Description

Deferasirox Impurity 8 is a designated impurity standard of the iron-chelating pharmaceutical agent Deferasirox. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) during development and manufacturing. It is primarily required by pharmaceutical companies, analytical laboratories, and regulatory bodies for quality control and method validation purposes. The availability of a well-characterized impurity standard is essential for meeting stringent global regulatory requirements for drug substances.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Deferasirox Impurity 8 in API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods in quality control laboratories.
• Stability Studies: Employed to monitor the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Regulatory Compliance & Filings: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing necessary impurity profile data.
• Process Chemistry Research: Aids in optimizing synthesis and purification processes to minimize the formation of this impurity.
• Pharmacopoeial Testing: Used for testing against monographs in pharmacopoeias such as USP, EP, or BP where this impurity is specified.

Basic Information

Product Name	Deferasirox Impurity 8
CAS No.	201530-78-1
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 8; Deferasirox Impurity C; EXJADE Impurity 8; ICL670 Impurity 8; 4-{3,5-Bis(2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl}benzoic Acid; Benzoic acid, 4-[3,5-bis(2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]-
EINECS	Contact for details

Quality Control

Our Deferasirox Impurity 8 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure high purity and identity. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results for purity, related substances, and identification. Our quality systems are designed to support pharmaceutical research and regulatory compliance. Certificates of Analysis (COA) are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere to ensure stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 3.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.2%

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