欧洲药典 Heparins, low-molecular-mass.pdfVIP

EUROPEAN PHARMACOPOEIA 7.0 Heparins, low-molecular-mass ASSAY Results : the spectrum obtained is similar to the appropriate Carry out the assay of heparin (2.7.5). The estimated potency specific low-molecular-mass heparin reference standard. is not less than 90 per cent and not more than 111 per cent B. The ratio of anti-factor Xa activity to anti-factor IIa activity, of the stated potency. The confidence limits of the estimated determined as described under Assay, is not less than 1.5. potency (P = 0.95) are not less than 80 per cent and not more C. Size-exclusion chromatography (2.2.30). than 125 per cent of the stated potency. Test solution. Dissolve 20 mg of the substance to be STORAGE examined in 2 mL of the mobile phase. In an airtight container. If the substance is sterile, store in a Reference solution. Dissolve 20 mg of heparin sterile, airtight, tamper-proof container. low-molecular-mass for calibration CRS in 2 mL of the LABELLING mobile phase. The label states: Column : — the number of International Units per milligram; — size : l = 0.30 m, Ø = 7.5 mm; — the animal species of origin; — stationary phase : appropriate porous silica beads (5 μm) — where applicable, that the substance is suitable for use in the with a fr