环孢素-英国药典bp2009.pdf

Browse: British Pharmacopoeia 2009 British Pharmacopoeia Volume I II Monographs: Medicinal and Pharmaceutical Substances Ciclosporin Ciclosporin General Notices (Ph Eur monograph 0994) C62 H111N11O12 120359865-13-3 Action and use Calcineurin inhibitor; immunosuppressant. Ph Eur DEFINITION Cyclo[[(2S,3R,4R,6E)-3-hydroxy-4-methyl-2-(methylamino)oct-6-enoyl]- -2-aminobutanoyl-N- L methylglycyl-N-methyl- -leucyl- -valyl-N-methyl- -leucyl- -alanyl- -alanyl-N-methyl- - L L L L D L leucyl-N-methyl- -leucyl-N-methyl- -valyl]. L L Substance produced by Beauveria nivea ( Tolypocladium inflatum Gams) or obtained by any other means. Content 98.5 per cent to 102.0 per cent (dried substance). CHARACTERS Appearance White or almost white powder. Solubility Practically insoluble in water, freely soluble in anhydrous ethanol and in methylene chloride. IDENTIFICATION A. Infrared absorption spectrophotometry (2.2.24). ©Crown Copyright 2006 1 Comparisonciclosporin CRS. 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 principal peak in the chromatogram obtained with reference solution (a). TESTS Appearance of solution The solution is clear (2.2.1) and not more intensely coloured than reference solution Y , BY 5 5 or R7 (2.2.2, Method II). Dissolve 1.5 g in anhydrous ethanol R and dilute to 15 ml with the same solvent. Specific optical rotation (2.2.7) - 185 to - 193 (dried substance). Disso