sq11436
Cefradine
CAS: 38821-53-3
Molecular Formula: C16H19N3O4S
sq11436 - Names and Identifiers
sq11436 - Physico-chemical Properties
| Molecular Formula | C16H19N3O4S |
| Molar Mass | 349.4 |
| Density | 1.2794 (rough estimate) |
| Melting Point | 140-142 C |
| Boling Point | 898℃ |
| Flash Point | >110°(230°F) |
| Water Solubility | Soluble in water |
| Solubility | Soluble in water |
| Appearance | White crystalline powder |
| Color | White |
| pKa | 2.63, 7.27(at 25℃) |
| Storage Condition | Keep in dark place,Inert atmosphere,2-8°C |
| Stability | Light Sensitive |
| Refractive Index | 1.6320 (estimate) |
| MDL | MFCD00865048 |
| Use | It is a semi-synthetic broad-spectrum cephalosporin, and its antibacterial spectrum and use are similar to those of cephalexin |
sq11436 - Risk and Safety
| Risk Codes | R36/37/38 - Irritating to eyes, respiratory system and skin. R42/43 - May cause sensitization by inhalation and skin contact. R20/21/22 - Harmful by inhalation, in contact with skin and if swallowed. |
| Safety Description | S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S36 - Wear suitable protective clothing. S45 - In case of accident or if you feel unwell, seek medical advice immediately (show the label whenever possible.) S36/37 - Wear suitable protective clothing and gloves. S22 - Do not breathe dust. |
| WGK Germany | 1 |
| RTECS | XI0336000 |
| HS Code | 29419054 |
sq11436 - Upstream Downstream Industry
| Raw Materials | Dichloromethane |
sq11436 - Reference
| Reference Show more | 1. Liu Min-Xuan, Zhao Xing-ran, Yu Lu, Lu Hao-Zhi, Wang Xiang-hong. Rapid detection of cefalexin residues in animal derived food by colloidal gold strip [J]. Food Research and Development, 2020,41(15):150-155. 2. Zhou, Yitian, et al. "Effective capture of cefradines in water with a high stable Zr (IV)-based bimetal-organic Framework." Industrial & Engineering Chemistry Research 58.41 (2019): 19202-19210. 3. [IF = 4.759] Shujuan Chen et al."Preparation and application of magnetic molecular imprinted polymers for extraction of cephalexin from pork and milk samples."J Chromatogr A. 2019 Sep;1602:124 4. [IF=3.72] Yitian Zhou et al."Effective Capture of Cefradines in Water with a Highly Stable Zr(IV)-Based Bimetal-Organic Framework."Ind Eng Chem Res. 2019;58(41):19202-19210 |
sq11436 - Standard
Authoritative Data Verified Data
This product is (6R,7R)-7-[(R)-2-amino -2-(l, 4-cyclohexadien-1-yl) acetamido]-3-methyl-8-oxo-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylic acid. The content of cephradine (C16H19N304S) shall not be less than 90.0% calculated as anhydrous.
Last Update：2024-01-02 23:10:35
sq11436 - Trait
Authoritative Data Verified Data
- This product is white or off-white crystalline powder; Slightly odorous.
- This product is slightly soluble in water, and almost insoluble in ethanol or ether.
specific rotation
take this product, precision weighing, add acetate buffer (take sodium acetate 1.36g, add water about 50ml to dissolve, adjust pH to 4.6 with glacial acetic acid, dilute to 100ml with water) dissolve and quantitatively dilute to make a solution containing about 10 mg per 1 ml. Measured according to law (General rule 0621), the specific rotation is 80 ° to 90 °.
Last Update：2022-01-01 11:40:33
sq11436 - Introduction
White crystalline powder, slightly smelly.
Last Update：2022-10-16 17:25:02
sq11436 - Differential diagnosis
Authoritative Data Verified Data
- the appropriate amount of this product and the cefradine reference substance were dissolved and diluted with water to prepare a solution containing about 6mg per 1 ml as the test solution and the reference solution. According to the thin layer chromatography (General 0502) test, absorb 5 u1 of each of the above two solutions, respectively point on the same silica gel G thin layer plate [after activation at 105°C, 5%(ml/ml) n-hexane solution of N-decane, spread to the top of the thin layer plate, dry on], 0.1 mol/L phosphoric acid solution -0.2mol/L disodium hydrogen phosphate solution-acetone (60:40:1.5) as the developer, expand, take out, heat at 105°C for 5 minutes, immediately sprayed with a 0.1% ninhydrin solution made with the developing solvent, and after heating at 105°C for 15 minutes, examined. The position and color of the main spot displayed by the test solution should be the same as the position and color of the main spot displayed by the reference solution.
