Molecular Formula | C17H13N3Na2O6 |
Molar Mass | 401.28 |
Storage Condition | 2-8℃ |
This product is (E)-5-[[4-[(2-carboxyethyl) carbamoyl] phenyl] azo] Salicylic acid disodium salt dihydrate. The content of C17H13N3Na206 shall be 98.0% to 102.0% based on the calculation of water-free and solvent-free substances.
take this product (0.10g, add water 30ml to dissolve, according to the law to determine (General 0631),pH value should be 7.0~9.0.
take an appropriate amount of this product, accurately weigh it, add the mobile phase to dissolve and dilute to make a solution containing about 0.3mg per lml, as a test solution; Take lml for precision, set in a 100ml measuring flask, dilute to the scale with the mobile phase, and shake to serve as a control solution. In addition to the detection wavelength of 240nm, according to the chromatographic conditions under the content determination item, 20 u1 of the control solution and the test solution were accurately measured, and the human liquid chromatograph was injected respectively, the chromatogram was recorded to 4 times the retention time of the main component peak. If there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be greater than 0.5 times (0.5%) the area of the main peak of the control solution, and the sum of the areas of each impurity peak shall not be greater than the area of the main peak of the control solution (1.0%).
precision weighing this product l.O g, put it in a 50ml measuring flask, add water to dissolve and dilute to the scale, shake well, take 5ml accurately, place it in the top empty bottle, seal it, and use it as a test solution; precision weighing the right amount of anhydrous ethanol, water quantitative dilution made per lml containing 0.1 mg of the solution, 5ml of which was precisely weighed, was placed in a headspace bottle, and sealed 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; The initial temperature is 30°C, hold for 5 minutes, raise the temperature to 80°C at a rate of 2°C per minute, then raise the temperature to 200°C at a rate of 30°C per minute for 5 minutes; The detector temperature is 200°C, the inlet temperature was 180°C; The headspace bottle equilibration temperature was 80°C and the equilibration time was 30 minutes. 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, the residual amount of ethanol should comply with the provisions.
take this product, according to the moisture determination method (General 0832 first method), the moisture content should be 8.0% ~ 10.0%.
This product l.Og, inspection according to law (General Principles 0821 second law), containing heavy metals shall not exceed 20 parts per million.
measured by high performance liquid chromatography (General 0512).
silica gel bonded with a Eighteen alkyl silane as a filler; O.Olmol/L potassium dihydrogen phosphate solution (0.1 mol/L potassium hydroxide solution to adjust the pH value to 6.8)-methanol (60:40) as mobile phase; The detection wavelength was 361nm. The number of theoretical plates shall not be less than 2000 based on the balsalazide sodium peak.
take an appropriate amount of this product, accurately weigh it, add the mobile phase to dissolve and quantitatively dilute it to make a solution containing about 15ug per lml, which is used as the test solution, accurately take lOpl injection liquid chromatograph, record chromatogram; Another balsalazide sodium reference substance, the same method for determination. According to the external standard method to calculate the peak area, that is.
therapeutic agents for inflammatory bowel disease.
sealed storage.
use | anti-ulcerative colitis drugs. |