Heparinase II, for EP 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.