盐酸莫西沙星EP.pdfVIP

Moxifloxacin hydrochloride EUROPEAN PHARMACOPOEIA 6.2 — impurities C, E : for each impurity, not more than the area of the principal peak in the chromatogram obtained with reference solution (a) (0.2 per cent); — any other impurity : for each impurity, not more than the area of the principal peak in the chromatogram obtained with reference solution (a) (0.2 per cent); — total : not more than 5 times the area of the principal peak in the chromatogram obtained with reference solution (a) C. 6,7,8,14-tetradehydro-4,5α-epoxy-6-methoxy-17- (1.0 per cent); methylmorphinan-3-ol (oripavine), — disregard limit : 0.25 times the area of the principal peak in the chromatogram obtained with reference solution (a) (0.05 per cent). The thresholds indicated under Related substances (Table 2034.-1) in the general monograph Substances for pharmaceutical use (2034) do not apply. Iron (2.4.9): maximum 5 ppm. Dissolve the residue from the test for sulphated ash in D. 7,8-didehydro-4,5α-epoxy-17-methylmorphinan- water R and dilute to 10.0 ml with the same solvent. 3,6α,10α-triol (10S-hydroxymorphine), Water (2.5.12): 10.4 per cent to 13.4 per cent, determined on 0.10 g. Sulphated ash (2.4.14): maximum 0.1 per cent, determined on 2.0 g. ASSAY Dissolve 0.500 g in 120 ml of anhydrous acetic acid R. Titrate with 0.1 M perchloric acid, determining the end-point potentiometrically (2.2.20). E. 7,8-didehydro-4,5α-epoxy-3-hydroxy-17-methylmorphinan- 6-one (morphinone), 1 ml of 0.1 M perchloric acid is equivalent to 66.88 mg