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[交流] 【求助】求欧洲药典6.5的tenoxicam

求欧洲药典6.5的tenoxicam
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(Ph Eur monograph 1156)


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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


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A. pyridin-2-amine,


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B. methyl 4-hydroxy-2-methyl-2H-thieno[2,3-e]1,2-thiazine-3-carboxylate 1,1-dioxide.


  Ph Eur