepare a mixed solution containing cefepime 5mg and N-methylpyrrolidine 15 μl per 1 ml. 20ul of the mixed solution was injected into the human liquid chromatograph, and the chromatogram was recorded, which was used to locate the N-methylpyrrolidine peak in the sample solution. Precision take N-methyl pyrrolidine reference solution 20u1 injection liquid chromatograph, calculate the results of several injection, the relative standard deviation shall not exceed 5.0%.
- A new assay was used. Take this product about 125mg, precision weighing, 25ml flask, plus O.Olmol/L nitric acid solution is dissolved and diluted to the scale, and then it is used as a test solution. A 20ul injection liquid chromatograph is accurately measured and the chromatogram is recorded; in addition, an appropriate amount of N-methylpyrrolidine reference substance was accurately weighed, and O.Olmol/L nitric acid solution was quantitatively diluted to prepare a solution containing 15ug per 1 ml, which was used as a reference solution and was determined by the same method. The peak area shall be calculated according to the external standard method and shall not exceed 0.3%.
- residual solvent take about lg of this product, weigh it accurately, put it in a 10ml measuring flask, dilute it with water to the scale, shake it well, and use it as a stock solution for test; accurately measure lml into the top empty bottle, then accurately add lml of water, shake well, seal, and use as the test solution; Accurately weigh 0.15g of methanol and 0.25g of acetone, in a 50ml measuring flask, dilute to the scale with water, shake well, take 10ml precisely, in a 100ml measuring flask, dilute to the scale with water, shake well, and use as a reference stock solution; take the reference stock solution (lml) accurately and put it in the top-empty bottle, then add water (1ml) accurately, shake well and seal it as the system applicable solution; Take the reference stock solution (lml) precisely and put it in the top-empty bottle, then, 1ml of the stock solution of the test article was added precisely, shaken well, sealed, and used as a 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, and the column temperature is 40 ° C., which is maintained for 12 minutes; the inlet temperature is 200°C; The detector temperature is 250°C; The headspace bottle equilibrium temperature is 70°C, and the equilibrium time is 30 minutes; The system applicable solution is sampled by Headspace injection, the order of peak: methanol, acetone, methanol peak and acetone peak separation should meet the requirements. The test solution and the reference solution are injected in the headspace respectively, the chromatogram is recorded, and the peak area is calculated by the standard addition method. The residual amount of methanol and acetone shall be in accordance with the regulations.
moisture
take this product, according to the moisture determination method (General 0832 first method 1), the moisture content should be 3.0% ~ 4.5%.
ignition residue
take l.Og of this product and check it according to law (General rule 0841). The residue left shall not exceed 0.1%.
Heavy metals
The residue left under the item of burning residual sores shall be inspected according to law (General Principles 0821, second law) and shall not contain more than 20 parts per million of heavy metals.
visible foreign body
take 5 parts of this product, each part is the maximum specification of the preparation, and the particle inspection water is dissolved, and the inspection is carried out according to law (General rule 0904), and the requirements shall be met. (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 lOum or more, and no more than 600 particles containing 25um or more. (For aseptic dispensing)
bacterial endotoxin
take this product, add 2% endotoxin-free sodium carbonate solution appropriate amount, to dissolve, check according to law (General rule 1143), each 1 mg cefepime containing endotoxin amount should be less than 0.060EU. (For injection)
sterile
take this product, add 0.9% sterile sodium chloride solution to dissolve and dilute to make a solution containing 20mg per 1 ml, and treat it by membrane filtration, wash with 0.1% sterile peptone solution (not less than 400ml 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 14:22:10
107648-80-6 - 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; Phosphate buffer (pH 5.0 )(take potassium dihydrogen phosphate 0.68g, dissolve in water and dilute to 1000ml, the pH value was adjusted to 0.5 with 5.0 mol/L sodium hydroxide solution)-acetonitrile (90:10) as mobile phase; The detection wavelength was 254mn. Appropriate amounts of cefepime reference substance and cefepime isomer reference substance were dissolved and diluted with mobile phase to prepare solutions containing 1.2mg per 1 mL respectively as system applicable solutions. l0ul was injected into human liquid chromatograph, and the chromatogram was recorded, the resolution between cefepime peak and cefepime isomer peak should meet the requirements.
assay
take about 70mg of this product, weigh it accurately, put it in a 50ml measuring flask, add the mobile phase to dissolve and dilute to the scale, shake it well, and use it as a test solution, 10u1 was injected into the liquid chromatograph accurately, and the chromatogram was recorded. Cefepime was also measured by the same method. The content of C19H24N6O5S in the sample was calculated by the peak area according to the external standard method.
Last Update：2022-01-01 14:22:10
107648-80-6 - Category
Authoritative Data Verified Data
B-lactam antibiotics, cephalosporins.
Last Update：2022-01-01 14:22:10
107648-80-6 - Storage
Authoritative Data Verified Data
It was shielded from light, sealed, and stored in a cool-dark dry place.
