Patent ID: 7790466

Claim:
A method of analyzing an enoxaparin preparation, comprising: providing an isolated tetrasaccharide fraction from a size fractioned enoxaparin preparation; analyzing the tetrasaccharide fraction using strong anion exchange high performance liquid chromatography (HPLC) to determine if one or more chains shown in the following table is present or is present in amount identified in the following table: Range A Range B Range C % Area % Area % Area Peak under HPLC under HPLC under HPLC # Tetrasaccharide curve curve curve 1 ΔUH NS6S I 2S H NS6S 0.1 0.6 Present or Present or Detectable Detectable 2 ΔUH NS6S I 2S H NS6S 0.6 1.2 0.6 1.2 0.4 1.4 ΔU gal H NS6S I 2S Man NS6S 3 ΔU 2S H NS6S I 2S H NS (α) 0.6 1.2 0.4 1.0 0.2 1.2 4 ΔU 2S H NS6S I 2S H NS (β), 1.8 3.6 1.7 4.1 0.9 4.9 ΔU 2S H NS6S I 2S Man NS (β) 5 ΔU 2S H NS6S I 2S Man NS 2.1 3.7 2.2 4.0 1.6 4.6 (α), ΔU 2S H NS I 2S H NS6S (α) 6 ΔU 2S H NS I 2S H NS6S 0.5 1.6 0.4 1.6 0.0 2.0 (β) 7 ΔU 2S H NS6S I 2S Man NS 5.9 9.0 5.6 9.2 4.4 10.4 (1,6 anhydro) 8 ΔU 2S H NS6S I 2S H NS 7.0 9.9 6.6 10.2 5.4 11.4 (1,6 anhydro) 9 ΔU 2S H NS6S G 2S H NS (α) 0.9 1.6 0.8 1.4 0.6 1.6 10 ΔU 2S H NS6S GH NS6S (α) 5.0 6.2 4.9 6.7 4.3 7.3 11 ΔU 2S H NS6S GMan NS6S 1.2 1.9 1.0 2.2 0.6 2.6 (α, β) 12 ΔU 2S H NS6S I 2S H NS6S 39.7 48.0 38.1 48.9 34.5 52.5 (α), ΔU 2S H NS6S I 2S Man NS6S (β) 13 ΔU 2S H NS6S I 2S H NS6S 18.1 20.7 17.8 20.8 16.8 21.8 (β), ΔU 2S H NS6S I 2S Man NS6S (α) 14 ΔU 2S H NS6S G 2S H NS6S 2.3 4.0 1.9 4.3 1.1 5.1 (α) 15 ΔU 2S H NS6S G 2S H NS6S 0.6 1.4 0.4 1.6 0.0 2.0 (β) and if one or more of said chains is present or is present in an amount identified in the table, 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.