Faropenem sodium
faropenem sodium
CAS: 122547-49-3
Molecular Formula: C12H14NO5S.Na
Faropenem sodium - Names and Identifiers
Faropenem sodium - Physico-chemical Properties
| Molecular Formula | C12H14NO5S.Na |
| Molar Mass | 307.3 |
| Melting Point | >85°C (dec.) |
| Boling Point | 570.2°C at 760 mmHg |
| Specific Rotation(α) | D22 +60° (c = 0.10) |
| Flash Point | 298.7°C |
| Solubility | H2O: ≥20mg/mL |
| Vapor Presure | 2.23E-15mmHg at 25°C |
| Appearance | powder |
| Color | white to light brown |
| Storage Condition | -20°C |
| Stability | Hygroscopic |
Faropenem sodium - Risk and Safety
| WGK Germany | 3 |
Faropenem sodium - Standard
Authoritative Data Verified Data
This product is (5R,6S ) -6 - [( lR ) -l-Hydroxyethyl] -7-oxo-3-[(2R)-Tetrahydrofuran-2-yl]-4-thia-1-azabicyclo [3.2.0] hept-2-ene-2-carboxylic acid sodium salt dihemihydrate. The content of faropenem (C12H15N05S) should be 90.0% to 94.3% based on the calculation of water-free and solvent-free substances.
Last Update：2024-01-02 23:10:35
Faropenem sodium - Trait
Authoritative Data Verified Data
- This product is white to light yellow crystal or crystalline powder; Odorless or slightly special odor.
- This product is soluble in water or methanol; Slightly soluble in ethanol, almost insoluble in ethyl acetate.
specific rotation
take this product, precision weigh, add water to dissolve and quantitatively dilute to make a solution containing 10mg of faropenem per lml, and determine it according to law (General rule 0621), the specific rotation was 145 ° to 150 °.
Last Update：2022-01-01 13:37:49
Faropenem sodium - Preparation solution concentration reference
| 1mg | 5mg | 10mg | |
|---|---|---|---|
| 1 mM | 3.254 ml | 16.271 ml | 32.542 ml |
| 5 mM | 0.651 ml | 3.254 ml | 6.508 ml |
| 10 mM | 0.325 ml | 1.627 ml | 3.254 ml |
| 5 mM | 0.065 ml | 0.325 ml | 0.651 ml |
Last Update：2024-01-02 23:10:35
Faropenem sodium - Differential diagnosis
Authoritative Data Verified Data
- take about 10mg of this product, add hydroxylamine hydrochloride solution lml to dissolve, after standing for 3 minutes, add acid ammonium ferric sulfate solution lml, shake, the solution shows red-brown or black color.
- 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 water to dissolve and dilute to prepare a solution containing about 36ug faropenem per lml, and measure it by UV-Vis spectrophotometry (General rule 0401), there is a maximum absorption at a wavelength of 256Nm and 306nm, and a minimum absorption at a wavelength of 236nm.
- The infrared absorption spectrum of this product should be consistent with that of the reference substance (General rule 0402).
- This product shows the reaction of sodium salt identification (1) (General rule 0301).
Last Update：2022-01-01 13:37:50
Faropenem sodium - Exam
Authoritative Data Verified Data
acidity
take 0.lg of this product, add 10ml of water to dissolve, and measure according to law (General rule 0631). The pH value should be 5.0~7.0.
clarity and color of solution
take 5 parts of this product, each 0.2g, respectively, and add 10ml of water to dissolve, the solution should be clear and colorless; If it is turbid, compare it 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 No. 2 Standard Colorimetric solution (General Principles 0901 first method).
