Description

Gefitinib Impurity 14 is a specified organic impurity used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Gefitinib. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of the final drug product. It serves as a key reference standard for method development, validation, and routine batch analysis in the production of Gefitinib, a tyrosine kinase inhibitor used in cancer therapy.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Gefitinib API.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in-house by API manufacturers to comply with ICH Q3A(R2) and Q3B(R2) guidelines on impurities.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing impurity characterization data.
• Stability Studies: Employed to track the formation of this specific impurity during forced degradation and long-term stability testing of Gefitinib.
• Research & Development: Used in synthetic chemistry R&D to understand and control impurity formation pathways during the API synthesis process.

Basic Information

Product Name	Gefitinib Impurity 14
CAS No.	199327-59-8
Molecular Formula	C22H24ClFN4O3
Molecular Weight	446.90 g/mol
Synonyms	Gefitinib Related Compound 14; Gefitinib EP Impurity G; Gefitinib USP Impurity; 4-Quinazolinamine, N-(3-chloro-4-fluorophenyl)-7-methoxy-6-[3-(4-morpholinyl)propoxy]-, Hydrochloride; Gefitinib Hydrochloride Impurity; ZD1839 Impurity 14; Iressa Impurity 14
EINECS	Contact for details

Quality Control

Every batch of Gefitinib Impurity 14 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic (HPLC, UPLC) and spectroscopic (MS, NMR) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

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) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm
Single Unknown Impurity (HPLC)	≤ 1.0%
Total Impurities (HPLC)	≤ 5.0%

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