CEFPROZIL
Cefprozil
CAS: 92665-29-7;121123-17-9
Molecular Formula: C18H19N3O5S
CEFPROZIL - Names and Identifiers
CEFPROZIL - Physico-chemical Properties
| Molecular Formula | C18H19N3O5S |
| Molar Mass | 389.43 |
| Density | 1.53±0.1 g/cm3(Predicted) |
| Melting Point | 215-217°C (dec.) |
| Boling Point | 803℃ |
| Flash Point | >110°(230°F) |
| Water Solubility | Soluble in DMSO at 10mg/ml. Insoluble in water. |
| Vapor Presure | 0mmHg at 25°C |
| Appearance | Powder |
| pKa | 2.92±0.50(Predicted) |
| Storage Condition | Keep in dark place,Inert atmosphere,Store in freezer, under -20°C |
| Refractive Index | 1.718 |
| Use | Second-generation cephalosporin antibiotics, with broad-spectrum antibacterial effect |
CEFPROZIL - Risk and Safety
| RTECS | XI0339000 |
CEFPROZIL - Standard
Authoritative Data Verified Data
(6R,7R)-3-propenyl-7-[(K)-2-amino -2-(4-hydroxy-3-yl) acetamido]-8-oxo-5-thia-1-azabicyclo [4. 2.0] caprylic -2-pain carboxylic acid monohydrate. The content of cefprozil (calculated as C18H19N305S) shall be between 90.0% and 105.0% based on the anhydrous content.
Last Update：2024-01-02 23:10:35
CEFPROZIL - Trait
Authoritative Data Verified Data
- This product is white to light yellow crystalline powder.
- This product is slightly soluble in water; fi soluble in methanol or N ,N-N-dimethylformamide; Almost insoluble in acetone or ether.
Last Update：2022-01-01 11:39:22
CEFPROZIL - Differential diagnosis
Authoritative Data Verified Data
- in the chromatogram recorded under the content determination item, the retention time of the two main peaks in the Test occupied solution should be different from (Z) peak and (E) peak in the control solution, respectively the retention times of the isomer peaks were consistent.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 1).
Last Update：2022-01-01 11:39:23
CEFPROZIL - Exam
Authoritative Data Verified Data
crystallinity
take this product, inspection according to law (General 0981), should be prescribed.
acidity
take 0.5g of this product, add 100ml of water to dissolve, and measure according to law (General rule 0631). The pH value should be 3.5~6.5.
cefprozil (E) isomer
take this product, according to the content determination under the item of determination, cefprozil (E) isomer content and cefprozil (Z), (E) the amount and ratio of the isomeric energization should be 0.06 to 0.11.
Related substances
accurately weigh 75mg of this product, put it in a measuring flask, add [0.23% ammonium dihydrogen phosphate solution-methanol (94:6)] to dissolve and dilute it for 3 degrees, shake it well, as a test solution; Take 1ml of precision measurement, put 100ml measuring flask with the above solvent diluted to the scale, shake, as a control solution; Precision measurement, A solution containing about 0.375ug per 1ml was prepared by quantitative dilution with the above solvent as a sensitivity solution, A solution containing 7.5ug per 1ml was prepared by adding 3 doses of dissolution and quantitative dilution as the control solution of the polyamoxicillin. According to high performance liquid chromatography (General 0512), silica gel bonded with eighteen alkyl silane was used as filler; Mobile phase A was 0.23 oligomeric ammonium dihydrogen solution, mobile phase B was methanol; Flow rate was 1 per minute. OmUS table for linear gradient elution, the detection wavelength was 225nm. The retention time of cefprozil structure is about 23~30 minutes, the retention time of cefprozil isomer is about 30~40 minutes, cefprozil (2) the degree of separation between the isomer peak and the phase quality peak shall meet the requirements. Take the sensitivity of solution 20H1, injection of aluminum chromatography, cefprozil (Z) isomer peak high signal-to-noise ratio should be greater than 10. The test solution, the control solution and the cefadroxil reference substance solution box 20 u1 are injected into the human liquid chromatograph respectively, and the chromatogram ^ If there are impurity peaks in the chromatogram of the test solution, the Peak area of cefadroxil shall be calculated according to the external standard method, and shall not exceed 0.5%; The peak area of other single impurities shall not be greater than the cefprozil (Z) isomer and (E) in the control solution. 0.3 times (0.3%) of the sum of the peak areas of isomers; The sum of the peak areas of other impurities shall not be greater than 1.0 times (1.0%) of the sum of the peak areas of cefprozil (Z) isomer and (E) isomer in the control solution; the peaks in the chromatogram of the test solution which are smaller than the main peak area of the sensitivity solution are ignored.
