Fusidic acid EP 测试方法.pdfVIP

Fusidic acid EUROPEAN PHARMACOPOEIA 8.0 Limits : – correction factors : for the calculation of content, multiply the peak areas of the following impurities by the corresponding correction factor: impurity C = 1.4; impurity D = 2.0; B. 2,4-dichloro-5-sulfamoylbenzoic acid, – impurity C : not more than twice the area of the principal peak in the chromatogram obtained with reference solution (b) (0.2 per cent); – impurity D : not more than 1.5 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.15 per cent); C. 2-amino-4-chloro-5-sulfamoylbenzoic acid, – unspecified impurities : for each impurity, not more than the area of the principal peak in the chromatogram obtained with reference solution (b) (0.10 per cent); – total : not more than 5 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.5 per cent); D. 2,4-bis[(furan-2-ylmethyl)amino]-5-sulfamoylbenzoic – disregard limit : 0.5 times the area of the principal peak in acid, the chromatogram obtained with reference solution (b) (0.05 per cent). Chlorides (2.4.4): maximum 200 ppm. To 0.5 g add a mixture of 0.2 mL of nitric acid R and 30 mL E. 2,4-dichlorobenzoic acid, of water R and shake for 5 min. Allow to stand for 15 min and filter. Sulfates (2.4.13): maximum 300 ppm. To 1.0 g add a mixture of 0.2 mL of acetic acid R and 30 mL of distilled water R and shake for 5 min. Allow to stand for 15 min and filter. F. 4-chloro-5-sulfamoyl-2-[[((2RS)-tetrahydrofuran-2- Heavy metals (2.4.8): maximum 20 ppm.