Description

Deferasirox Impurity 13 is a specified impurity of the iron-chelating pharmaceutical agent Deferasirox. This compound is critical for analytical research and quality control in pharmaceutical development and manufacturing. It is primarily used by researchers and quality assurance professionals in the pharmaceutical industry to ensure the purity, safety, and efficacy of Deferasirox drug substances and products.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Deferasirox Impurity 13 in active pharmaceutical ingredients (APIs) and finished drug products.
• Method Development and Validation: Used in the development, optimization, and validation of analytical methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing in pharmaceutical manufacturing to monitor and control impurity levels, ensuring compliance with ICH guidelines.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions, supporting drug shelf-life determination.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough understanding and control of the drug's impurity profile.
• Research and Development: Used in synthetic chemistry and process research to understand and minimize the formation of this impurity during the API synthesis.

Basic Information

Product Name	Deferasirox Impurity 13
CAS No.	524746-12-1
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; Deferasirox EP Impurity; Deferasirox USP Impurity; ICL670A Impurity; EXJADE Impurity; Desferasirox Impurity; Benzoic acid, 4-[3,5-bis(2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]-
EINECS	Contact for details

Quality Control

Our Deferasirox Impurity 13 is manufactured under strict quality systems to ensure high purity and batch-to-batch consistency, suitable for use as a reference standard. Each batch undergoes comprehensive analytical characterization using techniques including HPLC, NMR, and MS. A detailed Certificate of Analysis (COA) providing purity, identification data, and chromatographic profiles is supplied with every shipment to support your regulatory and quality requirements.

Storage

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

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)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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