Description

Icotinib Impurity 7 is a specified impurity associated with the active pharmaceutical ingredient Icotinib, a tyrosine kinase inhibitor used in cancer therapy. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, quality control, and regulatory compliance. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in the synthesis, purification, and quality assurance of Icotinib.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Icotinib active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to ensure accurate impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity levels and ensure drug substance and product meet stringent pharmacopeial specifications (e.g., ICH Q3A/B).
• Regulatory Compliance and Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing necessary impurity characterization and control data.
• Stability Studies: Used to track the formation and level of this specific impurity during forced degradation and long-term stability studies of Icotinib formulations.
• Process Chemistry Research: Aids chemists in understanding and optimizing the Icotinib synthesis pathway to minimize the formation of this impurity.

Basic Information

Product Name	Icotinib Impurity 7
CAS No.	2221937-43-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Icotinib Related Compound 7; Icotinib Impurity C; Icotinib EP Impurity C; Icotinib Process Impurity; 4-Quinazolinamine, N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-, Impurity 7; BPHA-132 Impurity 7; Conmana Impurity 7
EINECS	Contact for details

Quality Control

Every batch of Icotinib Impurity 7 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing using advanced analytical techniques to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results against predefined specifications. Our quality commitment aligns with ICH guidelines and relevant pharmacopeial standards to support your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Handle and store under inert atmosphere if specified.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 3.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.1%

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