Sunday, August 2, 2009

Apply separately to the plate 10 ul of each of the following solutions.

. 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

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