去羟肌苷BP2009质量标准.pdf

Browse: British Pharmacopoeia 2009 British Pharmacopoeia Volume I II Monographs: Medicinal and Pharmaceutical Substances Didanosine Didanosine General Notices (Ph Eur monograph 2200) C H N O 236.269655-05-6 10 12 4 3 Action and use Nucleoside reverse transcriptase inhibitor; antiviral (HIV). Ph Eur DEFINITION 9-(2,3-Dideoxy- - -glycero-pentofuranosyl)-1,9-dihydro-6H-purin-6-one (2 ,3 -dideoxyinosine) β D ′ ′ . Content 98.5 per cent to 101.0 per cent (anhydrous substance). CHARACTERS Appearance White or almost white, crystalline powder. Solubility Sparingly soluble in water, freely soluble in dimethyl sulfoxide, slightly soluble in methanol and in ethanol (96 per cent). IDENTIFICATION A. Infrared absorption spectrophotometry (2.2.24). Comparisondidanosine CRS. B. Specific optical rotation (2.2.7): - 24.2 to - 28.2 (anhydrous substance). ©Crown Copyright 2006 1 B. Specific optical rotation (2.2.7): - 24.2 to - 28.2 (anhydrous substance). Dissolve 0.100 g in water R and dilute to 10.0 ml with the same solvent. TESTS Related substances Liquid chromatography (2.2.29). Prepare the solutions immediately before use. Solvent mixtureMix 8 volumes of mobile phase B and 92 volumes of mobile phase A. Test solutionDissolve 25.0 mg of the substance to be examined in 50.0 ml of the solvent mixture. Reference solution (a)Dilute 1.0 ml of the test solution to 100.0 ml with the solvent mixture. Dilute 1.0 ml of this solution to 10.0 ml with the solvent mixture. Reference solution (b)Dissolve 5.0 mg of didanosine impurity A CRS in the solvent mixture and dilute to 100.0 ml with the solvent mixture. Dilute 1.0 ml to 20.0 ml with the solvent mixture. Reference solution (c)Dissolve 5 mg of didanosine for syste