Iron Proteinsuccinylate

Based on R&D experience in the field of polymer drugs, the API is successfully developed and has already been approved by NMPA China. The critical quality attributes are equivalent to that of original product, such as clarity, molecular weight (Mw) and molecular weight distribution, and assay of Ferrum (Fe). The elucidation of structure was studied and the structure was compared with that of the commercial reference product from the aspects of protein composition and structure, succinic acid acylation part, iron-carrying structure, casein species origin identification, molecular weight and molecular weight distribution,etc. It shows the consistency and the product can meet the Drug Consistency Evaluation.