residual solvent
acetone, isopropyl alcohol, two gas methane, ethyl acetate and butyl acetate take this product about 50mg, precision weighing, top empty bottle, precision add water 5ml to dissolve, sealed, as a test solution. Accurately weigh the appropriate amount of acetone, isopropanol, dichloromethane, ethyl acetate and butyl acetate respectively, and make them quantitatively diluted with water to contain about 50ug of acetone, isopropanol, ethyl acetate and butyl acetate respectively per 1 ml, 5ml of the mixed solution of methylene chloride was accurately measured, placed in a headspace bottle, sealed, and used as a reference solution. According to the determination method of residual solvent (General Principle 0861 second method), the capillary column with 6% cyanopropyl phenyl-94% dimethyl polysiloxane (or similar polar) as stationary liquid is used as the column, and the initial temperature is 40°C, maintain for 7 minutes, at the rate of 208C per minute to 100°C, maintain for 7 minutes, and then at the rate of 25BC per minute to 220°C, maintain for 5 minutes; The detector temperature is 250°C; the inlet temperature was 200°C; The headspace bottle equilibration temperature was 80°C and the equilibration time was 30 minutes. Take the reference solution into the headspace, the separation degree of each peak should meet the requirements. The test solution and the reference solution were injected by Headspace, and the chromatograms were recorded. The peak area shall be calculated according to the external standard method and shall comply with the regulations.
N,N-dimethylformamide
take about 0.5g of this product, weigh it accurately, place it in the top empty bottle, add 2ml of 1, 3-dimethylimidazolidinone to dissolve it, seal it, and use it as a test solution. Take an appropriate amount of N, N-dimethylformamide and N, N-dimethylacetamide, and dilute with 1, 3-dimethylimidazolidinone to prepare a solution containing about 0.2mg each in 1 ml, and take 2ml with precision, in the top empty bottle, sealed, as the resolution solution; Precision weighing an appropriate amount of dimethylformamide, plus 1, 3-dimethylimidazolidinone quantitative dilution to make a solution containing about 0.2mg per 1 ml, precision taking 2ml, top empty bottle, sealed, as a control solution. According to the determination method of residual solvent (General Principle 0861 second method), the capillary column with 6% cyanopropyl phenyl-94% dimethyl polysiloxane (or similar polar) as stationary liquid is used as the column, and the initial temperature is 100°C, maintain 8 minutes, at a rate of 20°C per minute to 230°C, maintain 5 minutes t detector temperature of 250°C; Injection port temperature of 200°C; Headspace bottle equilibrium temperature of 90°C, the equilibration time was 30 minutes. Separation degree solution headspace injection, N ,
The resolution between the N-dimethylformamide peak and the N, N-dimethylacetamide peak shall be satisfactory. The test solution and the reference solution were injected by Headspace, and the chromatograms were recorded. According to the external standard method to calculate the peak area, should comply with the provisions.
moisture
take this product, according to the moisture determination method (General 0832 first method 1), the moisture content should be 3.5% ~ 6.5%.
Last Update：2022-01-01 11:39:24
CEFPROZIL - Content determination
Authoritative Data Verified Data
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
silica gel bonded with OCTA alkyl silane as filler; Ammonium dihydrogen phosphate solution (20.7g of ammonium dihydrogen phosphate, 1800ml of water to dissolve, adjust pH value to 4.4 with phosphoric acid)-acetonitrile (90:10) mobile phase; The detection wavelength was 280nm. About 2.5mg cefprozil was added into a 25ml measuring flask, dissolved with water and diluted to the scale. After shaking, 10u1 was injected into HPLC and the chromatogram was recorded. The resolution between the cefprozil (Z) isomer peak and the (E) isomer peak should be greater than 2.5.
assay
take about 30mg of this product, weigh it accurately, put it in a 100ml measuring flask, add an appropriate amount of water, fully shake to dissolve, dilute it with water to the scale, shake it well, and use it as a test solution, A 10ul injection liquid chromatograph was used for precision measurement, and the chromatogram was recorded. An appropriate amount of cefprozil reference substance was used for precision measurement, and the same method was used for determination. Calculate the content of cefprozil (based on C18H19N3O5S)(z) isomer and cefprozil (based on C18H13N305S)(E) isomer by peak area according to external standard method, the sum of the two is the content of cefprozil (based on C18H19N3O5S) in the test product.
