Evaluating the activity of low-molecular-weight heparin in preparations and substances

The task of developing effective production of low-molecular-weight heparins (LMH), which are widely used in clinical practice, is timely. The quality assurance system of pharmaceutical preparations under WHO guidance stipulates, in particular, the application of specific and selective quality monitoring of the activity of heparin in preparations and substances. Using a test system based on purified reagents (thrombin, factor Xa, antithrombin III), a technique for the measurement of LMH according to the anti-Xa/anti-IIa chromogenic method recommended by the European Pharmacopoeia has been developed. The proposed technique has been evaluated with respect to the main analytical characteristics. The established accuracy, precision, linearity, and reproducibility allow the validated chromogenic method adapted for the proposed test system to be recommended for introduction into the quality control of LMH production.