Description

Gefitinib 3,4-Difluoro Impurity Hcl is a high-purity chemical reference standard specifically designed for analytical and quality control purposes in pharmaceutical development. This compound is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient Gefitinib by accurately quantifying and controlling its related substances. It is an essential tool for analytical chemists, quality assurance professionals, and researchers working in pharmaceutical manufacturing and regulatory compliance. The product is supplied with comprehensive analytical data to support method validation and regulatory filings.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the calibration and validation of analytical methods (e.g., HPLC, LC-MS) used in drug substance and drug product testing.
• Quality Control & Assurance: Critical for establishing specification limits and monitoring the levels of this specific difluoro impurity during the synthesis and purification of Gefitinib API to ensure batch-to-batch consistency.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing a characterized impurity for identification, qualification, and toxicological assessment.
• Research & Development: Used in process chemistry research to study the formation and fate of this impurity, aiding in the optimization of synthetic routes and purification processes for Gefitinib.
• Method Development: Serves as a key component in developing, transferring, and verifying stability-indicating assay methods for Gefitinib and its related substances.

Basic Information

Product Name	Gefitinib 3,4-Difluoro Impurity Hcl
CAS No.	184475-68-1
Molecular Formula	C22H24ClF2N4O3
Molecular Weight	465.90 g/mol
Synonyms	Gefitinib Difluoro Impurity Hcl; Gefitinib Related Compound Hcl; 3,4-Difluoro Gefitinib Impurity Hydrochloride; N-(3-Chloro-4-fluorophenyl)-7-methoxy-6-[3-(morpholin-4-yl)propoxy]quinazolin-4-amine 3,4-Difluoro Impurity Hydrochloride; Gefitinib Impurity F Hcl (3,4-Difluoro); Gefitinib EP Impurity H Hcl; Gefitinib USP Related Substance Hcl; ZD1839 Impurity Hcl
EINECS	Contact for details

Quality Control

Every batch of Gefitinib 3,4-Difluoro Impurity Hcl is manufactured and analyzed under strict quality management systems. It undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure it meets the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with the principles of cGMP and supports compliance with ICH guidelines (Q3A, Q3B) for impurities.

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); the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC, Area %)	≥ 98.0%
Assay (on dried basis)	97.0% - 102.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual unknown impurity ≤ 0.10% Total impurities ≤ 1.0%

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