- 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 this product, add an appropriate amount of methanol to dissolve, volatilize to dryness at room temperature, take the residue as measured by infrared spectrophotometry (General rule 0402), the infrared absorption spectrum of this product should be consistent with the spectrum of the control (Spectrum set 722 figure).
- two items (1) and (2) above can be selected as one item.
Last Update：2022-01-01 11:40:34
sq11436 - Exam
Authoritative Data Verified Data
crystallinity
take a small amount of this product, according to the law inspection (General 0981), should comply with the provisions.
acidity
take this product, add water to make a solution containing 10 mg per lml, according to the law (General 0631), the pH value should be 3.5~6.0.
clarity and color of solution
take 5 parts of this product, each 0.55g, respectively, add sodium carbonate g and water 5ml after dissolution, the solution should be clear and colorless; If it is turbid, and 1 turbidity standard solution (General rule 0902 first method) comparison, shall not be more concentrated; If color, with yellow or yellow-green No. 5 standard colorimetric liquid (General Principles 0901 first method), shall not be deeper. (For injection)
cephalexin
The Test Solution was prepared according to the method under the content determination item; Another Cefalexin reference product about 20mg, precision weighing, placed in a 50ml measuring flask, plus about 30ml of flowing phase ultrasonic to dissolve, then dilute the mobile phase to the scale, shake well, take 5ml accurately, put it in a 50ml measuring flask, dilute the mobile phase to the scale, shake well, and use it as a reference solution. According to the chromatographic conditions under the content determination item, each lol of the test solution and the reference solution is accurately measured and injected into the human liquid chromatograph respectively. The chromatogram is recorded and the peak area is calculated according to the external standard method. The content of cefalexin should not exceed 5.0% based on anhydrous.
Related substances
precision weigh appropriate amount of this product, add mobile phase to dissolve and quantitatively dilute to prepare a solution containing lmg per lml as a test solution, A solution containing 5ug per lml was prepared by quantitative dilution with mobile phase and used as a control solution. The appropriate amounts of cefalexin, dihydrophenylglycine and 7-aminodeacetoxycephalosporin were accurately weighed, in the same measuring flask, add 4ml of 7.3% hydrochloric acid solution first, dissolve by ultrasound, and then quantitatively dilute with the control solution to make a mixed solution containing each lOug of the above three impurity reference substances in each lml, as an impurity control solution. According to the chromatographic conditions under the content determination item, the impurity reference solution 20 u1 is injected into the human liquid chromatograph, with the detection wavelength of 220nm, and the elution order is: 7-amino deacetoxy cephalosporin acid, dihydrophenylalanine, cephalexin and cephradine, the degree of separation between peaks should meet the requirements. The detection wavelength is 220mn and 254mn, and the sample solution, the impurity reference solution and the control solution are 20ul respectively, and the human liquid chromatograph is injected respectively, record the chromatogram to 2.5 times the retention time of the main component peak. If there are impurity peaks in the chromatogram of the test solution, except Cefalexin, dihydrophenylglycine (220nm detection) and 7-aminodeacetoxycephalosporanic acid (254mn detection), calculated by peak area according to external standard method, shall not exceed 1.0%; Other single impurities (254nm detection) the peak area shall not be greater than 4 times (2.0%) of the main peak area of the control solution, and the sum of the peak areas of other impurities (detected at 254nm) shall not be greater than 5 times (2.5%) of the main peak area of the control solution.
cephradine
polymers were determined by size exclusion chromatography (General 0514).
