Name | Cefadroxil |
Synonyms | cdx bl-s578 CEFAMOX bidocef Cefadroxil P-HYDROXYCEPHALEXINE Cefadroxil Anhydrous (6r-(6-alpha,7-beta(r*)))-l)acetyl)amino)-3-methyl-8-oxo 5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylicacid,7-((amino(4-hydroxypheny (6R,7R)-7-[(R)-2-AMINO-2-(4-HYDROXY-PHENYL)-ACETYLAMINO]-3-METHYL-8-OXO-5-THIA-1-AZA-BICYCLO[4.2.0]OCT-2-ENE-2-CARBOXYLIC ACID (6R,7R)-7-{[(2R)-2-amino-2-(4-hydroxyphenyl)acetyl]amino}-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid |
CAS | 50370-12-2 |
EINECS | 256-555-6 |
InChI | InChI=1/C16H17N3O5S/c1-7-6-25-15-11(14(22)19(15)12(7)16(23)24)18-13(21)10(17)8-2-4-9(20)5-3-8/h2-5,10-11,15,20H,6,17H2,1H3,(H,18,21)(H,23,24)/t10-,11-,15-/m1/s1 |
InChIKey | BOEGTKLJZSQCCD-UEKVPHQBSA-N |
Molecular Formula | C16H17N3O5S |
Molar Mass | 363.39 |
Density | 1.59 |
Melting Point | 197°C (rough estimate) |
Boling Point | 238°C (rough estimate) |
Flash Point | 431.5°C |
Vapor Presure | 2.71E-26mmHg at 25°C |
Appearance | powder or crystals |
pKa | 3.12±0.50(Predicted) |
Storage Condition | under inert gas (nitrogen or Argon) at 2–8 °C |
Refractive Index | 1.6390 (estimate) |
Physical and Chemical Properties | 66592-87-8 (monohydrate) |
Use | For Staphylococcus, Streptococcus, Pneumonia coccus, Escherichia coli and other urinary system, respiratory tract, skin, facial features and gastrointestinal tract infection treatment |
Hazard Symbols | Xn - Harmful![]() |
Risk Codes | R36/37/38 - Irritating to eyes, respiratory system and skin. R42/43 - May cause sensitization by inhalation and skin contact. |
Safety Description | S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S36 - Wear suitable protective clothing. |
WGK Germany | 2 |
RTECS | XI0337000 |
(6R,7R)-3-methyl -7-[(R)-2-amino -2-(4-hydroxyphenyl) acetamido]-8-oxo-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylic acid monohydrate. The content of cefadroxil (calculated as C16H17N3O5S) shall not be less than 95.0% calculated as anhydrous.
take this product, precision weighing, water dissolution and quantitative dilution of about 6mg per lml solution, according to the law (General 0621), specific rotation of 165 ° to 178 °.
take this product, according to the law inspection (General 0981), should comply with the provisions.
take this product, add water to make a solution containing 5mg per lml, according to the law (General 0631) ,pH value should be 4.0~6.0.
take an appropriate amount of this product, accurately weigh, add mobile phase A to dissolve and quantitatively dilute to prepare A solution containing about 1 mg per 1ml, as A test solution; Take 1ml for precision measurement, set in A 100ml measuring flask, dilute to the scale with mobile phase A, and shake to serve as A control solution. Accurately weigh about 10mg of a-p-hydroxyphenylglycine reference product, put it in A 10ml measuring flask, add appropriate amount of mobile phase a, ultrasonic dissolve and dilute to the scale, shake well, and use as reference solution (1); precisely weigh about 10mg of 7-aminodeacetoxycephalosporanic acid reference substance, put it in a 10ml measuring flask, and add phosphate buffer solution with pH 7.0 (take 28.4g of disodium hydrogen phosphate anhydrous, and add of water to dissolve the solution, adjust the pH to 30% with 7.0 phosphoric acid solution, dilute to ML with water, stick well) appropriate amount, ultrasonic dissolution and dilution to the scale, shake, as a control solution (2). 1ml of each of the control solution (1) and (2) was accurately measured, and the solution was placed in A 100ml measuring flask, diluted to the scale with mobile phase A, and shaken to obtain an impurity 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; Mobile phase A is 0.02mol/L potassium dihydrogen phosphate solution (2.72g of potassium dihydrogen phosphate, of water is added to dissolve, adjust the pH value to 5.0 with 1 mol/L potassium hydroxide solution, dilute to ML with water, mix well); Mobile phase B is fermentation; The detection wavelength is 220nm; Perform linear gradient elution according to the following table, 20ul of the mixed solution of the impurity reference solution and the test solution (9:1) is injected into the liquid chromatograph, and the chromatogram is recorded. The retention time of the cefadroxil peak is about 10 minutes, and the degree of separation between the-p-hydroxyphenylglycine peak and the aminodesacetoxycephalosporin acid peak should be greater than 5.0, the degree of separation between the peak of 7-aminodeacetoxycephalosporanic acid and the peak of cefadroxil should be greater than 5.0. The sample solution, the control solution and the impurity reference solution were accurately sampled at 20 u1, respectively injected into the human liquid chromatograph, and the chromatogram was recorded. If there are impurity peaks in the chromatogram of the test solution, P-hydroxyphenylglycine and 7-aminodesacetoxycephalosporinic acid shall not exceed 1.0% based on the peak area calculated by the external standard method; the Peak area of other individual impurities shall not be greater than the main peak area of the control solution (1.0% ) , and the sum of the peak areas of other impurities 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.
