Automated SEC of Low Molecular Mass Heparins According to Pharmaeuropa

Low molecular mass heparins are salts of sulphated glucosaminoglycans having a mass average molecular mass less than 8000. At least 60% of the total mass has a molar mass less than 8000.

Low molecular mass heparins are obtained by fractionation or depolymerization of natural origin heparin. Batch-to-batch consistency is ensured by demonstrating that the mass average molecular mass and the mass percentage within defined molar mass ranges lower than 8000 are not less than 75% and not higher than 125% of the mean value stated as type specification.

Size exclusion chromatography (SEC, also knows as gel permeation chromatography GPC) is a relative method that enables the measurement of the mass average molecular weight and the percentages within defined molar mass ranges with just one measurement. For calibrating the system a low-molar-mass Heparin for calibration (CRS) is available. This substance can be used to establish a heparin calibration curve that enables the measurement of the absolute molecular masses precisely and with high accuracy.

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