植物甾醇-BP2009.pdfVIP

Browse: British Pharmacopoeia 2009 British Pharmacopoeia Volume I II Monographs: Medicinal and Pharmaceutical Substances Phytosterol Phytosterol General Notices (Ph Eur monograph 1911) Ph Eur DEFINITION Natural mixture of sterols obtained from plants of the genera Hypoxis, Pinus and Picea. Content Minimum 70.0 per cent of β-sitosterol (dried substance). CHARACTERS Appearance White or almost white powder. Solubility Practically insoluble in water, soluble in tetrahydrofuran, sparingly soluble in ethyl acetate. IDENTIFICATION A. Mix 1 ml of acetic anhydride R with 0.5 ml of solution S (see Tests). After the addition of 0.1 ml of sulphuric acid R a red colour is produced, which changes rapidly to violet, then to blue and finally to green. B. Examine the chromatograms obtained in the assay. ResultsThe principal peak in the chromatogram obtained with the test solution is similar in retention time to the peak in the chromatogram obtained with reference solution (b). TESTS Solution S Dissolve 1.0 g in tetrahydrofuran R and dilute to 20 ml with the same solvent. Appearance of solution Solution S is clear (2.2.1) and not more intensely coloured than reference solution Y (2.2.2, 6 Method II). Acidity or alkalinity Shake 0.20 g with a mixture of 4.0 ml of ethyl acetate R and 10.0 ml of carbon dioxide-free water R for 3 min. Allow the layers to separate. To the aqueous layer add 0.1 ml of bromothymol blue solution R1. If the solution is yellow, not more than 0.5 ml of 0.01 M sodium ©Crown Copyright 2006 1 bromothymol blue solution R1. If the solution is yellow, not more than 0.5 ml of 0.01 M sodium hydroxide is required to change the colour to blue. If the solution is blue, not more than 0.5 ml of 0