Sunday, August 2, 2009

. STANDARDSBisacodyl Suppositories contain not less than 90.0 per cent and not more man 110.0 per cent of Ihe stated amount of bisacodyl, C22H19NO4 Id

place. STANDARDSBisacodyl Suppositories contain not less than 90.0 per cent and not more man 110.0 per cent of Ihe stated amount of bisacodyl, C22H19NO4 Identification. A Carry out the test for Related substances, applying to the plate 2ul of each solution and using as solution (2) a 1. 0% w/v solution of bisacodyl RS in acetone The principal spot in Ihe chromatogram obtained with solution (1) corresponds to that in the chromatogram obtained with solution (2). B. Dissolve a quantity of the suppositones equivalent To 0 15 g of Bisacodyl as completely as possible in 150 ml of light petroleum [boiling range 40" to 60°). filler, wash the residue with light petroleum (boiling range 40° to GO0) until free from fatty material and dry at about 100" Wash with a very small quantity of warm chloroform and dissolve the residue in 10 ml of a 1 %w/v solution of sulphuric acid (solution A). To 2 ml of Ihe solution add one drop of potassium mercuri-iodide solution, a while precipitate is produced. C To 2 ml of Ihe solution A add sulphuric acid, a reddish violet colour is produced D .Boil 2 ml of the solution A with a few drops of nitric acid, a yellow colour is produced Cool and add5M sodium hydroxide, the colour becomes yellowish brown Related substances Carry out the method for thin-layer chromatagraphy. Appendix 4 B, using silica gel GF254 as the coating substance and a mixture of equal volumes of xylene and 2-butanone as the mobrle phase.

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