Patent ID: 8252597

Claim:
A method of processing an enoxaparin preparation, the method comprising the steps of: providing an enoxaparin preparation; determining by size exclusion chromatography the distribution of one or more size fractions in said enoxaparin preparation, and processing into drug product, shipping, formulating labeling or packaging said preparation when the determined distribution of the one or more size fractions corresponds to an amount listed for the one or more size fractions in the following first table and second table: FPLC Distribution of peaks Range A Range B Range C by Height % Height % Height % Height % Tetra- 14.8 17.8 14.1 18.8 12.5 20.4 Hexa- 21.2 23.9 20.8 23.9 19.7 24.9 Octa- 21.6 22.7 21.5 22.8 21.1 23.3 Deca- 19.8 21.2 19.7 21.5 19.1 22.0 Dodeca- 17.6 19.3 17.3 19.6 16.5 20.3 FPLC Distribution of peaks by Range A Range B Range C % Area Under % Area Under % Area Under % Area Under Curve Curve Curve Curve Tetra- 9.8 12.3 9.1 12.5 8.0 13.7 Hexa- 18.8 20.4 18.4 20.6 17.6 21.3 Octa- 16.8 17.4 16.6 17.5 16.3 17.9 Deca- 13.0 14.1 12.9 14.4 12.4 14.9 Dodeca- 34.0 38.8 33.4 39.9 31.3 42.0 and higher size chains.