. ASTEMIZOLE TABLETS Usual strength 10 mg Storage Store in well-closed, light-resist ant containers.

chromatogram obtained with solution (1) is not more intense than the spot in the chromalogram obtained with solution (2) Sulphated ash Not more than 0.1 %, Appendix 3 22.Loss on drying: Not more than 05%. determined on 1 g by drying in an oven at 105", Appendix 8 G Assay. Weigh accurately about O.S g and dissolve in 50 ml of a mixture of 7 volumes of 2-butanot and 1 volume of anhydrous glacial acetic acid Carry out Method B for non-aqueous Titration, Appendix 3 45H using 1 naptholbenzem as indicator. Perform a blank determination and make any necessary correction Each ml of 0.1M perchloric acid is equivalent to 0.02293 g of C28 H31 FN4 O. ASTEMIZOLE TABLETS Usual strength 10 mg Storage Store in well-closed, light-resist ant containers. STANDARDSAstemizole Tablets contain not less than 900 per cent and not more than 110.0 per cent of the stated amount of aslemizole. C28 H31 FN4 O. Identification A: Shake a quantity of the powdered tablets equivalent to 20 mg of Astemizole with 25 ml of chloroform for 10 minutes, filter and evaporate to dryness. The infra-red absorption spectrum of the residue. Appendix 5.J. is concordant with the reference spectrum of astemizofe or with the spectrum obtained from astemizofe RS.B The light absorption in the range 230 to 36D nm ofthe sofution obtained in the Assay exhibits maxima at about 249 nm and 206 run, Appendix 5.5.C: Carry out the method for thin-layer chrornatography. Appendix 4 6, using silica gel GF254 as the coating substance and a mixture of SJ vofumes of tofuene, 3D vofumes of dioxan, 10 vofumes of methanot and 1 vofume of strong ammonia sofution as the mobile phase Apply separately to the plate 10 ul of each of the foflowing sofutions For sofution