Last Update：2022-01-01 11:39:25
CEFPROZIL - Category
Authoritative Data Verified Data
B-lactam antibiotics, cephalosporins.
Last Update：2022-01-01 11:39:25
CEFPROZIL - Storage
Authoritative Data Verified Data
sealed storage.
Last Update：2022-01-01 11:39:25
CEFPROZIL - Cefprozil dry suspension
Authoritative Data Verified Data
This product contains cefprozil (based on C18H19N305S) should be 90.0% to 120.0% of the label amount.
trait
This product is granular or powder; Aromatic.
identification
- (1) take an appropriate amount of fine powder of this product and add 0.1 mol/L hydrochloric acid solution-acetone (1:4) mixed solution was dissolved and diluted to prepare a solution containing about 2.5mg of cefprozil (calculated as C18H19N305S) per 1 ml, filtered, take the continued filtrate as the test solution; Take the appropriate amount of cefprozil reference, add 0. A 1 mol/L hydrochloric acid solution-acetone (1:4) mixed solution was dissolved and diluted to give a solution containing about 2.5mg per 1 ml as a control solution. According to the thin layer chromatography (General 0502) test, absorb 10 u1 of each of the above two solutions, respectively point on the same silica gel G thin layer plate [after activation at 105°C for 1 hour, in 5%(ml/ml) n-hexane solution of N-decane, spread to the top of the thin layer plate and dry it, with 0.1mol/L hydrochloric acid solution -0.2mol/L disodium hydrogen phosphate solution-acetone (60:40:1.5) as the developing solvent, after expansion, heated at 105 ° C. For 5 minutes, A 0.1% ninhydrin solution prepared with the developing solvent was sprayed immediately and heated at 105°C for 15 minutes. 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 of the reference solution.
- (2) in the chromatogram recorded under the content determination item, the retention time of the two main peaks in the test solution should be the same as that of the (Z) isomer peak and (E) in the control solution. The retention times of the isomer peaks were consistent.
- two items (1) and (2) above can be selected as one item.
examination
- cefprozil (K) isomer this product was taken and determined according to the method under the content determination item, the content of cefprozil (E) isomer and cefprozil U )(E) the isomer content and the ratio should be 0.06 to 0.11.
- acidity: take an appropriate amount of the contents of this product and add water to make a suspension containing cefprozil (according to (C18H19N305S) 35 beer per lml, and determine it according to law (General rule 0631). The pH value should be 4.0~6.0.
- appropriate amount of contents (about 75mg equivalent to cefprozil, based on c18h19n305 s) under the item of difference in precision weighing and loading of related substances, add the solvent [0.23% ammonium dihydrogen phosphate solution-methanol (94:6)] to dissolve and dilute to dryness, shake well, filter, and take the continued filtrate as the test solution, the determination was carried out according to the method described under cefprozil. The Peak area of cefadroxil shall be calculated according to the external standard method, and the peak area of other single impurities shall not exceed 0.5% of the labeled amount; The peak area of cefprozil (Z) in the control solution shall not be greater isomer and (E isomer 0.5 times the sum of the peak area (0.5% ) ; Other impurities and peak area shall not be greater than the control solution cefprozil (Z) isomer and (E) 1.5 times (1.5%) the sum of isomer peak areas.
- the moisture content of this product shall not exceed 0832 as determined by the method for determination of moisture (General rule 3.0%, first method 1).
- the dissolution of this product, according to the dissolution and release determination method (General 0931 second method), water 900ml as the dissolution medium, the speed of 75 rpm, according to the law. After 30 minutes, the appropriate amount of the solution was filtered, and the filtrate was taken as the test solution. In addition, the appropriate amount of cefprozil reference substance was taken, dissolved with water and quantitatively diluted to make 0.28mg(0.5g specification, 0.25g specification) or 0.14mg(0.125g specification) solution, as a control solution. Take the above two kinds of solution, according to the method under the content determination item, calculate the dissolution amount of each package. The limit is 80% of the labeled amount and shall be in accordance with the provisions.