chromatographic conditions and system suitability test
A silica gel G -10 ( 40 to 1.0 um) was used as a filler, and the inner diameter of the glass column was 1.4cm to, and the length of the column was 30. 0.2mol/L phosphate buffer solution [0.2mol/L disodium hydrogen phosphate solution-0.2mol/L sodium dihydrogen phosphate solution (95:5 )] as mobile phase A, water was used as mobile Phase B, the flow rate was 1.0-1.5ml per minute, and the detection wavelength was 254mn. 0.2-200ul of 2000 mg/ml Blue dextran 100 solution was injected into the liquid chromatograph, and the measurement was carried out with the mobile phases A and B, respectively, and the chromatogram was recorded. According to the Blue dextran 2000 peak, the number of theoretical plates is not less than 400, and the tailing factor should be less than 2.0. The retention time ratio 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 to the polymer peak in the test solution and the Blue dextran 2000 peak in the corresponding chromatography system should be between 0.93 and 1.07. Weigh about 0.2g of cefradine, put it in a 10ml measuring flask, add 4ml of 2% anhydrous sodium carbonate solution to dissolve it, add 5ml of 0.6mg/ml Blue dextran 2000 solution, dilute it to the mark with water, shake well. Take 100~200u1 and inject it into human liquid chromatograph, measure with mobile phase A, and record chromatogram. 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 100-200ul of the control solution is accurately measured, and the sample is continuously injected for 5 times. The relative standard deviation of the peak area should not be more than 5.0%. (Before the measurement of the control solution, the gel column is rinsed with 0.2-0.5 ml of a mixed solution containing 200 mol/L sodium hydroxide and mol/L sodium chloride, and then rinsed with water until neutral.) Preparation of control solution an appropriate amount of cefradine control was taken, precisely weighed, dissolved with water and quantitatively diluted to make a solution containing about 10ug per 1 ml.
assay
take about 0.2g of this product, accurately weigh it, put it in a 10ml measuring flask, add 4ml of 2% anhydrous sodium carbonate solution, dissolve it, dilute it with water to the scale, and shake it well. Immediately inject 100~200u1 into human liquid chromatograph, use mobile phase A as mobile phase for measurement, and record chromatogram. 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 for measurement, and the chromatogram was recorded. According to the external standard method to calculate the peak area of cefradine, the amount of cefradine polymer should not exceed 0.05%.
2-naphthol
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
silica gel bonded with eighteen alkyl silane was used as a filler; Methanol-water (55:45) was used as a mobile phase at a flow rate of 1ml per minute and a detection wavelength of 225Nm. The reference solution 20u1 is injected into the liquid chromatograph, and the ratio of methanol in the mobile phase is adjusted so that the retention time of the 2-naphthol peak is about 1 minute, and the separation degree between the 2-naphthol peak and the adjacent peak should be not less than 1.5.
assay
take an appropriate amount of this product, accurately weigh, add mobile phase to dissolve and quantitatively dilute to make a solution containing about 10 mg per lml, fully shake and filter, take the continued filtrate as the test solution; Take an appropriate amount of 2-naphthol reference substance, precisely weigh, add mobile phase to dissolve and quantitatively dilute to make a solution containing about 0.5ug per lml, as the reference solution, accurately measure 20 u1 of each of the above two solutions, respectively inject into the liquid chromatograph, and record the chromatogram. According to the external standard method based on peak area, the amount of 2-naphthol shall not exceed 0.05% (for oral preparations) or 0.0025%. (For injection)
moisture
take this product, according to the moisture determination method (General 0832 first method 1), the water content shall not exceed 6.0%.
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%.
precious metals
The residue left under the item of burning residues shall not contain more than 20 parts per million of heavy metals after examination by law (General rule 0821, Law II).
visible foreign body
take 5 parts of this product, each of which is 2.og, add 3.0% arginine solution (filtered by 0.45um filter) to dissolve, check according to law (General rule 0904), should comply with the provisions. (For aseptic dispensing)
insoluble particles
Take 3 parts of this product, 2.0g each, add 3.0% arginine solution (filtered through 0.45um filter) to make a solution containing 50mg per 1 ml, and check according to law (General rule 0903), no more than 6000 particles with lOum or more and no more than 600 particles with 25um and 25um in each lg sample. (For aseptic dispensing)
bacterial endotoxin
take this product, add 2.6% endotoxin-free sodium carbonate solution to dissolve, check according to law (General 1143), the amount of endotoxin in each 1 mg cefradine should be less than 0.20El. (For injection)
sterile
take this product, with 2.6% sterile sodium carbonate solution dissolved and diluted, the membrane filtration method, inspection according to law (General Principles 1101), should comply with the provisions. (For aseptic dispensing)
Last Update：2022-01-01 11:40:35
sq11436 - 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 was used as filler, and water-methanol-3.86% sodium acetate solution -4% acetic acid solution (1564:400:30:6) was used as mobile phase; the flow rate was 0.7-0.9 per minute; The detection wavelength was 254mn. 10 parts of cefradine reference solution and 1 part of cefalexin reference solution (0.4 mg /ml) were mixed well, 10u1 was injected into the liquid chromatograph, and the chromatogram was recorded, the resolution between cephradine peak and cephalexin peak should meet the requirements.
