METHOD FOR PRODUCING PURIFIED HEMATINIC IRON-SACCHARIDIC COMPLEX AND PRODUCT PRODUCED

摘要

A method for measuring at least one molecular characteristic of an iron-saccharidic complex present in a composition comprising one or more excipients, said complex comprising at least one active hematinic species (AHS), said method comprising: (A) using a first portion of said composition and substantially separating said AHS from said one or more excipients to obtain purified AHS; (B) determining the differential refractive index increment (dn/dc) of said purified AHS, (C) subjecting a second portion of said composition to liquid chromatographic analysis (LCA) having a refractive index (RI) detector and in-line eluate stream detection using laser light scattering (LLS); and (D) calculating said at least one molecular characteristic based on said LCA and said dn/dc value.