Heparinase I, for EP Method

Heparinase I (heparin lyase I) cleaves heparin and to a lesser extent heparan sulfate (ratio approx. 3:1). We provides heparinase I for determining 1,6-anhydro derivatives in heparin sodium. This enzyme has proven to meet the system suitability required by the European Pharmacopoeia method. System suitability required by the European Pharmacopoeia Method: – peak area ratio: maximum 1.15 for the peaks due to 1,6-anhydro ΔIS-IS and 1,6-anhydro ΔIS in the chromatogram obtained with reference solution (b); – maximum 0.02 for the peaks due to ΔIS and reduced ΔIS in the chromatogram obtained with reference solution (c); – resolution: minimum 1.5 between the peaks due to reduced ΔIA and 1,6-anhydro ΔIS in the chromatogram obtained with refer-ence solution (c); – the content of 1,6-anhydro derivatives in heparin sodium CRS is within 1.5 per cent of the assigned content. Applications: Heparinase I is used for determining 1,6-anhydro derivatives in heparin sodium.