Description

Icotinib Impurity 6 CAS NO 1318600-03-1 is a specified impurity of Icotinib, a tyrosine kinase inhibitor used in targeted cancer therapy. This compound is critical for pharmaceutical research and development, serving as a reference standard for analytical method development, validation, and quality control of the active pharmaceutical ingredient (API). It is essential for manufacturers, analytical laboratories, and regulatory bodies focused on ensuring the purity, safety, and efficacy of Icotinib-based drug products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Icotinib Impurity 6 in drug substances and products.
• Analytical Method Development: Crucial for developing and validating chromatographic methods (e.g., HPLC, UPLC) to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to ensure Icotinib API and finished drug formulations meet stringent pharmacopeial (e.g., USP, EP, ChP) and ICH Q3A/B guidelines.
• Stability Studies: Employed to track the formation of this impurity under various stress conditions (heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing impurity characterization data.
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Icotinib to minimize the formation of this specific impurity.

Basic Information

Product Name	Icotinib Impurity 6
CAS No.	1318600-03-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Icotinib Related Compound 6; Icotinib Impurity C; Icotinib EP Impurity C; Icotinib USP Impurity; 4-Quinazolinamine, N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-, Impurity; Conmana Impurity 6; BPI-2009H Impurity 6
EINECS	Contact for details

Quality Control

Every batch of Icotinib Impurity 6 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, impurities, and identification. We support compliance with ICH Q3A, Q3B, USP, and EP guidelines.

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 must be kept under inert conditions or in a desiccator to maintain stability and purity. For long-term storage, consider storing at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
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.