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 C21H15N3O4, 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.
- Lattmann, Rene; Acklin, Pierre, Substituted 3,5-Diphenyl-1,2,4-Triazoles And Their Use As Pharmaceutical Metal Chelators, Novartis A-G., Switzerland, EP914118B1, October 23, 2002
- Kaja, Ravi Kiran; Surendranath, K. V.; Radhakrishnanand, P.; Satish, J.; Satyanarayana, P. V. V., A stability indicating LC method for deferasirox in bulk drugs and pharmaceutical dosage forms, Chromatographia, Volume: 72, Issue: 5/6, Pages: 441-446, 2010
Frequently Asked Questions
The control measures for Deferasirox impurities are optimizing reaction conditions, selecting high-quality starting materials, implementing effective purification techniques, and rigorous quality control testing at various stages of the manufacturing process.
Impurities in Deferasirox can originate from starting materials, intermediates, reagents, solvents, or degradation of the active ingredient during storage or manufacturing processes.
Impurities in Deferasirox can contribute to its degradation and reduce its stability over time. Therefore, monitoring and controlling impurity levels are crucial to maintaining the drug's stability and extending its shelf life.
DCM or DMSO are the solvents used for analyzing many impurities in Deferasirox.
Deferasirox impurities are stored at a controlled room temperature between 2-8 °C or as indicated on the Certificate of Analysis (CoA).
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