阿昔洛韦BP2009质量标准.pdf

Browse: British Pharmacopoeia 2009 British Pharmacopoeia Volume I II Monographs: Medicinal and Pharmaceutical Substances Aciclovir Aciclovir General Notices (Ph Eur monograph 0968) C H N O 225.259277-89-3 8 11 5 3 Action and use Purine nucleoside analogue; antiviral (herpesviruses). Preparations Aciclovir Cream Aciclovir Eye Ointment Aciclovir Intravenous Infusion Aciclovir Oral Suspension Aciclovir Tablets Dispersible Aciclovir Tablets Ph Eur DEFINITION Aciclovir contains not less than 98.5 per cent and not more than the equivalent of 101.0 per cent of 2-amino-9-[(2-hydroxyethoxy)methyl]-1,9-dihydro-6H-purin-6-one, calculated with reference to the anhydrous substance. CHARACTERS A white or almost white, crystalline powder, slightly soluble in water, freely soluble in dimethyl sulphoxide, very slightly soluble in ethanol (96 per cent). It dissolves in dilute solutions of mineral acids and alkali hydroxides. IDENTIFICATION Examine by infrared absorption spectrophotometry (2.2.24), comparing with the spectrum obtained with aciclovir CRS. ©Crown Copyright 2006 1 obtained with aciclovir CRS. TESTS Appearance of solution Dissolve 0.25 g in 0.1 M sodium hydroxide and dilute to 25 ml with the same solvent. The solution is clear (2.2.1) and not more intensely coloured than reference solution Y7 (2.2.2, Method II). Related substances A. Examine by thin-layer chromatography (2.2.27), using silica gel GF254 R as the coating substance. Prepare the solutions immediately before use. Test solutionDissolve 0.1 g of the substance to be examined in dimethyl sulphoxide R and dilute to 10 ml with the same solvent. Reference solutionDissolve 5 mg of aciclovir impurity A CRS in dimethyl sulphoxide R and dilute to 10 ml with the same solvent. Dilute 1 ml of the solution to 10 ml with dimeth