Evaluation of commercially available low molecular mass heparin products: an internal market surveillance study
Ina Barucija1✉, Amar Elezovic1, Alija Uzunovic1, Sabina Beslagic1, Dzenita Softic1
- 1 Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina, Banja Luka-Sarajevo, Bosnia and Herzegovina
Received 7 October 2026 · Accepted 7 October 2026 · Published 7 October 2026 · Corrected 9 November 2026
DOI: https://doi.org/10.5281/zenodo.23219655
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Key messages
- Tous les échantillons testés respectent les spécifications pharmacopéiales pour l'activité anti-Xa.
- Aucune activité atypique n'a été observée parmi les produits évalués.
- La surveillance du marché est essentielle pour garantir la qualité des produits LMWH.
Abstract
Introduction
Low molecular mass heparins (LMWHs) are complex biological products with activity profiles dependent on source material and manufacturing. Differences exist within the same therapeutic class, and the 2007-2008 contamination crisis highlighted the need for robust analytical control. Post-marketing surveillance complements pre-authorization quality assessment by providing direct evidence of product quality available to patients.
Materials and methods
The study evaluated 22 commercially available LMWH products (Enoxaparin, Dalteparin, Nadroparin) using a chromogenic assay measuring antithrombin activity against factor Xa or IIa. Absorbance data were analyzed with CombiStats software applying a parallel-line model to estimate relative potency. Additional quality attributes assessed included biological activity, bacterial endotoxins, and sterility according to European Pharmacopoeia methods.
Results
All 14 tested samples complied with specifications for anti-factor Xa activity. Additional quality attributes showed full compliance: 14/14 for anti-Xa activity, 4/4 for bacterial endotoxins, and 4/4 for sterility with no microbial growth. Potency was confirmed for all tested products with no atypical activity profiles observed.
Conclusion
All 22 LMWH samples complied with applicable pharmacopoeial requirements for quality parameters evaluated. Market surveillance supports continued quality assurance of LMWH products.
Original poster
References
- European Pharmacopoeia Commission. 2022. European Pharmacopoeia, 11th Edition. Council of Europe, Strasbourg, France.
- Usdin, S., 2009. The Heparin Story. Int. J. Risk Saf. Med. 21, 93–103.
- Ye, H. et al., 2013. Characterisation of currently marketed heparin products: Key tests for LMWH quality assurance. J. Pharm. Biomed. Anal. 85, 99–107.
- CombiStats User Guide. EDQM, current version.
