Description

Deferasirox Impurity 5 is a high-purity chemical reference standard used for analytical and research purposes. This compound is a specified impurity of Deferasirox, an iron chelator medication, and is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The availability of this well-characterized impurity standard is essential for compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Deferasirox Impurity 5 in Deferasirox API and finished drug products.
• Analytical Method Development: Essential for developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance: Employed in routine batch testing to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions.
• Research & Development: Facilitates studies on the degradation pathways and metabolism of Deferasirox.

Basic Information

Item	Detail
Product Name	Deferasirox Impurity 5
CAS No.	524746-11-0
Molecular Formula	C21H15N3O4
Molecular Weight	373.36 g/mol
Synonyms	4-[3,5-Bis(2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]benzoic acid; Deferasirox Related Compound B; Deferasirox Impurity B; Deferasirox EP Impurity B; Deferasirox USP Impurity 5; EXJADE Impurity 5; ICL670A Impurity 5
EINECS	Contact for details

Quality Control

Every batch of Deferasirox Impurity 5 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques to ensure compliance with pharmacopeial standards (USP, EP). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, residual solvents, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Handle under an inert atmosphere if necessary for prolonged operations.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC)	≥ 98.5%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.