BRIEFING

 〈1155〉 Injectable Iron Colloidal Products—Characterization Methods. This new general chapter introduces essential characterization tests for injectable iron colloidal products alongside specific requirements not covered in other chapters.

 The formulation of iron colloidal injections, particularly for intravenous (IV) use, involves creating stable complexes of iron with carbohydrate ligands to ensure controlled release and minimize toxicity.

 This chapter specifically focuses on characterization methods required for iron colloidal injections. Because of their nonbiological complex drug (NBCD) nature, iron colloids cannot be fully defined by a single molecular structure. Therefore, comprehensive physicochemical characterization is essential, and this chapter presents those methods.

 The chapter details iron colloidal injections manufacturing, product quality and complications, general drug product quality tests, and characterization methods.

 (GCDF: V. Grandhi)

 Case ID—SUB-2270