Molecular Formula | C14H13N5O5S2 |
Molar Mass | 395.41 |
Density | 1.89±0.1 g/cm3(Predicted) |
Melting Point | >180°C dec. |
Water Solubility | Soluble in water |
Solubility | dilute HCl: slightly soluble |
Appearance | solid |
Color | Pale Yellow to Light Yellow |
Maximum wavelength(λmax) | ['295nm(DMSO)(lit.)'] |
Merck | 14,1920 |
pKa | 9.70(at 25℃) |
Storage Condition | Keep in dark place,Sealed in dry,2-8°C |
Refractive Index | 1.861 |
Physical and Chemical Properties | White to yellowish crystalline powder, odorless or slightly smelly, almost insoluble in ethanol, ether or water. Melting point 170 ℃ (decomposition). UV maximum absorption (Ph = 7 phosphate buffer):223,186ran(ε 17400,19700). pKa9.70, cefdinir sodium ((3efdinir Sodium):C14H12N5O5S2Na. Melting point 220 ℃ (decomposition). |
Use | This product is for scientific research only and shall not be used for other purposes. |
WGK Germany | 3 |
RTECS | XI0367250 |
HS Code | 2941906000 |
Toxicity | LD50 orl-rat: >5600 mg/kg IYKEDH 23,93,1992 |
white to yellowish crystalline powder, odorless or slightly odorless. Melting point 170 °c (decomposition). pK. 9.70. Semi-synthetic third-generation cephalosporins. White crystalline powder. Slightly soluble in phosphate buffer, dilute hydrochloric acid, almost insoluble in water, methanol, ethanol, acetone and other general organic solvents, no obvious melting point.
using 7-ACA as a raw material, after protecting the 7-position amino group and the 2-position carboxyl group, it reacts with triphenylphosphorus to obtain a phosphide, which reacts with formaldehyde under alkaline conditions to obtain a vinyl derivative at the 3-position. This was treated with hydrochloric acid to give the compound. This compound is reacted with 4-bromoacetyl bromide in ethyl acetate in the presence of N-methylsilyl acetamide to give an acylated product. The obtained acylated product was added to dichloromethane and acetic acid, and nitrosation was carried out with an aqueous solution of sodium nitrite, followed by the addition of urea to destroy excess sodium nitrite to obtain a hydroxylamine compound. The hydroxylamine compound is reacted with thiourea in N,N-methylacetamide to give a crude compound. The crude compound was reacted with trifluoroacetic acid in anisole and recrystallized to obtain cefdinir.
(6R,7R)-7-[(2-amino-4-thiazolyl)-(oxime) acetyl] amino]-3-vinyl-8-oxo-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylic acid. The content of cefdinir (C14H13N505S2) shall not be less than 94.0% calculated as anhydrous.
take this product, precision weighing, add the above 0.1 mol/L phosphate buffer solution was dissolved and quantitatively diluted to prepare a solution containing about 10 mg per 1 ml, which was measured according to law (General rule 0621), and the specific rotation was from one 58 ° to one 66 °.
take this product, precision weighing, add the above 0.1 mol/L phosphate buffer solution and quantitative dilution of about 10ug per 1 ml of solution, according to UV-visible spectrophotometry (General 0401), determination of absorbance at 287nm wavelength, the absorption coefficient is 570 to 610.
The content of cefdinir (C14 H & uml; Ns OS S2) shall not be less than 94.0% calculated as anhydrous. PH, pH value should be 2.5~4.5. Water content should not exceed 2.0%; Ignition residue, residue should not exceed 0.2%. Containing heavy metals should not exceed 0.001%.
developed by Japan Fujisawa Pharmaceutical Industry Co., Ltd., launched in October 19, 91. In December 1 99, cefdinir was approved by the US FDA for marketing in the US under the trade name Omnicef. Cefdinir is obtained by structural modification based on cefixime, which makes up for the weak effect of the original third generation cephalosporins on Gram-positive bacteria. It has excellent antibacterial effect on Gram-positive and gram-negative bacteria. For Transmissibility impetigo, erysipelas, subcutaneous abscess, mastitis, trauma and postoperative surface infection, pharyngitis, acute bronchitis, Pneumonia, tonsillitis, urethritis, intrauterine infection.
take a small amount of this product, according to the law inspection (General 0981), should comply with the provisions.
take about 0.2g of this product, add water 20ml, make a uniform suspension, according to the law (General 0631),pH value should be 2.5~4.5.
