Sunday, August 2, 2009

: Store in well-dosed, light-resist ant containers. STANDARDSBusulphan Tablets contain not less than 90 0 per cent and not more than 115.0 per cent of

with 50 ml of water Boil under a reflux condenser for 30 minutes and, if necessary, restore the initial volume with water Allow to cool and titrate with 0.1M sodium hydroxide, using 0.3 ml of dilute phenolphthalein solution as indicator, until a pink colour is produced Each ml of 0.1M sodium hydroxide is equivalent to 0.01232 g of C4H14O6S2 BUSULPHAN TABLETS Usual strength 2 mg Storage: Store in well-dosed, light-resist ant containers. STANDARDSBusulphan Tablets contain not less than 90 0 per cent and not more than 115.0 per cent of the stated amount of busulphan. C6H14O6S2 The tablets are coated Identification: A Warm a quantity of the powdered tablets equivalent to 10 mg of Busulphan with 10 ml of acetone, filter and evaporate the filtrate to dryness. Dry the residue at 60° at a pressure not exceeding 0.7 kPa for 1 hour The infra-red absorption spectrum of the residue, Appendix 5. 4. is concordant with the reference spectrum of busulphan or with the spectrum obtained from busulphan RS.B: In the Assay, the principal peak in the chromatogram obtained with solution (1) has the same retention time as that of the peak in the chromatogram obtained with solution (2) Disintegration Maximum time, 15 minutes, Appendix 7.1. Uniformity of content. Comply with the requirements stated under Tablets using the following method of analysis.

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