Description

Icotinib Impurity 1 CAS NO 1058651-74-3 is a high-purity reference standard used for the analytical profiling and quality control of the active pharmaceutical ingredient Icotinib. This impurity is critical for pharmaceutical manufacturers and research laboratories to ensure drug safety, efficacy, and regulatory compliance. It is primarily utilized in method development, validation, and stability studies within the pharmaceutical and analytical chemistry sectors.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quality control and release testing of Icotinib API batches.
• Analytical Method Development: Used to develop and validate HPLC, UPLC, or LC-MS methods for impurity profiling and quantification.
• Stability Studies: Employed as a marker to monitor degradation pathways and establish the shelf-life of Icotinib drug products.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require impurity identification and characterization data.
• Research & Development: Used in synthetic chemistry R&D to study the formation and fate of this specific impurity during the manufacturing process.
• Pharmacopoeial Testing: Supports testing in alignment with pharmacopoeial monographs that specify impurity limits.

Basic Information

Product Name	Icotinib Impurity 1
CAS No.	1058651-74-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Icotinib Related Compound 1; Icotinib Impurity A; Icotinib EP Impurity A; Icotinib USP Impurity; (3R)-N-(3-Ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine Impurity 1; BPI-2009H Impurity 1; Conmana Impurity 1
EINECS	Contact for details

Quality Control

Our Icotinib Impurity 1 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity and identity confirmation, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing purity, assay, and impurity profile is provided with every shipment to support your quality and regulatory requirements.

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.

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 guidelines

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