Patent ID: 8076149

Claim:
A method of producing an enoxaparin preparation, the method comprising the steps of: providing an isolated tetrasaccharide fraction of a size fractionated enoxaparin batch; evaluating the tetrasaccharide fraction using high performance liquid chromatography (HPLC) to determine the presence of at least one of the chains shown in the following 1st table: Peak # Assignment 1 ΔUH NS6S I 2S H NS6S 2 ΔUH NS6S I 2S H NS6S ΔU gal H NS6S I 2S Man NS6S 3 ΔU 2S H NS6S I 2S H NS (α) 4 ΔU 2S H NS6S I 2S H NS (β), ΔU 2S H NS6S I 2S Man NS (β) 5 ΔU 2S H NS6S I 2S Man NS (α), ΔU 2S H NS I 2S H NS6S (α) 6 ΔU 2S H NS I 2S H NS6S (β) 7 ΔU 2S H NS6S I 2S Man NS (1,6 anhydro) 8 ΔU 2S H NS6S I 2S H NS (1,6 anhydro) 9 ΔU 2S H NS6S G 2S H NS (α) 10 ΔU 2S H NS6S GH NS6S (α) 11 ΔU 2S H NS6S GMan NS6S (α,β) 12 ΔU 2S H NS6S I 2S H NS6S (α), ΔU 2S H NS6S I 2S Man NS6S (β) 13 ΔU 2S H NS6S I 2S H NS6S (β), ΔU 2S H NS6S I 2S Man NS6S (α) 14 ΔU 2S H NS6S G 2S H NS6S (α) 15 ΔU 2S H NS6S G 2S H NS6S (β) or to determine the presence of a peak in an amount identified in the following 2 nd table: Chain Sequencing by SAX- HPLC Range A Distribution Area % of Range B Range C by Area % HPLC peaks Area % Area % Peak 1 0.1 0.6 Present or Present or Detectable Detectable Peak 2 0.6 1.2 0.6 1.2 0.4 1.4 Peak 3 0.6 1.2 0.4 1.0 0.2 1.2 Peak 4 1.8 3.6 1.7 4.1 0.9 4.9 Peak 5 2.1 3.7 2.2 4.0 1.6 4.6 Peak 6 0.5 1.6 0.4 1.6 0.0 2.0 Peak 7 5.9 9.0 5.6 9.2 4.4 10.4 Peak 8 7.0 9.9 6.6 10.2 5.4 11.4 Peak 9 0.9 1.6 0.8 1.4 0.6 1.6 Peak 10 5.0 6.2 4.9 6.7 4.3 7.3 Peak 11 1.2 1.9 1.0 2.2 0.6 2.6 Peak 12 39.7 48.0 38.1 48.9 34.5 52.5 Peak 13 18.1 20.7 17.8 20.8 16.8 21.8 Peak 14 2.3 4.0 1.9 4.3 1.1 5.1 Peak 15 0.6 1.4 0.4 1.6 0.0 2.0 * Peak numbers referenced in this 2 nd Table correlate to the chains associated with said peaks in the 1 st Table and based upon the determination, further processing the enoxaparin batch by a method including one or more steps selected from the group consisting of classifying, selecting, accepting, discarding, releasing, withholding, processing into a drug product, shipping, moving to a different location, formulating, labeling, packaging, releasing into commerce, selling, and offering for sale the enoxaparin batch.