Related substances I
new system for clinical use. Take this product, add phosphate buffer (take potassium dihydrogen phosphate 4.8g, disodium hydrogen phosphate 5.4g and tetrabutylammonium bromide l. Add water, dissolve and dilute to 1000ml, Shake)-acetonitrile (85:15) mixed solution (solvent I) to dissolve and dilute to make a solution containing about 0.5mg of faropenem per 1 ml, as a test solution; Take 1 ml with precision, put it in a 100ml measuring flask, dilute it to the scale with solvent I, shake it, and use it as a control solution; Take an appropriate amount of control solution with precision, A solution containing about 0.25ug of faropenem per 1 ml was prepared as a sensitivity solution by quantitative dilution with solvent I. According to the high performance liquid chromatography (General rule 0512) test, using eighteen alkyl silane bonded silica gel as filler (4.6mm X, 5um or performance equivalent column); mobile phase A was phosphate buffer (6.12g of potassium dihydrogen phosphate, 1.79g of disodium hydrogen phosphate and 1.61g of tetrabutylammonium bromide were dissolved and diluted with water to make 1000ml); Mobile phase B was phosphate buffer-acetonitrile (50:50); The flow rate is 1.0ml per minute; The following table is linear gradient elution; The column temperature is 40 C; The detection wavelength is 240nm. Take appropriate amount of faropenem reference substance and impurity I reference substance, add solvent I to dissolve and dilute to make a mixed solution containing about 0.25mg of each lml, take 20u1 to inject human liquid chromatograph, record chromatogram, the retention time of the South Peak of faropenem is about 31 minutes, and the degree of separation between the South Peak of faropenem and the peak of impurity I should meet the requirements. The sensitivity solution 20ul is injected into the liquid chromatograph, and the signal-to-noise ratio of the peak peak is higher than 10. Then, 20ul of the test solution and the control solution are respectively injected into the liquid chromatograph, and the chromatograms are recorded. If there are impurity peaks in the chromatogram of the test solution, the peak area of impurity I 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 0.15 times (0.15%) of the main peak area of the control solution, and the sum of other impurity peak areas shall not be greater than 0.5 times (0.5%) of the main peak area of 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.
Related substances II
new system for clinical use. Take an appropriate amount of this product, precision weighing, adding water to dissolve and quantitatively dilute to prepare a solution containing about 1 mg of faropenem per 1 ml, as a test solution; Take an appropriate amount of faropenem reference, precision weighing, water was added to dissolve and quantitatively diluted to prepare a solution containing about 10ug per 1 ml as a control solution; An appropriate amount was taken in a precise amount and quantitatively diluted with water to prepare a solution containing about 0.5ug per 1 ml as a sensitivity solution. Determined by size exclusion chromatography (General 0514). Use spherical hydrophilic silica gel (molecular weight range of dextran 1000~30000) as filler (7.5mm X 300mm ,10um or equivalent chromatography column); Phosphate buffer (pH 7.0 ) [0.005mol/L disodium hydrogen phosphate solution -0.005mol/L sodium dihydrogen phosphate solution (61:39)]-acetonitrile (95:5) as mobile phase, the flow rate was 0.6 per minute, the detection wavelength was 220nm. An appropriate amount of the sample solution was taken, heated in a water bath at 75 ° C. For 10 minutes, cooled, and injected into a liquid chromatograph at 20m1, and the chromatogram was recorded. The resolution between the South Peak of faropei and the peak of the degradation product with the relative retention time of about 0.85 should meet the requirements. Take the sensitivity of the solution 20 u1, injection of human liquid chromatography, the signal to noise ratio of the main component chromatographic peak height should be greater than 10. Then, 20 u1 of the test solution and the control solution are respectively injected into the liquid chromatograph, and the chromatograms are recorded. If there are impurity peaks in the chromatogram of the test solution, the total amount of impurities with retention time less than that of faropei South Peak shall not exceed 1.0% calculated by external standard method.
