Description

Gefitinib Impurity 1 CAS NO 1561173-24-7 is a specified impurity of Gefitinib, a tyrosine kinase inhibitor used in targeted cancer therapy. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method validation and quality control of the active pharmaceutical ingredient (API). It is essential for analytical chemists, quality assurance professionals, and R&D scientists in the pharmaceutical industry who require high-purity chemical standards to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Gefitinib impurities in drug substances and products.
• Analytical Method Development: Crucial for developing and validating HPLC, UPLC, and LC-MS methods to monitor impurity profiles during API synthesis.
• Quality Control & Assurance: Used in in-process testing and release testing of Gefitinib API to ensure compliance with pharmacopeial limits (e.g., ICH Q3A/B guidelines).
• Stability Studies: Employed to track the formation of degradation products in Gefitinib formulations under various storage conditions.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Gefitinib to minimize impurity generation.

Basic Information

Product Name	Gefitinib Impurity 1
CAS No.	1561173-24-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Gefitinib Related Compound 1; Gefitinib Impurity A; Gefitinib EP Impurity A; Gefitinib USP Impurity; N-(3-Chloro-4-fluorophenyl)-7-methoxy-6-(3-morpholinopropoxy)quinazolin-4-amine Impurity; 4-Quinazolinamine, N-(3-chloro-4-fluorophenyl)-7-methoxy-6-[3-(4-morpholinyl)propoxy]- (Impurity); ZD1839 Impurity 1; Iressa Impurity 1
EINECS	Contact for details

Quality Control

Every batch of Gefitinib Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality requirements.

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. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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