硫酸新霉素欧洲药典 EP 8.0.pdfVIP

Neomycin sulfate EUROPEAN PHARMACOPOEIA 8.0 System suitability : – resolution : minimum of 2.5 between the first peak (neohesperidin-dihydrochalcone) and the second peak (impurity F) in the chromatogram obtained with reference solution (d), – chromatogram obtained with reference solution (a) is similar to the chromatogram provided with neohesperidin-dihydrochalcone CRS. B. 7-[[2-O-(6-deoxy-α-L-mannopyranosyl)-β-D- Limits : glucopyranosyl]oxy]-5-hydroxy-2-(3-hydroxy-4- methoxyphenyl)-4H-1-benzopyran-4-one (neodiosmin), – impurity B : not more than the area of the principal peak in the chromatogram obtained with reference solution (b) (2 per cent), – impurity D : not more than twice the area of the principal peak in the chromatogram obtained with reference solution (c) (2 per cent), – any other impurity : not more than 0.5 times the area of the principal peak in the chromatogram obtained with reference solution (c) (0.5 per cent), C. (2RS)-7-[[2-O-(6-deoxy-α-L-mannopyranosyl)-β- – total of all impurities apart from impurity B : not more D-glucopyranosyl]oxy]-5-hydroxy-2-(3-hydroxy-4- than 2.5 times the area of the principal peak in the methoxyphenyl)-2,3-dihydro-4H-1-benzopyran-4-one chromatogram obtained with reference solution (c) (2.5 per (neohesperidin), cent), – disregard limit : 0.05 times the area of the principal peak in the chromatogram obtained with reference solution (c) (0.05 per cent). Heavy metals (2.4.8): maximum 10 ppm. 2.0 g complies with test D. Prepare the reference solution using 2 mL of lead standard solution (10 pp