A method for separating and purifying the active hematinic species present in
iron-saccharidic
complexes including sodium ferric gluconate complex in sucrose, ferric hydroxide-sucrose
complex and ferric saccharate complex and others of similar form and function,
based on separation of the iron-saccharidic complex from one or more excipients
and, preferably, lyophilization. Separation of the iron-saccharidic complex permits
its analytical quantification; further concentration or purification as a new and
useful product; preparation of redesigned formulations for new and useful pharmaceuticals;
and/or lyophilization. The ability to separate the iron-saccharidic complex responsible
for hematinic function, including its lyophilized form, also provides a means for
preparing analytical material to verify and validate its pharmacological integrity,
patient safety and clinical performance, as well as analytical monitoring, standardization
and quality control inspection over hematinic manufacturing processes and establishment
of standards for use therewith.