Description

Icotinib Impurity 5 is a specified impurity of Icotinib, a tyrosine kinase inhibitor used in targeted cancer therapy. This impurity is a critical reference standard for pharmaceutical research and development, essential for ensuring drug safety, efficacy, and regulatory compliance. It is primarily required by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies for method development, validation, and quality control of Icotinib active pharmaceutical ingredients (APIs) and finished drug products.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of impurities in Icotinib API and formulations.
• Analytical Method Development: Used in HPLC, LC-MS, and other chromatographic methods to establish impurity profiles and validate analytical procedures.
• Quality Control & Assurance: Critical for batch release testing to monitor and control impurity levels, ensuring product meets pharmacopeial standards (e.g., ICH Q3A/B).
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs).
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress and long-term storage conditions.
• Research & Process Chemistry: Aids in understanding the degradation pathways and synthesis by-products of Icotinib, helping to optimize manufacturing processes.

Basic Information

Product Name	Icotinib Impurity 5
CAS No.	1318600-04-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Icotinib Related Compound 5; Icotinib EP Impurity 5; Icotinib USP Impurity 5; Icotinib Process Impurity 5; 4-Quinazolinamine, N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-, Impurity; BPHA Impurity 5; Conmana Impurity 5
EINECS	Contact for details

Quality Control

Every batch of Icotinib Impurity 5 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, LC-MS, NMR) to ensure compliance with pharmacopeial standards and ICH guidelines. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or 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 ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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