assay
take about 70mg of this product, accurately weigh it, put it in a 100ml measuring flask, add about 70ml of mobile phase to dissolve by ultrasound, dilute it to the scale with the mobile phase, shake it well, and use it as a test solution, take 10u1 injection liquid chromatograph, record chromatogram; Another cefradine reference solution, the same method for determination. According to the external standard method to calculate the peak area, that is.
Last Update：2022-01-01 11:40:36
sq11436 - Category
Authoritative Data Verified Data
B-lactam antibiotics, cephalosporins.
Last Update：2022-01-01 11:40:36
sq11436 - Storage
Authoritative Data Verified Data
light shielding, nitrogen filling, sealing, and storage at less than 10°C.
Last Update：2022-01-01 11:40:36
sq11436 - Cefradine for Suspension
Authoritative Data Verified Data
This product contains cephradine (C16H19N304S) should be 90.0% to 120.0% of the label.
trait
This product is a flavor powder; Gas fragrance.
identification
take an appropriate amount of this product, add water to dissolve and dilute to prepare a solution containing about 6mg of cefradine per 1 ml, filter, and take the continued filtrate as the test solution, the same results were shown for the identification tests (1) or (2) under cefradine.
examination
- acidity: take this product, add water to make a suspension containing about 25mg of cefradine per 1 ml, and determine it according to law (General rule 0631). The pH value should be 3.5~6.0.
- sedimentation volume ratio of this product, according to the proportion when taking, add water with force shaking for 1 minutes, static for 45 minutes, should comply with the provisions (General 0123). (For multiple doses)
- taking cephalexin, preparing the test solution according to the method under the content determination item, and checking according to the method under the cefradine item, the content of cephalexin shall not exceed 6.0% of the total amount of cephradine and cephalexin.
- 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).
- dissolution the right amount of this product (about 0.25g equivalent to cefradine) shall be taken by precise weighing (multiple doses) according to the dissolution and release determination method (General rule 0931 method 2), 0.lmol/L hydrochloric acid solution 900ml as the dissolution medium, the rotation speed is 50 revolutions per minute, according to the operation, 30 minutes, take the appropriate amount of solution, filtration, precision take the appropriate amount of filtrate, with 0.1 mol/L hydrochloric acid solution is quantitatively diluted to prepare a solution containing about 28ug of cefradine per 1 ml as a test solution. 1 mol/L hydrochloric acid solution was dissolved and quantitatively diluted to prepare a solution containing about 28ug per 1 ml as a reference solution. The dissolution amount of each sample was calculated by peak area according to the method under the content determination of cefradine. The limit is 80% of the labeled amount and shall be in accordance with the provisions.
- others should comply with the relevant provisions under oral suspension (General rule 0123).
Content determination
take the contents under the difference of loading amount, mix evenly, weigh an appropriate amount (about equivalent to cefradine 70mg) accurately, put it in a 100ml measuring flask, and add about 70ml of mobile phase, cefradine was dissolved by ultrasound, then diluted to the scale with mobile phase, shaken well, filtered, and the filtrate was taken as the test solution, which was obtained according to the method of cefradine.
category
Same as cephradine.
specification
(1)0.125g (2)0.25g (3)1.5g (4)3.Og
storage
sealed, stored in the cool dark.
