Description

Gefitinib Impurity 35 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient Gefitinib during its development and manufacturing. It is primarily required by pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs departments for method validation, impurity profiling, and compliance documentation.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the calibration of analytical instruments and validation of testing methods (e.g., HPLC, LC-MS).
• Impurity Profiling & Identification: Used in the identification, quantification, and characterization of impurities in Gefitinib API batches to meet ICH Q3A(R2) and Q3B(R2) guidelines.
• Method Development & Validation: Essential for developing and validating stability-indicating assay methods and forced degradation studies for Gefitinib.
• Quality Control & Assurance: Employed in routine QC testing to monitor and control impurity levels throughout the drug substance manufacturing process.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Supports pharmacokinetic, metabolic, and toxicological studies to understand the impurity's impact.

Basic Information

Product Name	Gefitinib Impurity 35
CAS No.	861453-12-5
Molecular Formula	C22H24ClFN4O3
Molecular Weight	446.90 g/mol
Synonyms	N-(3-Chloro-4-fluorophenyl)-7-methoxy-6-[3-(morpholin-4-yl)propoxy]quinazolin-4-amine; Gefitinib Chloro Impurity; Gefitinib Related Compound 35; 4-Quinazolinamine, N-(3-chloro-4-fluorophenyl)-7-methoxy-6-[3-(4-morpholinyl)propoxy]-; Iressa Impurity 35; ZD1839 Impurity 35
EINECS	Contact for details

Quality Control

Every batch of Gefitinib Impurity 35 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from advanced analytical techniques such as HPLC, NMR, and MS.

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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