take this product, according to the moisture determination method (General 0832 first method 1), the moisture content should be 4.2% ~ 6.0%.
measured by high performance liquid chromatography (General 0512).
silica gel bonded with eighteen alkyl silane was used as the filler, and the mobile phase A- mobile phase B(98:2) under the item of related substances was used as the mobile phase. The detection wavelength was 230nm; take appropriate amount of cefadroxil reference and 7-aminodeacetoxycephalosporin acid reference, add appropriate amount of phosphate buffer pH 7.0 under the item of related substances, sonicate and dissolve, then diluted with 0.02mol/L potassium dihydrogen phosphate solution to make about 0.3mg and 0.lmg mixed solution, take lOul injection liquid chromatography, record chromatogram, cefadroxil peak and 7-amino deacetoxycephalosporin acid peak separation degree should be greater than 5.0.
take an appropriate amount of this product, precision weighing, add 0.02mol/L potassium dihydrogen phosphate solution to dissolve and quantitatively dilute to make a solution containing about 0.3mg per lml, as a test solution, 10 u1 was injected into the liquid chromatograph, and the chromatogram was recorded. An appropriate amount of cefadroxil reference was taken and determined by the same method. According to the external standard method to calculate the peak area, that is.
B-lactam antibiotics, cephalosporins.
shade, seal, and store in a cool place.
This product contains cefadroxil (according to C16H17N3O5S) should be 90.0% to 110.0% of the label amount.
This product is white or off-white.
Take 10 tablets of this product, precision weighing, fine grinding, precision weighing appropriate amount (about equivalent to cefadroxil, 0.15g according to C16H17N3O5S), and put it in a 100ml measuring flask, add 0.02mol/L potassium dihydrogen phosphate solution under cefadroxil to dissolve and dilute to scale, shake well, filter, take appropriate amount of filtrate, quantitatively dilute with the above 0.02mol/L potassium dihydrogen phosphate solution to prepare a solution containing about mg of cefadroxil (calculated as C16H17N3O5S) per 1 ml as a test solution, according to the method under the terms of cefadroxil, obtained.
Same as cefadroxil.
Based on C16H17N3O5S (1)0.125g (2)0.25g(3)0.5g
sealed and stored in a cool place.
This product contains cefadroxil (according to C16H17N305S) should be 90.0% ~ 110.0% of the label amount.
The contents of this product are white or off-white powder or granules.
take the contents under the difference of loading amount, mix them evenly, weigh appropriately (approximately equivalent to cefadroxil, 0.158 based on C16H17N305S), and place them in a 100ml measuring flask, add 0.02mol/L potassium dihydrogen phosphate solution of cefadroxil to dissolve and dilute to the scale, shake well, filter, take proper amount of filtrate, quantitatively dilute with the above 0.02mol/L potassium dihydrogen phosphate solution to prepare a solution containing about mg of cefadroxil (calculated as C16H17N305S) per 1 ml as a test solution, according to the method under the terms of cefadroxil, obtained.
Same as cefadroxil.
Based on C16H17N305S (l)0.125g (2)0.25g(3)0.5g
light shielding, sealed, stored in the cool dark.
This product contains cefadroxil (according to C16H17N305S) should be 90.0% ~ 110.0% of the label amount.
This product is soluble granules; Sweet taste.
take the contents under the difference of loading amount, grind them finely, weigh appropriately (about 0.15g equivalent to cefadroxil, based on C16H17N305S), and place them in lOOml measuring flask, add 0.02mol/L potassium dihydrogen phosphate solution under the related substances of cefadroxil to dissolve and dilute to the scale, shake well, filter, accurately take appropriate amount of filtrate, add the above 0.02mol/L potassium dihydrogen phosphate solution to make a solution containing about mg of cefadroxil (calculated as C16H17N305S) per 1 ml, as a test solution, according to the method under the terms of cefadroxil, obtained.
Same as cefadroxil.
Based on C16H17N305S (1)0.125g (2)0.25g
sealed and stored in a cool place.