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The Analytical Scientist / App Notes / 2014 / Automated USP and EP GPC/SEC analysis of low molecular weight heparin (LMWH)

Automated USP and EP GPC/SEC analysis of low molecular weight heparin (LMWH)

03/21/2014

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Introduction

Natural heparin is a polysaccharide and consists of molecular chains of varying lengths. Low molecular weight heparin (LMWH) consists of short chains and is used as anticoagulant in diseases that feature thrombosis and for prophylaxis against it. Because LMWH has more predictable anticoagulant effect and pharmacokinetics as well as less side-effects, it is recommended over unfractionated heparin. Various methods of heparin depolymerization are used to manufacture LMWH.

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LMWHs are defined as heparin salts having an average molecular weight of less than 8000 Da and for which at least 60% of all chains have a molecular weight less than 8000 Da. GPC/SEC is the method of choice to measure the molecular weight (molar mass) and the molecular weight fractions above/below a molecular weight limit. Both, the Pharmaeuropa and the US Pharmacopeia, require GPC/SEC to characterize e.g. Enoxaparin Sodium or other low molar mass heparin. As recently again demonstrated, these methods allow to measure true molar masses with inexpensive standard lab equipment and lowest experimental effort.
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