Description

Gefitinib Intermediate B CAS NO 912556-91-3 is a critical high-purity chemical building block used in the synthesis of targeted cancer therapeutics. This advanced intermediate is essential for ensuring the structural integrity and efficacy of the final active pharmaceutical ingredient (API). It is primarily required by pharmaceutical manufacturers and contract research organizations (CROs) engaged in the development and production of tyrosine kinase inhibitor drugs.

Application

• Pharmaceutical Synthesis: Key intermediate in the multi-step synthesis of Gefitinib API, a targeted therapy for non-small cell lung cancer (NSCLC).
• Oncology Drug Development: Used in research and process development for novel Epidermal Growth Factor Receptor (EGFR) inhibitor candidates.
• Contract Manufacturing: Sourced by CDMOs (Contract Development and Manufacturing Organizations) for cGMP-compliant production batches.
• Process Optimization: Employed in scaling up and optimizing synthetic routes for improved yield and purity in commercial manufacturing.
• Reference Standard: Serves as a high-purity standard for analytical method development and quality control during API production.

Basic Information

Product Name	Gefitinib Intermediate B
CAS No.	912556-91-3
Molecular Formula	C19H21ClFN3O3
Molecular Weight	393.84 g/mol
Synonyms	6,7-Dimethoxy-4-[(3-chloro-4-fluorophenyl)amino]quinazoline; N-(3-Chloro-4-fluorophenyl)-6,7-dimethoxyquinazolin-4-amine; Gefitinib Impurity; Gefitinib Related Compound B; ZD1839 Intermediate; Iressa Intermediate; EGFR Inhibitor Intermediate; 4-Quinazolinamine, N-(3-chloro-4-fluorophenyl)-6,7-dimethoxy-
EINECS	Contact for details

Quality Control

Our Gefitinib Intermediate B is manufactured under strict quality management systems to meet the exacting standards of pharmaceutical applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles. We ensure compliance with relevant ICH guidelines and support our clients' regulatory filings with consistent, traceable quality.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at a controlled room temperature (typically 15-25°C). This material is moisture-sensitive (hygroscopic) and should be handled under an inert atmosphere when appropriate to maintain stability.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.5%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Loss on Drying	≤ 0.5%
Heavy Metals	≤ 20 ppm

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