Methods for monitoring a ferro-saccharide complex product, purifying a composition, and producing a hematinically composed, ferro-saccharide complex, and reconstituted hematinic complex

摘要

"METHODS FOR MONITORING A FERRO-SACARIDIC COMPLEX PRODUCT, TO PURIFY A COMPOSITION, AND TO PRODUCE HEMATINIC COMPOSITION, AND RECONSTITUTED HEMATINIC COMPLEX." A method for separating and purifying the active hematinic species present in the iron-saccharide complexes comprising the ferric glyceronate complex in sucrose, the ferric hydroxide-sucrose complex and the ferric saccharate complex and others of similar shape and function based on separation of the ferro-saccharide complex of one or more excipients and preferably the lyophilization of the ferro-saccharide complex allows its analytical quantification; further concentration or purification as a novel and useful product; the preparation of redesigned formulations for new and useful pharmaceutical products and / or lyophilization. The ability to separate the iron-saccharide complex responsible for hematin 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 in hematinic manufacturing processes and setting standards for use with them.