- In addition to the sedimentation volume ratio (single dose package), the other should comply with the relevant provisions under the item of oral suspension (General Principle 0123).
inclusion assay
take the contents under the difference of loading amount, mix them evenly, weigh an appropriate amount (about equivalent to cefprozil, 0.25g according to C18H19N30 5S) precisely, and place it in a 250ml measuring flask, add about 150ml of water, shake, ultrasonic to dissolve cefprozil, dilute to scale with water, shake, filter, take appropriate amount of filtrate with precision, prepare about cefprozil (based on C18H19N3OsS) per lm I by quantitative dilution with water. 3mg of solution, as a test solution, according to the method under the item of cefprozil, that is obtained.
category
Same as cefprozil.
specification
Based on C18H19N305S (1)0.125g (2)0.25g(3)0.5g
storage
shade, seal, and store in a cool and dry place.
Last Update：2022-01-01 11:39:26
CEFPROZIL - Cefprozil Tablets
Authoritative Data Verified Data
This product contains cefprozil (based on C18H19N305S) should be 90.0% to 110.0% of the label amount.
trait
This product is a film-coated tablet, white to light yellow after removing the coating.
identification
- take an appropriate amount of fine powder of this product and add 0.1 mol/L hydrochloric acid solution-acetone (1:4) mixed solution was dissolved and diluted to prepare a solution containing about 2.5mg of cefprozil (calculated as C18H19N305S) per 1 ml, filtered, take the continued filtrate as the test solution; Take the appropriate amount of cefprozil reference, add 0. A 1 mol/L hydrochloric acid solution-acetone (1:4) mixed solution was dissolved and diluted to give a solution containing about 2.5mg per 1 ml as a control solution. According to the thin layer chromatography (General 0502) test, absorb 10 u1 of each of the above two solutions, respectively point on the same silica gel G thin layer plate [after activation at 105°C for 1 hour, 5%(ml/ml) n-hexane solution of N-decane, spread to the top of the thin layer plate, dry on], 0.1 mol/L citric acid solution -0.2mol/L disodium hydrogen phosphate solution-acetone (60:40:1.5) as the developing solvent, after expansion, heated at 105°C for 5 minutes, A 0.1% ninhydrin solution prepared with the developing solvent was sprayed immediately and heated at 105°C for 15 minutes. 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 of the reference solution.
- in the chromatogram recorded under the content determination item, the retention time of the two main peaks in the test solution should be the same as that of the (Z) isomer peak and (E) in the control solution. The retention times of the isomer peaks were consistent.
- two items (1) and (2) above can be selected as one item.
examination
- cefprozil (E) isomer this product was taken and determined according to the method under the content determination item, the content of cefprozil (E) isomer and cefprozil (Z), (E) the isomer content and the ratio should be 0.06 to 0.11.
- Related substances precise weighing appropriate amount of fine powder of this product (about equivalent to cefprozil, 75mg as per (C18H19N305S), put it in a 100ml measuring flask, add solvent [0.23% ammonium dihydrogen phosphate solution-methanol (94:6 )] dissolve and dilute to the scale, shake, filter
- then, the filtrate was taken as a test solution and measured according to the method described in the case of cefprozil. The Peak area of cefadroxil shall be calculated according to the external standard method, and shall not exceed 0.5% of the labeled amount; The peak area of other individual impurities shall not be greater than the cefprozil (Z) isomer and (E) in the control solution. 0.5 times (0.5%) of the sum of the peak areas of isomers; The sum of the peak areas of other impurities shall not be greater than 1.5 times (1.5%) of the sum of the peak areas of cefprozil (2) isomer and (E) isomer in the control solution.
- the moisture content of this product shall not exceed 0832 as determined by the method for determination of moisture (General rule 7.0%, first method 1).
- the dissolution of this product, according to the dissolution and release determination method (General rule 0931 The first method), water 900ml as the dissolution medium, the speed of 75 rpm, according to the law. After 30 minutes, take an appropriate amount of the solution, filter, and take the filtrate as the test solution; Take an appropriate amount of cefprozil reference substance, add water to dissolve and quantitatively dilute to make a solution containing about 0.28mg per 1 ml, as a control solution. Take the above two kinds of solution, according to the method under the content determination item, calculate the dissolution amount of each tablet. The limit is 80% of the labeled amount 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 grinding, precision weighing appropriate amount (about equivalent to cefprozil, 0.25g according to C18H19N305S), put it in a 250ml measuring flask, add water about 150ml, shake, ultrasonic to dissolve cefprozil, dilute to the scale with water, shake well, filter, take the appropriate amount of filtrate accurately, and dilute quantitatively with water to make about cefprozil per lm l (based on C18H19N305S) 0.3mg of the solution was obtained as a test solution by measurement according to the method described in the case of cefprozil.
category
Same as cefprozil.
specification
Based on C18H19N305S (1)0.25g (2)0.5g
storage
shade, seal, and store in a cool and dry place.
