Description

Gefitinib 3,4-Difluoro Impurity is a designated impurity of the active pharmaceutical ingredient Gefitinib, a tyrosine kinase inhibitor used in cancer therapy. This specific impurity is critical for pharmaceutical manufacturers to monitor and control to ensure the safety, efficacy, and regulatory compliance of the final drug product. It is primarily required by analytical laboratories, quality control departments, and R&D teams within the pharmaceutical and biotechnology sectors for method development, validation, and reference standard qualification.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Gefitinib drug substance and finished products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to accurately detect and quantify this specific impurity.
• Quality Control & Assurance: Serves as a system suitability standard and for impurity profiling to ensure batch-to-batch consistency and compliance with ICH Q3A/B guidelines.
• Stability Studies: Employed to monitor the formation of degradation impurities in Gefitinib formulations under various stress conditions.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and control strategies.
• Research & Development: Used in synthetic chemistry research to study the formation pathways and chemical behavior of this impurity.

Basic Information

Product Name	Gefitinib 3,4-Difluoro Impurity
CAS No.	184475-50-1
Molecular Formula	C22H24ClF2N4O3
Molecular Weight	465.90 g/mol
Synonyms	Gefitinib Difluoro Impurity; Gefitinib Impurity 3,4-Difluoro; 3,4-Difluoro Gefitinib Impurity; N-(3-Chloro-4-fluorophenyl)-7-methoxy-6-[3-(4-morpholinyl)propoxy]-4-quinazolinamine 3,4-Difluoro Analog; Gefitinib Related Compound 3,4-Difluoro; ZD1839 3,4-Difluoro Impurity; Iressa 3,4-Difluoro Impurity
EINECS	Contact for details

Quality Control

Every batch of Gefitinib 3,4-Difluoro Impurity is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our quality commitment aligns with cGMP principles for pharmaceutical impurities. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from tests including HPLC purity, related substances, residual solvents, and spectroscopic identification (IR, MS, NMR).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to maintain 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 ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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