Last Update：2022-01-01 11:40:37
sq11436 - Cefradine tablets
Authoritative Data Verified Data
This product contains cephradine (C16H19N304S) should be 90.0% to 110.0% of the label.
trait
This product is a film-coated tablet, white or yellowish after removing the coating.
identification
take an appropriate amount of fine powder of this product, add water to dissolve and dilute to prepare a solution containing about 6mg of cefradine per 1 ml, filter, and take the continued filtrate as the test solution, the same results were shown for the identification tests (1) or (2) under cefradine.
examination
- Cefalexin precision weighing the appropriate amount of fine powder of this product, preparing the test solution according to the method under the content determination item, and measuring according to the method under the cefradine item, containing cephalexin should not exceed 6.0% of the total amount of cephradine and cephalexin.
- Related substances 10 tablets of this product, precision weighing, fine, precision weighing to take appropriate amount, plus mobile phase dissolution and quantitative dilution to make a solution containing about 1 mg of cefradine per 1 ml, filtering, the continued filtrate was taken as the test solution. According to the method under cefradine, the detection wavelength was 254nm. If there are impurity peaks in the chromatogram of the test solution, the 7-amino deacetoxycephalosporin acid shall be calculated by the external standard method based on the peak area except Cefalexin, and shall not exceed 1.0% of the labeled amount; other single impurity peak area shall not be more than 5 times (2.5%) of the main peak area of the control solution,
- the sum of the peak areas of other impurities shall not be greater than 6 times (3.0%) of the main peak area of the control solution.
- water content: take an appropriate amount of the fine powder of this product and determine the moisture content according to the moisture determination method (General rule 0832, first method 1). The moisture content shall not exceed 6.0%.
- dissolution: according to the dissolution and release determination method (General rule 0931 second method), 0.12mol/L hydrochloric acid solution was used as the dissolution medium, and the rotation speed was 75 rpm, operate in accordance with the law, 60 minutes, take the appropriate amount of solution, filtration, precision take the appropriate amount of filtrate, quantitative dilution with dissolution medium to make a solution containing about 25ug of cefradine per 1 ml, measure absorbance at the wavelength of 255mn by UV-Vis spectrophotometry (General rule 0401), the solution containing cefradine 25ug per 1 ml was prepared by dissolving and quantitatively diluting according to the labeled amount and dissolution medium. The solution was filtered, and the filtrate was taken. The limit is 85% 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, precision weighing appropriate amount (about equivalent to cefradine 70mg ), put in a 100ml measuring flask, add mobile phase 70ml, ultrasonic dissolution of cefradine, dilute with mobile phase to the scale, shake, filter, take the filtrate as a test solution, according to the method under the cefradine, that is obtained.
category
Same as cephradine.
specification
(1)0.25g (2)0.5g
storage
sealed, stored in the cool dark.
Last Update：2022-01-01 11:40:38
sq11436 - Cefradine Capsules
Authoritative Data Verified Data
This product contains cephradine (C14H19N304S) should be 90.0% to 110.0% of the label.
trait
The content of this product is white to light yellow powder or granules.
identification
take an appropriate amount of the contents of this product, add water to dissolve and dilute to prepare a solution containing about 6mg of cefradine per 1 ml, filter, and take the continued filtrate as the test solution, the same results were shown for the identification tests (1) or (2) under cefradine.
examination
- Cefalexin precision weigh the appropriate amount of the content of this product, prepare the test solution according to the method under the content determination item, and determine it according to the method under the cefradine item, containing cephalexin should not exceed 6.0% of the total amount of cephradine and cephalexin.
- 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 quantitatively diluted with mobile phase to prepare a solution containing about 1 mg of cefradine per 1 ml, and filtered, the continued filtrate was taken as the test solution. The detection wavelength was 254mn as determined by the method under cefradine. If there are impurity peaks in the chromatogram of the test solution, the 7-amino deacetoxycephalosporin acid shall be calculated by the external standard method based on the peak area except Cefalexin, and shall not exceed 1.0% of the labeled amount; the Peak area of other individual impurities shall not be more than 5 times (2.5%) of the main peak area of the control solution, and the sum of the peak areas of other impurities shall not be more than 6 times (3.0%) of the main peak area of the control solution.
- water content of this product is appropriate, according to the moisture determination method (General 0832 first method 1), the water content shall not exceed 7.0%.
