CRYSTALLINE IDENTITY OF FERRIC MALTOL MANUFACTURED BY WBCIL: WHY POLYMORPH 'A' MUST BE THE REGULATORY STANDARD FOR THE PURE ACTIVE PHARMACEUTICAL INGREDIENT
*Dr. Poulami Gupta Banerjee, Dr. Atanuka Paul and Dr. Argha Chakraborty
Ferric Maltol is a non-salt-based oral iron replacement therapy gaining recognition for its superior tolerability and optimized absorption. The efficacy and regulatory standard of this active pharmaceutical ingredient (API) are intrinsically linked to its solid-state properties, specifically its polymorphic forms. This article utilizes previously published analytical data, primarily focused on the materials designated by the manufacturer West Bengal Chemical Industries Ltd., Kolkata, India (WBCIL) as Polymorph 'A' and Polymorph 'S'. Polymorph 'A', characterized by an intrinsic melting point of approximately 300.2∘C and distinctive X-ray diffraction (XRD) peaks at 15.58∘ and 22.56∘ (2-theta). Polymorph 'S' exhibits a lower melting point of 276.56∘C and unique diffraction peaks. We conclude that Polymorph 'A' must be formally maintained as the singular, scientifically rigorous regulatory standard for the pure API identity, thereby ensuring consistency in quality control and rooting all stability and bioavailability claims in its well-characterized core structure.
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