shake a quantity of the powdered tablets equivalent to 50 mg of Astemizofe with 10 ml of a mixture of equal vofumes

dichloromelhane and methanol for 15 minutes and filler Sofution (2) contains 0.5% w/v of astemizole RS in a mixture of equal volumes of dichloromelhane and methanot After removal of the plate, allow it to dry in air and examine under ultra-violet light (25d nm). Any secondary spot in the chromalogram obtained with solution (1) 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 Moisten one tablet with 1 ml of water, add 25 ml of 2-propanot. warm on a water-bath for 15 minutes, cool, dilute to 500 ml with 2-propanoth mix, centrifuge and carry out the procedure described under Assay on the supernatant liquid beginning at the words "Measure the absorbance ."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 about O.S g of Aslemizo]e transfer lo a 10Q-m1 volumetric flask, add 10 ml of water and about 50 ml of2-propanot Warm on a water-bath for-15 minutes, cool and dilute to volume with 2-propanot, mix and filter (Whatman 41 filter paper is suitable). Discard the first 10 ml of the filtrate and dilute 2.0 ml ofthe filtrate to 50 0 ml with 2-propanot Measure the absorbance of the resulting solution at the maximum al about 286 nm. Appendix 5 5 Calculate the content of C28 H31FN4 O from the absorbance obtained by repealing the operation using astemizole RS instead of the substance being examined and from the declared contenl of C28 H31 FN4 O in astermizole RS .ATENOLOLAtenelol is (RS)-4-(2-hydroxy-3-isopropylarninopropoxyjphenylacetamide Category Beta-adrenoceptor antagonist Dose 50 to 100 mg. daily, in 1 or 2 doses Description White or almost white powder Solubility Soluble in ethanot, sparingly soluble in water; slightly soluble in diehioromethane, practically insoluble in ether STANDAROSAtenotol contains not less than 99.0 per cent and not more Ehan 101 0 per cent of C14 H22 N2 O3. , calculated with reference to the dned substance. Identification Test A may be omitted if tests B, C and D are carried out Tests B and C may be omitted if lesls A and D are carried out A. The infra-red absorption spectrumh Appendix 5.4, is concordant with the reference spectrum of alenotol or with the spectrum obtained from atenotol RS.B The light absorption in the range 230 to 360