Browse: British Pharmacopoeia 2009 British Pharmacopoeia Volume III Formulated Preparations: Specific Monographs Aspirin Tablets Aspirin Tablets General Notices Acetylsalicylic Acid Tablets Action and use Salicylate; non-selective cyclo-oxygenase inhibitor; antipyretic; analgesic; anti-inflammatory. DEFINITION Aspirin Tablets contain Aspirin. The tablets comply with the requirements stated under Tablets and with the following requirements. Content of aspirin, C,H,O, 95.0 to 105.0% of the stated amount. IDENTIFICATION Boil 0.5 g of the powdered tablets for 2 to 3 minutes with 10 ml of 5M sodium hydroxide , cool and add an excess of 1M sulphuric acid ; a crystalline precipitate is produced. To a solution of the precipitate in water add iron( Ii) chloride solution Rt ; a deep violet colour is produced. TESTS Salicylic acid Shake a quantity of the powdered tablets containing 0.20 g of Aspirin with 4 ml of ethanol (96%) and dilute to 100 ml with water at a temperature not exceeding 10°. Filter immediately, transfer 50 ml of the filtrate to a Nessler cylinder, add 1 ml of freshly prepared ammonium iron( Ih) sulphate solution R1 , mix and allow to stand for 1 minute. Any violet colour produced is not more intense than that obtained by adding 1 ml of freshly prepared ammonium iron{ Ili } sulphate solution R1 to a mixture of 3 ml of a freshly prepared 0.10% wiv solution of salicylic acid , 2ml of ethanol (96%) and sufficient water to produce 50 ml contained in a second Nessler cylindet (3.0%). Dissolution Comply with the requirements for Monographs of the British Pharmacopoeia in the dissolution test for tablets and capsules , Appendix XII B1, using as the medium 500 ml of a pH 4.5 buffer prepared by mixing 29.9 g of sodium acetate and 16.6 ml of glacial acetic acid with sufficient water to produce 10 litres and rotating the basket at 50 revolutions per minute. Withdraw a sample of 20 ml of the medium and filter. Immediately measure the absorbance of the filtrate, Appendix | B, diluted with the dissolution medium if necessary, at 265 nm using dissolution medium in the reference cell. Measure the absorbance of a suitable solution of ©Crown Copyright 2006aspirin BPCRS in the dissolution medium and calculate the total content of aspirin, CsHgO,, in the medium using the declared content of CsH.O, in aspirin BPCRS ASSAY Weigh and powder 20 tablets. To a quantity of the powder containing 0.5 g of Aspirin add 30 ml of 0.5M sodium hydroxide VS , boil gently for 10 minutes and titrate the excess of alkali with 0.5M hydrochloric acid VS using phenol red solution as indicator. Repeat the operation without the substance being examined. The difference between the titrations represents the amount of sodium hydroxide required. Each ml of 0.5M sodium hydroxide VS is equivalent to 45.04 mg of CsH,O.. LABELLING The label states that the tablets contain Aspirin, unless this word appears in the name of the tablets. This requirement does not apply in countries where exclusive proprietary rights in the name Aspirin are claimed. ©Crown Copyright 2006