Last Update：2022-01-01 11:39:27
CEFPROZIL - Cefprozil Capsules
Authoritative Data Verified Data
This product contains cefprozil (based on C18H19N305S) should be 90.0% to 110.0% of the label amount.
trait
The content of this product is white to light yellow particles or powder.
identification
- take an appropriate amount of the contents of this product and add 0.1 mol/L hydrochloric acid solution-acetone (1:4) mixed solution was dissolved and diluted to prepare a solution containing about 2.5mg of cefprozil (based on C18H19N305S) per 1 ml, filtered, continue the filtrate as the test solution; Take the appropriate amount of cefprozil control, add 0. A 1 mol/L hydrochloric acid solution-acetone (1:4) mixed solution was dissolved and diluted to give a solution containing about 2.5mg per 1 ml as a control solution. According to the thin layer chromatography (General 0502) test, absorb 10U1 of each of the above two solutions, respectively point on the same silica gel G thin layer plate [after activation at 105°C for 1 hour, 5%(ml/ml) n-hexane solution of N-decane, spread to the top of the thin layer plate, dry on], 0.1 mol/L citric acid solution -0.2mol/L disodium hydrogen phosphate solution-acetone (60:40:1.5) as the developing solvent, after expansion, heated at 105°C for 5 minutes, A 0.1% ninhydrin solution prepared with the developing solvent was sprayed immediately and heated at 105°C for 15 minutes. 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 of the reference solution.
- in the chromatogram recorded under the content determination item, the retention time of the two main peaks in the test solution should be the same as that of the (Z) isomer peak and (E) in the control solution. The retention times of the isomer peaks were consistent.
- two items (1) and (2) above can be selected as one item.
examination
- cefprozil (E) isomer this product was taken and determined according to the method under the content determination item, the content of cefprozil (E) isomer and cefprozil (2), (E) the isomer content and the ratio should be 0.06 to 0.11.
- appropriate amount of contents (about 75mg equivalent to cefprozil, based on C18H19N3O5S) under the item of difference in precision weighing and loading of related substances, add the solvent [0.23% ammonium dihydrogen phosphate solution-methanol (94:6)] to dissolve and dilute to the scale, shake, filter, and take the continued filtrate as the test solution, the determination was carried out according to the method described under cefprozil. The Peak area of cefadroxil shall be calculated according to the external standard method, and shall not exceed 0.5% of the labeled amount; The peak area of other individual impurities shall not be greater than the cefprozil (Z) isomer and (E) in the control solution. 0.5 times (0.5%) of the sum of the peak areas of isomers; The sum of the peak areas of other impurities shall not be greater than 1.5 times (1.5%) of the sum of the peak areas of cefprozil (Z) isomer and (E) isomer in the control solution.
- the moisture content of this product shall not exceed 0832 as determined by the method for determination of moisture (General rule 7.0%, first method 1).
- the dissolution of this product, according to the dissolution and release determination method (General rule 0931 The first method), water 900ml as the dissolution medium, the speed of 75 rpm, according to the law. After 30 minutes, take the appropriate amount of the solution, filter, and take the filtrate as the test solution; Take the appropriate amount of cefprozil reference, add water to dissolve and quantitatively dilute to make 0.28mg(0.25g specification) per 1 ml. Or 0.14mg(0.125g specification) solution, as a control solution. Take the above two kinds of solution, according to the method under the content determination item, calculate the dissolution amount of each grain. 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 capsule (General 0103).
Content determination
take the contents under the difference of loading amount, mix them evenly, weigh an appropriate amount (about equivalent to cefprozil, 0.25g according to (C18H19N305S)) precisely, and place it in a 250ml measuring flask, add about 150ml of water, shake, ultrasonic to dissolve cefprozil, dilute to scale with water, shake, filter, take appropriate amount of filtrate with precision, A solution containing about 0.3mg of cefprozil (based on C18H19N305S) per 1 ml was prepared by quantitative dilution with water as a test solution, which was determined according to the method under cefprozil.
category
Same as cefprozil.
specification
Based on C18H19N305S (1)0.125g (2)0.25g
storage
shade, seal, and store in a cool and dry place.
