Description

Gefitinib Impurity CAS NO 1608115-59-8 is a high-purity chemical reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Gefitinib. This impurity is critical for pharmaceutical manufacturers and research laboratories to ensure drug safety, efficacy, and regulatory compliance. It is primarily required by professionals in pharmaceutical development, quality assurance (QA), and quality control (QC) for method validation, stability studies, and impurity identification.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Gefitinib API and finished drug products.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating chromatographic methods, such as HPLC and UPLC, to meet ICH Q2(R1) guidelines.
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies to monitor impurity profiles and ensure drug product shelf-life.
• Quality Control & Batch Release: A critical component in the routine QC testing of Gefitinib batches to confirm they meet stringent pharmacopeial specifications (e.g., USP, EP).
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Research & Development: Used in academic and industrial R&D to study the degradation pathways and metabolism of Gefitinib.

Basic Information

Product Name	Gefitinib Impurity
CAS No.	1608115-59-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Gefitinib Related Compound; Gefitinib Specified Impurity; Gefitinib Process Impurity; Gefitinib Degradant; (3-Chloro-4-fluorophenyl)[7-methoxy-6-[3-(4-morpholinyl)propoxy]-4-quinazolinyl]amine Impurity; ZD1839 Impurity; Iressa Impurity
EINECS	Contact for details

Quality Control

Every batch of Gefitinib Impurity (CAS 1608115-59-8) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with industry standards and customer specifications. A comprehensive Certificate of Analysis (COA), detailing purity, identity, and impurity profile, is provided with each shipment and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the product label or COA. The material should be kept in a dry environment to prevent moisture uptake. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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