operation in the dark. Precision weighing this product about 37.5mg, put 25ml brown measuring bottle, add the above 0. After dissolving 4ml of lmol /L phosphate buffer solution, dilute to the scale with mobile phase A, shake well and use it as A test solution, dilute to the scale with mobile phase A, shake, as A control solution; Precision take the appropriate amount of control solution, quantitative dilution with mobile phase A to make A solution containing about 0.75ug per 1ml, as A sensitivity solution. According to the high performance liquid chromatography (General rule 0512) test, silica gel bonded with eighteen alkyl silane was used as the filler; Mobile phase A was 0.25% of 5.5 tetramethylammonium hydroxide solution (adjusted to pH with phosphoric acid), and 0.1 mol/L ethylenediamine tetraacetic acid disodium solution 0.4, mobile phase B 0.25% tetramethylammonium hydroxide solution (with phosphoric acid to adjust the pH value to 5.5)-acetonitrile-methanol (500:300:200), add 0 per 1000ml. 1 mol/L ethylenediamine tetraacetic acid disodium solution 0.4, according to Table 1 for linear gradient elution. The column temperature was 40°C and the detection wavelength was 2541101. Take cefdinir control about 37.5mg, put 25ml brown measuring flask, add 0. After dissolving 4ml of lmol /L phosphate buffer solution, dilute to the scale with mobile phase A, shake well, heat in A water bath for about 35 minutes, prepare a mixed solution containing about 1.5mg of cefdinir and its degradation impurities per 1mL (wherein the amounts of impurities I, J, K, L are about 2% each), take 20u1 injection liquid chromatograph, record chromatogram should be basically consistent with the system applicable solution typical chromatogram, cefdinir peak retention time is about 22 minutes, the separation degree of cefdinir peak and impurity J peak should be not less than 1.2, impurity I peak and impurity J peak, the separation degree between cefdinir peak and impurity K peak and impurity K peak and impurity L peak shall meet the requirements. The sensitivity solution 20u1 was injected into the human liquid chromatograph, and the chromatogram was recorded. The signal-to-noise ratio of the peak height of the principal component should be greater than 10. 20 u1 of the test solution and the control solution were respectively injected into the human liquid chromatograph, and the chromatograms were recorded. If there are impurity peaks in the chromatogram of the test solution, the area of the impurity peak shall be in accordance with the limit requirements in table 2 when compared with the area of the main peak of the control solution, the sum of each impurity peak area shall not be greater than 3.0 times (3.0%) 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.
take this product, add the mixed solution of formamide and methanol (2:1) to dissolve, according to the method of determination of moisture (General Principles 0832 first method 1), the water content shall not exceed 2.0%.
take l.Og of this product and check it according to law (General rule 0841). The residue left shall not exceed 0.2%.
measured by high performance liquid chromatography (General 0512).
silica gel bonded with octanoalkyl silane as filler; 0.25% tetramethylammonium hydroxide solution (adjusted to pH 5.5 with phosphoric acid)-acetonitrile-methanol (900:60:40 ) , add 0 per 1000ml. The mobile phase was ethylene diamine tetraacetic acid disodium solution (lmol/L, 0.4ml), and the detection wavelength was 254nm. Take about 20mg of cefdinir control, put it in a 100ml brown measuring flask, and add 0. After dissolving 2ml of lmol/L phosphate buffer solution, dilute to scale with mobile phase, shake well, heat in water bath for about 35 minutes, to obtain a mixed solution containing about 0.9 mg of cefdinir and its degradation impurities per 1 mL (wherein the amount of impurities at the retention time of 1.2 and of the relative main peak is about 2% respectively), 20u1 was injected into human liquid chromatograph, and the chromatogram was recorded. The retention time of cefdinir peak was about 8 minutes, and the retention time of E-isomer peak was about 3.5 times of cefdinir peak, the separation degree of cefdinir peak and its impurity peak at relative retention time 0.9 and 1.2 should be not less than 1.20.
take this product about 20mg, precision weighing, 100ml brown flask, add the above 0. After dissolving 2ml of lmol/L phosphate buffer solution, dilute to scale with mobile phase, shake well, and use 20u1 as sample solution to record chromatogram; an appropriate amount of cefdinir reference substance 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 cefdinir C14H13N505S2 should be 90.0% ~ 110.0% of the label children.
The content of this product is light yellow or yellow powder or granules.
take the contents under the difference of loading, mix evenly, weigh an appropriate amount (about 0.lg equivalent to cefdinir) accurately, put it in a 100ml brown measuring flask, and add 0. After dissolving 10ml of lmol/L phosphate buffer solution, dilute to the scale with mobile phase, shake well, filter, Take 5ml of filtrate accurately, put it in a 25ml brown measuring flask, dilute to the scale with mobile phase, as a swab solution. According to the method under the cefdinir determination, obtained.
with cefdinir.
O.lg
shade, seal, and store in a cool place.