Description

Deferasirox Impurity 14 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient Deferasirox, an iron chelator. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The availability of a 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 impurities in Deferasirox API and finished drug products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles in accordance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance: Serves as a system suitability standard in routine QC testing to ensure batch-to-batch consistency and compliance with drug substance specifications.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and marketing authorization applications.
• Stability Studies: Employed to track the formation and levels of this specific impurity during forced degradation and long-term stability studies of Deferasirox formulations.
• Research & Development: Used in academic and industrial R&D to study the degradation pathways, metabolism, and toxicological profile of Deferasirox.

Basic Information

Product Name	Deferasirox Impurity 14
CAS No.	524746-13-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Deferasirox Related Compound 14; Deferasirox EP Impurity I; Deferasirox USP Impurity; 4-[3,5-Bis(2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]benzoic acid Impurity; ICL670 Impurity 14; EXJADE Impurity; Desferasirox Impurity; Deferasirox Degradation Product
EINECS	Contact for details

Quality Control

Our Deferasirox Impurity 14 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing the results against relevant specifications. We support compliance with ICH, USP, and EP guidelines.

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. The container should be sealed under an inert atmosphere if specified.

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)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
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.