Description

Deferasirox Impurity 12 is a designated impurity standard of the iron-chelating pharmaceutical agent Deferasirox. This high-purity reference material is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is primarily required by pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and contract research organizations (CROs) to ensure the safety, efficacy, and regulatory compliance of Deferasirox drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Deferasirox Active Pharmaceutical Ingredient (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 release testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines.
• Stability Studies: Used to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) as part of drug stability testing.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and control strategies.
• Pharmacopoeial Testing: Supports testing in compliance with pharmacopoeial monographs (USP, EP, BP) for Deferasirox.

Basic Information

Product Name	Deferasirox Impurity 12
CAS No.	1688656-86-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Deferasirox Related Compound 12; Deferasirox Impurity; 4-[3,5-Bis(2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]benzoic acid impurity; EXJADE Impurity 12; ICL670 Impurity 12; Deferasirox EP Impurity I; Deferasirox Process Impurity
EINECS	Contact for details

Quality Control

Our Deferasirox Impurity 12 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical characterization using techniques such as HPLC, NMR, and MS to confirm identity and purity. We provide full traceability and Certificates of Analysis (COA) are supplied with every shipment, detailing batch-specific results. Our quality standards align with the requirements for pharmaceutical reference materials.

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 (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 solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Report and comply with COA
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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