Last Update：2022-01-01 14:22:10
107648-80-6 - Cefepime hydrochloride for injection
Authoritative Data Verified Data
This product is cefepime hydrochloride and appropriate amount of arginine made of sterile powder. The content of cefepime (C19H24N605S2) shall be 82.5% ~ 91.1% based on the calculation of anhydrous and arginine-free substances; The content of cefepime (C19H24N6O5S2) shall be 90.0% ~ 115.0% of the labeled amount based on the average loading.
trait
This product is white to yellowish powder.
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 control solution.
examination
- acidity: take this product, add water to make a solution containing 0.lg of cefepime per 1 ml, and determine it according to law (General rule 0631). The pH value should be 4.0~6.0.
- the clarity and color of the solution take 5 bottles of this product and add water to make each 1 ml containing cefepime 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 than the yellow or yellow-green or orange-yellow Standard Colorimetric solution No. 10 (Method 1 of general chapter 0901).
- the contents under the item of difference in loading amount of related substances shall be uniformly mixed, and an appropriate amount shall be accurately weighed, dissolved and diluted with mobile phase to prepare a solution containing 1.4mg of cefepime per 1 ml, as a test solution. According to the method under cefepime hydrochloride determination, cefepime; Isomer peak area shall not be greater than the control solution Main Peak area of 0.5 times (0.5% ) , other single impurity peak area shall not be greater than 0.5 times (0.5%) of the main peak area of the control solution, and the sum of each impurity peak area shall not be greater than 2.0 times (2.0%) of the main peak area of the control solution.
- N-methyl B: first method. New system was applied. Take 1 bottle of this product and add the internal standard solution to make a solution containing 20mg of cefepime in each lml as the test solution. According to the method of cefepime hydrochloride. Take 1 part of the test solution and 10 parts of the N-methylpyrrolidine reference solution, mix well, and immediately inject the sample, the order of migration is: ethylamine, N-methylpyrrolidine and arginine, the resolution between the N-methylpyrrolidine peak and the arginine peak should be greater than 2.0. The amount of N-methylpyrrolidine contained in the test solution shall not exceed 1.0% of the labeled amount.
- second method of N-methylpyrrolidine. New system was applied. Take the contents under the difference of loading, mix evenly, weigh an appropriate amount (about 125mg equivalent to cefepime) accurately, put it in a 25ml measuring flask, add 0. The 1 mol /L nitric acid solution was dissolved and diluted to the scale, and was shaken to obtain a test solution. The content of iV-methylpyrrolidine was determined according to the method described under cefepime hydrochloride to be 1.0% of the unlabelled amount.
- the moisture content of this product shall not exceed 0832 as determined by the method for determination of moisture (General rule 4.0%, first method 1).
- 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. No more than 6000 particles with lOum and more than 10um and no more than 600 particles with 25um and more than 25um in the Og sample; The labeled 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.
- bacterial endotoxin this product, according to the law inspection (General 1143), each 1 mg cefepime containing endotoxin amount should be less than 0.060EU.
- sterile take this product, according to the method of cefepime hydrochloride inspection, should comply with the provisions.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; With 0.015mol/L sodium octane sulfonate 0.1 mol/L sodium dihydrogen phosphate solution (pH value was adjusted to 5.0 with sodium hydroxide solution)-methanol (92:8) as mobile phase; Flow rate was 1.5ml per minute; Detection wavelength was 206nm. The reference solution lOul was injected into the liquid chromatograph, and the chromatogram was recorded. The resolution between cefepime peak and arginine peak should meet the requirements.
- determine the contents under the item of loading difference, mix evenly, weigh an appropriate amount (about 60mg equivalent to cefepime) accurately, put it in a 200ml measuring flask, add water to dissolve and dilute to the scale, shake, as a test solution, take 10u1 injection of human liquid chromatography with precision, record chromatogram; Take cefepime reference about 30mg and arginine reference about 20mg, in a 100ml measuring flask, add water to dissolve and dilute to the scale, shake well, and measure with the same method. The content of C19H24N605S2 and C6H14N402 in the sample was calculated by the peak area according to the external standard method.
category
with cefepime hydrochloride.
specification
Based on C19H24N605S2 (1)0.5g (2) 1.og
storage
It was sealed and kept in a cool and dark place.
Last Update：2022-01-01 14:22:11
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Spot supply
Product Name: Cefepime hydrochloride Request for quotationCAS: 107648-80-6
Tel: +86-17551318830
Email: r@reformchem.com
Mobile: +86-17551318830
QQ: 3785839865
Product Name: Cefepime hydrochloride Request for quotation
CAS: 107648-80-6
Tel: 17505222756
Email: pules.cn@gmail.com
Mobile: +86-17551318830
Wechat: 17505222756
CAS: 107648-80-6
Tel: 17505222756
Email: pules.cn@gmail.com
Mobile: +86-17551318830
Wechat: 17505222756
Product Name: Cefeprime dihydrochloride Visit Supplier Webpage Request for quotation
CAS: 107648-80-6
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409
Wechat: 18301782025
CAS: 107648-80-6
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409
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