- dissolution of this product, according to the dissolution and release determination method (General 0901 first method), with 0.100 ml of 1 mol / L hydrochloric acid solution was used as dissolution medium, rotating at RPM, operated according to law. At 45 minutes, appropriate solution was taken, filtered, and the appropriate amount of filtrate was continued, A solution containing about 25ug of cefradine per 1 ml was prepared by quantitative dilution with dissolution medium, and the absorbance was measured at the wavelength of 255mn by ultraviolet-visible spectrophotometry (General rule 0401); take the contents under the item of difference in loading amount, mix evenly, weigh the appropriate amount accurately (equivalent to the average loading amount), the solution containing cefradine 25ug per 1 ml was prepared by dissolving and quantitatively diluting according to the labeled amount and dissolution medium, filtered, and the filtrate was taken and determined by the same method, and the dissolution amount of each particle was calculated. The limit is 80% and shall be in accordance with the provisions.
- others should comply with the relevant provisions under the capsule (General 0103).
Content determination
take the contents under the difference of loading amount, mix evenly, accurately weigh the appropriate amount of fine powder (about 70mg equivalent to cefradine), put it in a 100ml measuring flask, and add 70ml of mobile phase, the cefradine was dissolved by noise, then diluted to the scale with mobile phase, shaken, filtered, and the filtrate was taken as the test solution, and determined according to the method of cefradine.
category
Same as cephradine.
specification
(1)0.125g (2)0.25g (3 )0.5g
storage
sealed, stored in the cool dark.
Last Update：2022-01-01 11:40:39
sq11436 - Cefradine granules
Authoritative Data Verified Data
This product contains cephradine (C14H19N304S) should be 90.0% to 110.0% of the label.
trait
This product is soluble particles or suspended particles; Gas fragrance.
identification
take an appropriate amount of this product, add water to dissolve and dilute to prepare a solution containing about 6mg of cefradine per 1 ml, filter, and take the continued filtrate as the test solution, the same results were shown for the identification tests (1) or (2) under cefradine.
examination
- acidity: take this product, add water to make a suspension containing cefradine 25mg per lml, and determine it according to law (General rule 0631). The pH value should be 3.5~6.0.
- taking cephalexin, preparing the test solution according to the method under the content determination item, and checking according to the method under the cefradine item, the content of cephalexin shall not exceed 6.0% of the total amount of cephradine and cephalexin.
- take an appropriate amount of water from this product and determine the water content according to the method of determination of water content (General rule 0832, first method 1). The water content shall not exceed 1.5%.
- dissolution of this product, according to the dissolution and release determination method (General 0931 second method), with 0.lmol/L hydrochloric acid solution 900ml as the dissolution medium, the rotation speed is 50 revolutions per minute, according to the operation, 45 minutes, take the appropriate amount of solution, filtration, precision take the appropriate amount of filtrate, with 0.1 mol/L hydrochloric acid solution is quantitatively diluted to prepare a solution containing about 28ug of cefradine per 1 ml as a test solution. 1 mol/L hydrochloric acid solution was dissolved and quantitatively diluted to prepare a solution containing about 28ug per 1 ml as a reference solution. The dissolution amount of each bag was calculated by the peak area according to the external standard method according to the method under the content determination of cefradine. 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
The contents under the difference of loading amount were extracted, ground finely and mixed evenly. An appropriate amount of fine powder (equivalent to cefradine 70mg) was accurately weighed, placed in a 100ml measuring flask, and 70ml of mobile phase was added, cefradine was dissolved by ultrasound, then diluted to the scale with mobile phase, shaken well, filtered, and the filtrate was taken as the test solution, which was obtained according to the method of cefradine.
category
Same as cephradine.
specification
(1)0.125g (2)0.25g
storage
sealed, stored in the cool dark.
Last Update：2022-01-01 11:40:40
sq11436 - Cefradine for injection
Authoritative Data Verified Data
This product is cefradine with an appropriate amount of cosolvent arginine made of sterile powder. The content of cephradine (C16H19N3O4S) shall not be less than 90.0% calculated based on anhydrous and arginine-free substances; The average content of cephradine (C16H19N304S) shall be 95.0%-115.0% of the labeled amount.
trait
This product is white or off-white 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
- alkalinity: take this product, add water to make a solution containing 0.lg of cefradine per 1 ml, and determine it according to law (General rule 0631). The pH value should be 8.0~9.6.
