Abstract: A method for separating and purifying the active hematinic species (AHS) present in iron-saccharidic compositions, including AHS such as sodium ferric gluconate complex, ferric hydroxide-sucrose complex and ferric saccharate complex and others of similar form and function. The method separates the AHS from one or more excipients and, preferably, lyophilizes the separated AHS. Separation of the AHS permits its analytical quantification, further concentration, purification and/or lyophilization as well as preparation of new and useful products and pharmaceutical compositions, including those useful for the treatment of humans and animals.

Abstract: A process for preparing parenteral iron-saccharidic complexes, and the complexes produced, comprising: (1) providing an aqueous solution or dispersion including (i) Fe(III) and (OH)? ions and (ii) at least one saccharide, to form a reaction mixture, where the molar ratio of (i): (ii) is about 30:1 to about 1:30; and the mixture temperature and pH are at or above the complex assembly point (CAP); and (2) maintaining temperature and pH at or above the CAP for a time sufficient to form an iron-saccharidic complex having a molecular weight of about 25,000 Daltons or more. Control of the temperature and pH efficiently produces a high molecular weight complex. The complex can be separated by precipitation, dialysis and/or column fractionation and, if desired, dried, e.g., lyophilized or spray dried. The process can controllably synthesize complexes of varying molecular weight and/or chemical composition, particularly sodium ferric gluconate and ferric hydroxide-sucrose.