Description

Deferasirox Impurity 15 is a designated impurity of the iron-chelating pharmaceutical agent Deferasirox. This compound is critical for analytical reference and quality control processes in pharmaceutical development and manufacturing. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and analytical laboratories for method validation, stability studies, and ensuring batch-to-batch consistency of the active pharmaceutical ingredient (API).

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Deferasirox API and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, calibrating, and validating chromatographic methods to monitor impurity profiles.
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies to track the formation of this specific impurity over time and under various stress conditions.
• Quality Control & Batch Release Testing: Serves as a system suitability standard in routine QC testing to ensure API and drug product purity meets pharmacopeial (e.g., USP, EP) and internal specifications.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specification limits.
• Research & Development: Used in R&D to understand the degradation pathways and synthesis by-products of Deferasirox.

Basic Information

Product Name	Deferasirox Impurity 15
CAS No.	1688656-84-9
Molecular Formula	C21H15N3O4
Molecular Weight	373.36 g/mol
Synonyms	Deferasirox Related Compound 15; 2-[3,5-Bis(2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]benzoic acid Impurity; 4-[3,5-Bis(2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]benzoic acid (Isomer of Deferasirox); ICL670 Impurity 15; EXJADE Impurity 15; 1H-1,2,4-Triazole, 3,5-bis(2-hydroxyphenyl)-1-(2-carboxyphenyl)-; Deferasirox EP Impurity C
EINECS	Contact for details

Quality Control

Our Deferasirox Impurity 15 is manufactured and controlled under a strict quality management system. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment to support your regulatory and quality assurance requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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