residual solvent
take this product about 1.0G, precision weighing, set in the top empty bottle, Precision Add dimethyl sulfoxide 5ml to dissolve, seal, as a test solution; Respectively, precision weighing n-hexane, acetone, tetrahydrofuran, dichloromethane, acetonitrile, toluene and xylene were quantitatively diluted with dimethyl sulfoxide to prepare 0.058mg of hexane, 1.0 mg of acetone, 0.144mg of Tetrahydropyran, 0.12mg of dichloromethane per 1 ml, respectively, 5ml of a mixed solution of 0.082mg of acetonitrile, 0.178mg of toluene and 0.434mg of xylene was precisely weighed, placed in a headspace bottle, sealed, and used as a reference solution. According to the test for determination of residual solvents (General rule 0861, second method), the capillary column with polyethylene glycol (or similar polarity) as stationary liquid is used as the chromatographic column, and the initial temperature is 30 ° C. For 15 minutes, then the temperature was increased to 150°C at a rate of 50°C per minute for 5 minutes; The inlet temperature was 170°C; The detector temperature was 200°C; The equilibrium temperature of the headspace bottle was 80°C, the equilibration time was 30 minutes. Take the reference solution into the headspace, elution according to the order of n-hexane, acetone, Tetrahydrofuran, dichloromethane, acetonitrile, toluene, xylene, dimethyl sulfoxide (solvent), the degree of separation between the main peaks shall be in accordance with the requirements ^ samples of the test solution and the reference solution are injected in Headspace respectively, the chromatogram is recorded, and the peak area is calculated according to the external standard method, n-hexane, acetone, Tetrahydrofuran, dichloromethane, acetonitrile, toluene and xylene residues shall be in accordance with the provisions. Precisely weigh about 0.3g of 2-ethylhexanoic acid and add 33% hydrochloric acid solution 4. The Oml is made into a suspension solution, which shall be determined according to law (General rule 0873), and calculated as anhydrous and solvent-free substances, and shall not exceed 0.3%.
moisture
take this product, according to the moisture determination method (General 0832 first method 1), the moisture content should be 12.6% ~ 13.1%.
Heavy metals
This product l.Og, inspection according to law (General Principles 0821 second law), containing heavy metals shall not exceed 10 parts per million.
Last Update：2022-01-01 13:37:51
Faropenem sodium - Content determination
Authoritative Data Verified Data
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
silica gel bonded with octylsilane as filler; Phosphate buffer solution (4.8g of potassium dihydrogen phosphate, 5.4g of disodium hydrogen phosphate and 1.g of tetrabutylammonium bromide, dissolved in water and diluted to 1000ml, shake well)-Acetonitrile (85:15) as mobile phase; Detection wavelength was 305nm; Flow rate was 1.0ml per minute; Column temperature was 40°C. Take appropriate amount of faropenem reference substance and impurity I reference substance, add mobile phase to dissolve and dilute to make mixed solution containing about 0.25mg in each lml, take 20u1 injection human liquid chromatograph, record chromatogram, the degree of separation between the South Peak of faropei and the peak of impurity I should meet the requirements.
assay
take an appropriate amount of this product, accurately weigh, add mobile phase to dissolve and quantitatively dilute to prepare a solution containing about 0.25mg of faropenem per 1 ml as a test solution, A 20ul injection liquid chromatograph was used for precise measurement, and the chromatogram was recorded. An appropriate amount of faropenem reference substance was used for precise weighing, dissolution and quantitative dilution with mobile phase to prepare a solution containing about 0.25mg per 1 ml, which was determined by the same method. According to the external standard method, the content of C12H15N05S in the sample was calculated by the peak area.
Last Update：2022-01-01 13:37:52
Faropenem sodium - Category
Authoritative Data Verified Data
B-lactam antibiotics.
Last Update：2022-01-01 13:37:52
Faropenem sodium - Storage
Authoritative Data Verified Data
light shielding, sealing, and storage in the cool dark.
Last Update：2022-01-01 13:37:53
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View History
Faropenem sodium
2,4-二硝基苯羟胺
hidaco crystal violet
1M-3PP HCl (Methyl-3-phenylpropylamine Hydrochloride)
2-[(3-Methoxyphenyl)Methyl]-1,3-propanediol Acetate 3-Methanesulfonate
Ferrous sulphate heptahydrate
Formaldehyde, reaction products with diethanolamine
33100-26-4
1-(hydroxyimino)-1-naphthylethane
O-PHENOXYBENZOIC ACID
2,4-二硝基苯羟胺
hidaco crystal violet
1M-3PP HCl (Methyl-3-phenylpropylamine Hydrochloride)
2-[(3-Methoxyphenyl)Methyl]-1,3-propanediol Acetate 3-Methanesulfonate
Ferrous sulphate heptahydrate
Formaldehyde, reaction products with diethanolamine
33100-26-4
1-(hydroxyimino)-1-naphthylethane
O-PHENOXYBENZOIC ACID