- the clarity and color of the solution take 5 bottles of this product and add water to make each lml containing cefradine 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).
- Cefalexin the contents of this product, mixed evenly, precision weighing to take appropriate amount, and mobile phase dissolved and quantitatively diluted to prepare a solution containing 0.7mg of cefradine per 1 ml, as a test solution; another 20mg Cefalexin reference product was weighed precisely, placed in a 50ml measuring flask, dissolved with water and diluted to the scale, then shaken well, and 5ml was weighed precisely, placed in a 50ml measuring flask, and diluted to the scale with water, shake well as a control solution. The content of cephradine and cephalexin should not exceed 6.0% of the total amount determined by the method described in the report of cephradine.
- Related substances the contents of this product are mixed evenly, and an appropriate amount is accurately weighed, dissolved and quantitatively diluted with mobile phase to prepare a solution containing 1 mg of cefradine per 1 ml, which is used as a test solution. According to the method under cefradine, the detection wavelength was 254nm. If there are impurity peaks in the chromatogram of the test solution, the 7-amino deacetoxycephalosporin acid shall be calculated by the external standard method based on the peak area except Cefalexin, and shall not exceed 1.0% of the labeled amount; the Peak area of other individual impurities shall not be more than 5 times (2.5%) of the main peak area of the control solution, and the sum of the peak areas of other impurities shall not be more than 6 times (3.0%) 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 5.0%, first method 1). The content uniformity of
- is calculated from the content of each bottle of cefradine measured under the content determination item, and should comply with the regulations (General 0941).
- insoluble particles the product is taken, and the solution containing 50mg of cefradine per 1 ml is prepared by adding water for particle inspection, and is inspected according to law (General rule 0903), and the labeled amount is l. The conversion below Og is that the particles containing 10um and 10um or more in each lg sample shall not exceed 6000, and the particles containing 25um and 25um or more shall not exceed 600. Label amount is l.Og or more (including l.Og) of each sample container containing 10um and more than lOum particles shall not exceed 6000, containing 25um and more than 25um particles shall not exceed 600.
- the bacterial endotoxin of this product is taken and checked according to law (General rule 1143). The amount of endotoxin per 1 mg cefradine should be less than 0.20EU.
- sterile take this product, dissolve and dilute with appropriate solvent, after the membrane filtration method, inspection according to law (General rule 1101), 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 with eighteen alkyl silane bonded silica as filler; With 0.O27mol/L sodium octane sulfonate 0.027mol/L disodium hydrogen phosphate solution (adjusted to pH 8.0 with phosphoric acid)-methanol (75:25) as mobile phase; The detection wavelength was 206nm. Take about 30mg of cefradine control, about 15mg of arginine control and 5mg of cephalexin control, put them in a 100ml measuring flask, add water to dissolve and dilute to the scale, shake well. 10u1 was injected into the liquid chromatograph, and the chromatogram was recorded. The separation degree between cephalexin peak and cephradine peak and cephradine peak and arginine peak should meet the requirements.
- determination of 10 bottles of this product, respectively, dissolved in water and quantitative dilution into each lml containing cefradine 0.3mg solution, as a test solution, the precision of 10u1 injection liquid chromatography, record the chromatogram. Take about 30mg of cefradine control and about 15mg of arginine control, put them in a 100ml measuring flask, dissolve them with water, dilute them to the scale, shake them well, and measure with the same method. The content of c14h19n3o4 s in each bottle was calculated by the peak area according to the external standard method. The average content of 10 bottles was determined. In addition, an appropriate amount of the content of this product is accurately weighed, dissolved with water and quantitatively diluted to prepare a solution containing 0.3mg of cefradine per lml. The content of c16h19n2o4 S and hc614n402 in the sample is calculated by the peak area according to the external standard method.
category
Same as cephradine.
specification
(1)0.5g (2)1.Og (3)2.Og
storage
sealed and kept in a cool dark place.
Last Update：2022-01-01 11:40:41
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Product Name: Cefradine Request for quotation
CAS: 38821-53-3
Tel: 0086-551-65418684
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Mobile: 0086 189 4982 3763
QQ: 2881500840
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CAS: 38821-53-3
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Product Name: Cefradine Visit Supplier Webpage Request for quotationCAS: 38821-53-3
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