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US 7,816,144 B1Granted
Evaluating mixtures of low molecular weight heparins by chain profiles or chain mapping
AssigneeMomenta Pharmaceuticals, Inc.
InventorsZachary Shriver, Daniela Beccati, Ishan Capila, Nur Sibel Gunay, Jennifer Ozug, Steve Wudyka
Life of this patent
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Abstract
Methods for analyzing mixtures of polysaccharides, for example heparin such as unfractionated heparin and enoxaparin are described. In some instances, the mixtures are analyzed using fast performance liquid chromatography (FPLC) and high liquid performance chromatography (HPLC), e.g., strong anion exchange HPLC.
Claims7
A method of analyzing an enoxaparin preparation, comprising:
- providing an isolated hexasaccharide fraction from a size fractioned enoxaparin preparation;
- analyzing the hexasaccharide fraction using strong anion exchange high performance liquid chromatography (SAX-HPLC) to determine if one or more chains shown in the following table is present:
- Identification
- Hexasaccharide
- A
- ΔU2SHNS6SI2SHNS6SGHNS6S
- B
- ΔU2SHNS6SI2SHNS6SI2S (60-65%)
- ΔU2SHNS6SI2SHNS6SGHNS6S (35-40%)
- C
- ΔU2SHNS6SI2SHNS6SI2SHNS(1,6) (56%)
- ΔU2SHNS6SI2SHNS6SI2SManNS(1,6) (44%)
- D
- ΔU2SHNS6SI2SHNS6SI2SHNS6S
- E
- ΔU2SHNS6SI2SHNS6SI2SManNS6S
- and
- if one or more of said chains is present, processing said preparation, wherein processing includes one or more of selecting, accepting, processing into drug product, shipping, formulating, labeling, packaging or selling said preparation,
- thus analyzing the enoxaparin preparation.
16 more elements
Dependencies are inferred from the claim text.