is concordant with the reference spectrum of aspirin or with the spectrum obtained from aspirin RS .B ;Boil about 0 .5 g. with 10 ml of sodium

acid Category. Analgesic, antipyretic, anlirheumatic. antithrombotic. Dose As analgesic and antipyretic. 300 to BOO mg four to six times a day. as antirheumatc. 1 to 2 g. four to six times a day, up to 10 g daily, as antithrombofic, 75 mg daily Descnption Colourless crystals or white, crystalline powder odourless or almost odourless Solubilily Freely soluble in ethanol (95%); soluble in chloroform and in ether. slighty soluble in water Storage Store in tighrly-closed containers in a cool, dry place.STANDARDSAspirin contains not less than 99.5 per cent and not rnore than 100.5 per cent of CgH8 O4. calculated with reference to the dried substance. Identrfication Test A may be omitted f tests B, C and D are carried out Tests C and D may be omitted if tests A and B are carried out A: The infra-red absorption spectrum. Appendix 54. is concordant with the reference spectrum of aspirin or with the spectrum obtained from aspirin RS .B ;Boil about 0 .5 g. with 10 ml of sodium hydroxide solution for 3 minutes, cool and add 10 ml of dilute sulphuric acid; a white, crystalline precipitate is produced and the odour of acetic acid is perceptible Filter, dissolve the precipitate in about 2 ml of water and add ferric chloride lest solution; a deep violet colour is produced. C; To the filtrate obtained in test B add 3 ml of ethanol (95%) and 3 ml of sulphunc acid and warm, the odour of ethyl acetate is perceptible D: Melts at about 142°. Appendix 8.8 Clarity and colour of solution methanol A 1 % w/v solution in ethanol (95%) is clear. Appendix 6 1, and not more intensely coloured than reference solution BS8, Appendix 6 .2 Clarity of solution in alkali. A 5% w/v solution in warm 5% w/v solution of sodium carbonate is clear, Appendix 6. 1 Chlonde Boil 1. 75 g with 75 mf of water for 5 minutes, cool, add sufficient water to restore the original volume and filter 25 ml of the filtrate complies with the limit test for chlorides. Appendix 3 .10 [430 ppm) Sulphate 10 ml of the filtrate obtained in the test for Chloride complies with the limit test for sulphates, Appendix 3 .15 (600 ppm) Arsenic; Mix 5 g with 3 g of anhydrous sodium carbonate, add 10 ml of bromine solution and mix thoroughly Evaporate to dryness on a water-bath, gently ignite, and dissolve the cooled residue in 16 ml of brominated hydrochloric acid and 45 ml of water. .Remove the excess of bromine with 2 ml of stannous chloride AsT .The resulting solution complies with the limit test for arsenic. Appendix 3 9 [2 ppm) Heavy metals Not more than 10 ppm, determined by the following method Dissolved 2.g in 25ml of acetone, add l ml of water and 10ml of hydrogen sulphide solution, any colour produced is not more intense than that produced by mixing 25 ml of acetone, 1 0 ml of lead standard solution (20 pm Pb) and 10 ml of hydrogen sulphide solution. Readily carbonisable substances. Dissolve 0 50 g m 5 ml of sulphuric acid [containing 94 5% to 95.5% w/w of H2SO4, any colour produced is not more intense than that of reference solution BYS4, Appendix 6 2 Salicylic actd. Dissolve 2.5 g in sufficient ethanol (95%) to produce 25.0 ml (test solutions). To each of two matched Nessler cylinders add 48 ml of water and 1 ml of a freshly prepared acid ferric ammonium sulphate solution Into one cylinder pipette 1 D ml of a freshly prepared 0.010% w/v solution of salicylic acid and into the other pipette 1 0 ml of the test solution Mix the contents of the cylinders, after 30 seconds, the colour in the cylinder containing the test solution is not more intense than that in the cylinder containing the standard solution (0 ,1 %) Suiphated ash; Not more than 0 .1 %. Appendix 3.22 Loss on drying. Mot more than 0. 5%, determined on 1 g bydrying over phosphorus pentoxide at a pressure of 1 .5 to 2.5 kPa, Appendix 8. 6. Assay Weigh accurately about 1.5 g. dissolve in 15 rnl of ethanol (95%), add 50.0 ml of 0.5M sodium hydroxide, boil gentiy for 10 minutes, cool and titrate the excess of alkali with 0.5M hydrochloric acid using phenol red solution as indicator. Repeat the operation without the substance being examined. The difference between the btratians represents the amount of sodium hydroxide ,required. Each ml of 0 .5M sodium hydroxide is equivalent to 0. 04504 g ofc9h8o4 ASPiRiN TABLETS Acetylsalicyiic Acid Tablets Usual strengths; 75 mg; 150 mg, 300 mg; 6OO mg Storage; Store in tightly-closed containers in a cool, dry place STANDARDSAspirin Tablets contain not less than 95. 0 per cent and not more than 1 05.0 per cent of the stated amount of aspirin, C9h8o4 ldentrtication. A quantity of the powdered tablets equivalent to 0. 5 g of Aspirin complies with test B described under Aspinn. Salicylic acid; Shake a quantity of the powdered tablets equivalent to 0; 2 g of Aspirin with 4 ml of ethanol (95%), dilute to 100 .0.ml with water, filter immediately, transfer 50 ml of the filtrate to a Nessier cylinder, add 1 0 ml of freshly prepared acid feme ammonium sulphate solution, mix and allow to stand for 1 minute, the violet