Deferasirox

General Information

Deferasirox Impurities and Deferasirox

Daicel Pharma synthesizes Deferasirox impurities of exceptional quality, such as 2-(5-chloro-2-hydroxyphenyl)-4H-benzo[e][1,3]oxazin-4-one, 6-chloro-2-(2-hydroxyphenyl)-4H-benzo[e][1,3]oxazin-4-one, and Deferasirox Dimethoxy Impurity. These impurities are crucial to assess the purity, reliability, and safety of an active pharmaceutical ingredient, Deferasirox. Besides, Daicel Pharma provides custom synthesis of Deferasirox impurities to meet clients’ demands for delivery worldwide.

Deferasirox [CAS: 201530-41-8], a synthetic achiral tridentate triazole derived from salicylic acid, is an iron chelating agent. Deferasirox treats chronic iron overload caused by blood transfusion or non-transfusion-dependent thalassemia.

Deferasirox: Use and Commercial Availability  

Deferoxamine is available under brand names like Exjade, Jadenu, and Jadenu Sprinkle for treating acute and chronic iron overload. It also treats aluminum toxicity in chronic kidney disease patients. Deferoxamine also treats acute iron ingestion and aluminum toxicity.

Deferasirox Structure and Mechanism of Action

The chemical name of Deferasirox is 4-[3,5-Bis(2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]benzoic acid. Its chemical formula is C₂₁H₁₅N₃O_4, and its molecular weight is approximately 373.4 g/mol.

Deferasirox binds to iron in a 2:1 ratio and removes iron from myocardial cells.

Deferasirox Impurities and Synthesis

Impurities in Deferasirox can originate from degradation of the active pharmaceutical ingredient, interaction with excipients, or contaminants in raw materials. They may impact the drug quality, safety, and efficacy. Analytical techniques such as chromatography and spectroscopy help analyze and characterize Deferasirox impurities. Their control measures involve establishing impurity level limits, following good manufacturing practices, and regular testing during the manufacturing process¹. Stringent quality control and monitoring ensure that Deferasirox batches meet regulatory standards and maintain high levels of purity, ensuring the effectiveness and safety of the medication.

Daicel Pharma offers a Certificate of Analysis (CoA) for Deferasirox impurity standards, such as 2-(5-chloro-2-hydroxyphenyl)-4H-benzo[e][1,3]oxazin-4-one, 6-chloro-2-(2-hydroxyphenyl)-4H-benzo[e][1,3]oxazin-4-one, and Deferasirox Dimethoxy Impurity, generated from an analytical facility compliant with cGMP standards. The CoA includes a comprehensive characterization report comprising data from techniques like 1H NMR, 13C NMR, IR, MASS, and HPLC purity². Furthermore, on request, we give additional data like 13C-DEPT and CHN. Daicel Pharma can synthesize unknown Deferasirox impurities or degradation products and labeled compounds to assess the effectiveness of generic Deferasirox. We also offer Deferasirox-D4, a deuterium-labeled Deferasirox standard useful in bio-analytical research, such as BA/BE studies. A complete characterization report accompanies every delivery.