POLYSACCHARIDE COMPOSITIONS AND RELATED METHODS

摘要

The disclosure provides LMWH preparations and methods of analyzing LMWH preparations having at least one chain having a glycol split uronic acid residue (UG) in the preparation for structural signatures, and methods of producing such preparations based upon the analysis.

主权项

1. A pharmaceutical composition comprising a LMWH preparation wherein the LMWH preparation has the following characteristics:
(a) a weight average chain molecular weight between 3,500 and 8,000 Da; (b) anti-Xa activity of less than 20 IU/mg and anti-IIa activity of 20 IU/mg or less; (c) greater than 5% and less than 50% glycol split uronic acid residue (UG) in the preparation, and wherein formic acid is detectable in the composition but at less than 2%, 1%, 0.5%, 0.3%, 0.2%, 0.1%, or 0.05% as determined by 1D-NMRand/or C2H6O3 is detectable in the composition but at less than 2%, 1%, 0.5%, 0.3%, 0.2%, 0.1%, or 0.05% as determined by 2D-NMR.