Comply with the requirements stated under Tablets using the following method of analysis.

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. Apply separately to the plate 10 ul of each of the following solutions. For solution (1) shake a quantity of Ihe suppositones equivalent to 20 mg of Bisacodyl with 20 ml of light petroleum (boiling range 40° to GO*), filler, wash Ihe residue with light petroleum (boiling range 40° to 60"1 until free from fatty material and dissolve in 2 ml of acetone. For solution (2) dilute 3 volumes of solution (I) to 100 volumes with acetone. After removal of Ihe plate, allow it to dry in air and examine under ultra-violet light (254 nm.). Any secondary spot in the chromatogram obtained with solution [1) is not more intense than the spot in the chromalogram obtained with solution (2).Qther requirements Comply with Ihe requirements of tests stated under Sup posit ones. As say Weigh accurately a quantity of Ihe suppositories equivalent to 50 mg of Bisacodyl, add SO ml of anhydrous glacral acetic acid previously neutralised with 0.02M perchloric acid to 1-naphiholbenzem solution, warm gently until solution is complete and immediately carry out Method A for non-aqueous trtralion. Appendix 3 ,45, using 0.02M perchloric acid as the titrant and determining Ihe end-point potentiometrically Perform a blank determination and make any necessary correction Each ml of 0.02M perchloric acid is equivalent 1o 0 007228 g of C22H19N4-BISACGDYL TABLETS Usual strength 5 mg. STANDARDSBisacodyl Tablets contain not less than 95 ,0 per cent and not more than 105 0 per cent of the staled amount of bisacodyl. C22H19N04 The tablets are rendered g astro-resist ant by enteric coaing or by other means. Identification. A. Carry out the test for Related substances, applying lo Ihe plate 2 ul 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 lo that in the chromatogram obtained with solution (2) B: Extract a quantity of the powdered tablets equivalent to 50 mg of Bisacodyl with chloroform, fitter, evaporate the filtrateto dryness and dissolve the residue in 10 ml of a 1% w/v solution of sulphunc acid (solution A). To 2 ml of the solution add one drop of potassium mercuri-iodide solution; a white precipitate is produced. C; To 2 ml of solution A add sulphurrc acid;, a reddish-volet colour is produced D: Boil 2 ml of solution A with a few drops of nitric acid, a yellow colour is produced. Cool and add 5M sodium hydroxide. the colour becomes yellowish-blown. Related substances. Carry out the test method described under Bisacodyl Suppositories using as solution (1) a solution prepared in the following manner Shake a quantity of the powdered tablets equivalent to 20 mg of Bisacodyl with 2 ml of acetone for 10 minutes, centrifuge, and use the supernatant liquid. Any secondary spot in the chromatogram obtained with solution (1), other than any spot (due to tablet excipient), having a relative Rf of 1.3 compared with the principal spot, is not more intense than the spot in the chromatogram obtained with solution (2). Uniformity of content. Comply with the requirements stated under Tablets using the following method of analysis. Powder one tablet, shake with 70 ml of chloroform for 30 minutes and dilute with sufficient chloroform to produce 100 ml. Mix well, filter and discard the first few ml of the filtrate. Measure the absorbance of the filtrate at the maximum at about 264 nrn, Appendix 5.5. Calculate the content of C22H18N04 taking 148 as the value of A(1 %, 1 cm) at the maximum at about 264 nm. Disintegration Comply with the requirements stated under Tablets using a 1 5% w/v solution of sodium bicarbonate in place of mixed phosphate buffer pH 6.8. Other requirements Comply with the requirements of tests stated under Tablets Assay. Weigh and powder 20 tablets. Weigh accurately a quantity of the powder equivalent to 40 mg of Bisacodyl, shake with 70 ml of chloroform for 30 minutes, dilute to 100 0 ml with chloroform, mix, filter and dilute 10 ml of the filtrate to 100 ml with chloroform. Measure the absorbance of the resulting solution at the maximum at about 264 run. Appendix 5.5.