CLOSANTELSODIUMDIHYDRATE.PDF

Closantel sodium dihydrate for veterinary use EUROPEAN PHARMACOPOEIA 6.0 — stationary phase: propylsilyl silica gel for chromatography R (5 μm); — temperature:40°C. Mobile phase: — mobile phase A: dissolve 4 g of potassium dihydrogen phosphate R in 1000 ml of water for chromatography R, B. 1-acetyl-2-[(2,6-dichlorophenyl)amino]-4,5-dihydro-1H- and adjust to pH 4.0 with phosphoric acid R; imidazole, — mobile phase B:mobilephaseA,acetonitrile R1 (25:75 V/V); Time Mobile phase A Mobile phase B (min) (per cent V/V) (per cent V/V) 09010 0-15 90 → 30 10 → 70 C. 2,6-dichloroaniline. 15 - 15.1 30 → 90 70 → 10 15.1 - 20 90 10 Flow rate:1.5ml/min. 01/2008:1716 Detection: spectrophotometer at 210 nm. Injection:5μl. CLOSANTEL SODIUM DIHYDRATE System suitability: reference solution (b): FOR VETERINARY USE — resolution : minimum 5 between the peaks due to clonidine and impurity B. Closantelum natricum dihydricum Limits: ad usum veterinarium — unspecified impurities: for each impurity, not more than the area of the principal peak in the chromatogram obtained with reference solution (a) (0.10 per cent); — total: not more than twice the area of the principal peak in the chromatogram obtained with reference solution (a) (0.2 per cent); — disregard limit: 0.5 times the area of the principal peak in the chromatogram obtained with reference solution (a) (0.05 per cent). C22H13Cl2I2N2NaO2,2H2O Mr 721 Loss on drying (2.2.32): maximum 0.5 per cent, determined [61438-64-0] on1.000gbydryinginanovenat105°C. Sulphated ash (2.4.14): maximum 0.1