Description

Icotinib Impurity 2 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Icotinib. This compound is critical for ensuring the purity, safety, and efficacy of Icotinib-based drug products by serving as a reference marker in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, method development, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Icotinib API and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): A critical component in routine batch release testing to ensure drug substance and product meet stringent pharmacopeial specifications (e.g., ICH Q3A/B).
• Stability Studies: Employed to track the formation and level of this specific impurity under various stress and long-term storage conditions.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and to support process optimization and impurity control strategies.

Basic Information

Product Name	Icotinib Impurity 2
CAS No.	2218487-28-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Icotinib Related Compound 2; Icotinib Impurity B; Icotinib EP Impurity B; Icotinib USP Impurity; 4-Quinazolinamine, N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-, Impurity; BPHA Impurity; Conmana Impurity
EINECS	Contact for details

Quality Control

Our Icotinib Impurity 2 is manufactured under strict quality management systems. Each batch is characterized and qualified using advanced analytical techniques including HPLC, LC-MS, and NMR to ensure high purity and accurate identification. Certificates of Analysis (COA) are provided, detailing comprehensive analytical results and confirming compliance with relevant standards. Our quality commitment supports regulatory requirements for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as specified on the certificate of analysis. Keep the container in a dry, cool, and well-ventilated place. Handle and store under an inert atmosphere if specified.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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