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windli木虫 (职业作家)
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【求助】求欧洲药典6.5的tenoxicam
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求欧洲药典6.5的tenoxicam 哪位弟兄能帮帮忙 |
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ienjoysun
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小木虫(金币+0.5):给个红包，谢谢回帖交流
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(Ph Eur monograph 1156) [bitmap] C13H11N3O4S2 337.4 59804-37-4 Action and use Anti-inflammatory; analgesic. Preparations Tenoxicam Injection Tenoxicam Tablets Ph Eur DEFINITION Tenoxicam contains not less than 99.0 per cent and not more than the equivalent of 101.0 per cent of 4-hydroxy-2-methyl-N-(pyridin-2-yl)-2H-thieno[2,3-e]1,2-thiazine-3-carboxamide 1,1-dioxide, calculated with reference to the anhydrous substance. CHARACTERS A yellow, crystalline powder, practically insoluble in water, sparingly soluble in methylene chloride, very slightly soluble in ethanol. It dissolves in solutions of acids and alkalis. It shows polymorphism. IDENTIFICATION Examine by infrared absorption spectrophotometry (2.2.24), comparing with the spectrum obtained with tenoxicam CRS. If the spectra obtained in the solid state show differences, dissolve the substance to be examined and the reference substance separately in the minimum quantity of methylene chloride R, evaporate to dryness on a water-bath and record new spectra using the residues. TESTS Appearance of solution Dissolve 0.10 g in 20 ml of methylene chloride R. The solution is clear (2.2.1). Related substances Examine by thin-layer chromatography (2.2.27), using silica gel GF254 R as the coating substance. Test solution Dissolve 0.4 g in a mixture of 4 volumes of concentrated ammonia R and 96 volumes of methanol R and dilute to 5 ml with the same mixture of solvents. Reference solution (a) Dilute 1 ml of the test solution to 20 ml with a mixture of 4 volumes of concentrated ammonia R and 96 volumes of methanol R. Dilute 1 ml of the solution to 20 ml with the same mixture of solvents. Reference solution (b) Dissolve 20 mg of tenoxicam CRS and 20 mg of salicylic acid CRS in a mixture of 4 volumes of concentrated ammonia R and 96 volumes of methanol R and dilute to 5 ml with the same mixture of solvents. Reference solution (c) Dissolve 20 mg of pyridin-2-amine R in a mixture of 4 volumes of concentrated ammonia R and 96 volumes of methanol R and dilute to 5 ml with the same mixture of solvents. Dilute 2 ml of the solution to 50 ml with the same mixture of solvents. Apply separately to the plate 10 µl of each solution. Develop over a path of 15 cm with a mixture of 5 volumes of anhydrous formic acid R, 5 volumes of methanol R, 20 volumes of acetone R and 70 volumes of methylene chloride R. Allow the plate to dry in air. Examine in ultraviolet light at 254 nm. Any spot corresponding to pyridin-2-amine in the chromatogram obtained with the test solution is not more intense than the spot in the chromatogram obtained with reference solution (c) (0.2 per cent). Any spot in the chromatogram obtained with the test solution apart from the principal spot and any spot corresponding to pyridin-2-amine, is not more intense than the spot in the chromatogram obtained with reference solution (a) (0.25 per cent). The test is not valid unless the chromatogram obtained with reference solution (b) shows two clearly separated spots. Heavy metals (2.4.8) 0.5 g complies with limit test C for heavy metals (20 ppm). Prepare the standard using 5 ml of lead standard solution (2 ppm Pb) R. Water (2.5.12) Not more than 0.5 per cent, determined on 1.000 g by the semi-micro determination of water. Sulphated ash (2.4.14) Not more than 0.1 per cent, determined on 1.0 g. ASSAY Dissolve 0.250 g in 5 ml of anhydrous formic acid R. Add 70 ml of anhydrous acetic acid R. Titrate with 0.1 M perchloric acid, determining the end-point potentiometrically (2.2.20). 1 ml of 0.1 M perchloric acid is equivalent to 33.74 mg of C13H11N3O4S2. STORAGE Store protected from light. IMPURITIES [bitmap] A. pyridin-2-amine, [bitmap] B. methyl 4-hydroxy-2-methyl-2H-thieno[2,3-e]1,2-thiazine-3-carboxylate 1,1-dioxide. Ph Eur |
2楼2009-09-09 09:15:23
windli
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3楼2009-09-09 09:22:04
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4楼2009-09-10 08:40:46
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