Description

Deferasirox Impurity CAS NO 1688656-83-8 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 (API) 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 this well-characterized impurity is essential for maintaining strict compliance with global pharmacopeial standards.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Deferasirox API and finished drug products.
• Analytical Method Development: Serves as a critical standard for developing and validating HPLC, UPLC, and LC-MS methods in quality control laboratories.
• Stability Studies: Employed to monitor the formation and levels of this impurity during forced degradation and long-term stability testing of Deferasirox formulations.
• Regulatory Compliance & Filing: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Quality Assurance/Quality Control (QA/QC): Used for routine batch release testing to ensure Deferasirox products meet specified purity criteria and pharmacopeial monographs (USP, EP).
• Research & Development: Utilized in synthetic chemistry R&D to study the formation pathways and to develop purification processes for the main API.

Basic Information

Product Name	Deferasirox Impurity
CAS No.	1688656-83-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Deferasirox Related Compound; Deferasirox Process Impurity; Deferasirox Specified Impurity; 4-[3,5-Bis(2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]benzoic Acid Impurity; ICL670 Impurity; EXJADE Impurity; Jadenu Impurity; Deferasirox Analog
EINECS	Contact for details

Quality Control

Every batch of Deferasirox Impurity (CAS 1688656-83-8) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with cGMP, ICH Q3A/B guidelines, and relevant pharmacopeial requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. Keep the container in a dry, cool, and well-ventilated place. For long-term storage, consider storing under inert atmosphere to ensure stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH limits
Water Content (KF)	≤ 5.0%

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