Last Update：2022-01-01 11:39:28
CEFPROZIL - Cefprozil Granules
Authoritative Data Verified Data
This product contains cefprozil (based on C18H19N305S) should be 90.0% to 110.0% of the label amount.
trait
This product is granular or powder, aromatic.
identification
- take an appropriate amount of the contents of this product and add 0.1 mol/L hydrochloric acid solution-acetone (1:4) mixed solution was dissolved and diluted to prepare a solution containing about 2.5mg of cefprozil (based on C18H19N3O5S) per 1 ml, filtered, take the continued filtrate as the test solution; Take the appropriate amount of cefprozil reference, add 0. A 1 mol/L hydrochloric acid solution-acetone (1:4) mixed solution was dissolved and diluted to give a solution containing about 2.5mg per 1 ml as a control solution. According to the thin layer chromatography (General 0502) test, absorb 10MU of each of the above two solutions and point them on the same silica gel G thin layer plate [after being activated at 105°C for 1 hour, 5%(ml/ml) n-hexane solution of N-decane, spread to the top of the thin layer plate, dry on], 0.1 mol/L citric acid solution -0.2mol/L disodium hydrogen phosphate solution-acetone (60:40:1.5) as the developing solvent, after expansion, heated at 105°C for 5 minutes, A 0.1% ninhydrin solution prepared with the developing solvent was sprayed immediately and heated at 105°C for 15 minutes. 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 of the reference solution.
- in the chromatogram recorded under the content determination item, the retention time of the two main peaks in the test solution should be the same as that of the (Z) isomer peak and (E) in the control solution. The retention times of the isomer peaks were consistent.
- two items (1) and (2) above can be selected as one item.
examination
- cefprozil (E) isomer this product was taken and determined according to the method under the content determination item, the content of cefprozil (E) isomer and cefprozil (Z), (E) the isomer content and the ratio should be 0.06 to 0.11.
- acidity: take an appropriate amount of the contents of this product, add water to make a suspension containing about 5mg of cefprozil (based on C18H19N305S) per 1 ml, and determine it according to law (General rule 0631). The pH value should be 4.0~6.0.
- the appropriate amount of the content under the difference in the precision weighing of the related substances (about 75mg equivalent to cefprozil, based on c18h19n305 S) is placed in a 100ml measuring flask, add the solvent [0.23% ammonium dihydrogen phosphate solution-methanol (94:6 )] to dissolve and dilute to the scale, shake, filter, and take the continued filtrate as the test solution, the determination was carried out according to the method described under cefprozil. The Peak area of cefadroxil shall be calculated according to the external standard method, and shall not exceed 0.5% of the labeled amount; The peak area of other individual impurities shall not be greater than the cefprozil (Z) isomer and (E) in the control solution. 0.5 times (0.5%) of the sum of the peak areas of isomers; The sum of the peak areas of other impurities shall not be greater than 1.5 times (1.5%) of the sum of the peak areas of cefprozil (Z) isomer and (E) isomer in the control solution.
- the moisture content of this product shall not exceed 0832 as determined by the method for determination of moisture (General rule 3.0%, first method 1).
- the dissolution of this product, according to the dissolution and release determination method (General rule 0931 second method>, water 900ml as the dissolution medium, the rotation speed of 75 rpm, according to the law. After 30 minutes, take the appropriate amount of the solution, filter, and take the filtrate as the test solution; Take the appropriate amount of cefprozil reference, add water to dissolve and quantitatively dilute to make 0.28mg(0.25g specification) per 1 ml. Or 0.14mg(0.125g specification) solution, as a control solution. Take the above two kinds of solution, according to the method under the content determination item, calculate the dissolution amount of each package. 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
take the contents under the difference of loading amount, mix them evenly, weigh an appropriate amount (approximately equivalent to 0.25g of cefprozil, based on C18H19N305S), put it in a 250ml measuring flask, and add about 150ml of water, shake, ultrasonic to dissolve cefprozil, dilute to scale with water, shake well, filter, take the appropriate amount of filtrate accurately, and dilute quantitatively with water to make about cefprozil (based on C18H19N305S) per lml. 0.3mg of the solution was obtained as a test solution by measurement according to the method described in the case of cefprozil.
category
Same as cefprozil.
specification
Based on C18H19N305S (l)0.125g (2)0.25g
storage
shade, seal, and store in a cool and dry place.
Last Update：2022-01-01 11:39:29
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