Description

Erlotinib Impurity 3 is a specified impurity of the active pharmaceutical ingredient Erlotinib Hydrochloride, a tyrosine kinase inhibitor used in cancer therapy. This compound is critical for pharmaceutical research and development, serving as a reference standard for analytical method development, validation, and quality control. It is essential for manufacturers and analytical laboratories focused on ensuring the purity, safety, and regulatory compliance of Erlotinib drug substances and finished products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Erlotinib Hydrochloride API and its formulations.
• Analytical Method Development: Critical for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles during drug synthesis and stability studies.
• Quality Control & Assurance: Employed in routine QC testing of batches to ensure compliance with pharmacopeial limits (e.g., ICH Q3A/B, USP, EP) for specified impurities.
• Stability Studies: Used to track the formation and level of this specific degradation product under various stress conditions (heat, light, humidity).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Aids in optimizing synthetic routes and purification processes to minimize the formation of this impurity.

Basic Information

Product Name	Erlotinib Impurity 3
CAS No.	328528-74-1
Molecular Formula	C22H23N3O4
Molecular Weight	393.44 g/mol
Synonyms	N-(3-Ethynylphenyl)-6,7-bis(2-methoxyethoxy)quinazolin-4-amine; Erlotinib N-Oxide Impurity; Erlotinib Related Compound 3; Tarceva Impurity 3; OSI-774 Impurity 3; CP-358774 Impurity 3; 6,7-Bis(2-methoxyethoxy)-N-(3-ethynylphenyl)quinazolin-4-amine
EINECS	Contact for details

Quality Control

Our Erlotinib Impurity 3 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and stability. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from HPLC, NMR, and MS analyses. We adhere to relevant ICH guidelines and can support compliance with cGMP standards for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
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.