|Synonyms||WARFARIN SODIUM CRYSTALLINE CLATHRATE|
2H-1-benzopyran-2-one, 4-hydroxy-3-(3-oxo-1-phenylbutyl)-, sodium salt (1:1)
|Use||Used as an anticoagulant|
|Hazard Symbols||T+ - Very toxic|
|Risk Codes||R61 - May cause harm to the unborn child|
R28 - Very Toxic if swallowed
|Safety Description||S53 - Avoid exposure - obtain special instructions before use.|
S36/37/39 - Wear suitable protective clothing, gloves and eye/face protection.
S45 - In case of accident or if you feel unwell, seek medical advice immediately (show the label whenever possible.)
|UN IDs||UN 1544|
This product is 3-(a-acetonylbenzyl)-4-hydroxycoumarin sodium salt. The content of C19H15Na04 shall be 98.0%-102.0% based on the calculation of water-free and isopropyl alcohol-free.
take 0.10g of this product, Add 10ml of water to dissolve, and measure according to law (General rule 0631). The pH value should be 7.2~8.3.
take 0.50g of this product, Add 10ml of water to dissolve, the solution should be clear; If it is turbid, compared with No. 1 turbidity standard solution (General rule 0902 first method), it should not be more concentrated.
take 0.20g of this product and add 0902 ml of acetone to dissolve, the solution should be clear and colorless; If it is turbid, it should not be more concentrated compared with No. 1 turbidity standard solution (General rule first method); if the color, according to UV-visible spectrophotometry, according to the law to check (General 0401), at the wavelength of 460nm absorbance measurement, not more than 0.03.
take this product, add 5% sodium hydroxide solution to make a solution containing 0.125g per lml, according to UV-visible spectrophotometry (General rule 0401), the absorbance was measured at a wavelength of 385nm within 15 minutes and should not exceed 0.30.
take this product, add the mobile phase to dissolve and dilute to make a solution containing about 1 mg per 1 ml, as a test solution; Take an appropriate amount of precision, A solution containing about 2UG in 1 ml was prepared as a control solution by quantitative dilution with mobile phase. According to the chromatographic conditions under the content determination item, 20 u1 of each of the test solution and the control solution are accurately measured and injected into the human liquid chromatograph respectively, and the chromatogram is recorded to 3 times of 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 (0.1%) of the area of the main peak of the control solution, the sum of each impurity peak area shall not be greater than 2.5 times (0.5%) of the main peak area of the control solution.
precision weigh isopropanol about 0.785g, put it in a 100ml measuring flask, dilute it to the scale with water, shake it well, take 5ml, and add internal standard solution (1% propanol solution) 5ml, mixed, as a reference solution. Take another two parts of this product, each about 0.5g, precision weighing, separate into two 10ml measuring bottles, add 5ml internal standard solution to one measuring bottle, add water to dissolve and dilute to the scale, as a test solution containing internal standard substance and no internal standard substance. Take the above solution, according to Gas chromatography (General 0521) test, with 10% white carrier coated with 1500 polyethylene glycol 101 as stationary phase, at the column temperature of 70 deg C, calculate the amount of isopropyl alcohol contained in the test article, should be 7.5% ~ 8.5% (g/g).
take this product, according to the determination of moisture (General 0832 first method 1), the water content shall not exceed 2.0%.
measured by high performance liquid chromatography (General 0512).
silica gel bonded with eighteen alkyl silane was used as a filler; Acetonitrile-water-glacial acetic acid (55:45:1) was used as a mobile phase; The detection wavelength was 282mn. Take warfarin sodium, benzylidene acetone and 4-hydroxycoumarin, add mobile phase to dissolve and dilute to make solutions containing about 50ug in each lml, take 20u1 injection human liquid chromatograph, record chromatogram, the theoretical plate number shall not be less than 2000 according to the calculation of warfarin sodium peak. The separation degree between 4-hydroxycoumarin peak and benzylidene acetone peak shall be greater than 10.0, and the separation degree between benzylidene acetone peak and warfarin sodium peak shall be greater than 5.0.
take this product, precision weighing, adding mobile phase to dissolve and quantitatively dilute to make a solution containing about 50ug per lml, as a test solution, and inject 20u1 into the liquid chromatograph with precision, the chromatogram was recorded. Another reference substance of warfarin sodium was determined by the same method. According to the external standard method to calculate the peak area, that is.
light shielding, sealed storage.
This product contains warfarin sodium (C19H15Na04) should be 93.0% to 107.0% of the label amount.
This product is sugar-coated tablet or film-coated tablet, White after removing the coating.
Take 20 tablets of this product, precise weighing, fine grinding, precise weighing appropriate amount (about 5mg equivalent to warfarin sodium), put it in a 100ml measuring flask, add appropriate amount of mobile phase, shake to dissolve warfarin sodium, dilute to the scale with mobile phase, shake, filter, take the continued filtrate as a test solution, take 20 u1 with precision, and measure according to the method under the content determination of warfarin sodium.
with warfarin sodium.
(1)2.5m g (2)5mg
light shielding, sealed storage.