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US 8,273,580 B2Granted
Method of measuring the concentration of a glycosaminoglycan anticoagulant
AssigneeActive BioMaterials, LLC
InventorsRalph Yamamoto, Yumi Kim
Life of this patent
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Abstract
The invention provides an accurate, economical, automatable, high throughput method for the determination of the concentration of glycosaminoglycan anticoagulants, including low molecular weight heparin (LMWH) anticoagulants, in aqueous solutions. A method for cleaning a unit of manufacturing equipment used in the preparation of a LMWH to obtain an acceptable residual concentration of LMWH is further provided.
Claims10
A method of cleaning a unit of manufacturing equipment used in the preparation of heparin to obtain an acceptable residual concentration of heparin comprising:
- (a) subjecting the unit of manufacturing equipment to a cleaning protocol;
- (b) obtaining the absorbance of a sample obtained from the manufacturing equipment comprising:
- (i) collecting a sample from the manufacturing equipment;
- (ii) reacting the sample with 1,9-dimethyl-methylene blue;
- and
- (iii) determining the absorbance of the sample reacted with 1,9 dimethyl methylene blue;
- (c) determining the concentration of heparin in the sample obtained from the manufacturing equipment by comparing its absorbance with the absorbances of a plurality of samples of control heparin in aqueous solutions of known concentrations;
- and
- (d) optionally repeating steps (a)-(c) until the concentration of heparin in the sample obtained from the manufacturing equipment is less than an acceptable residual concentration of heparin.
6 more elements
Dependencies are inferred from the claim text.