Description

Erlotinib Impurity 20 is a designated 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 processes. 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 finished dosage forms.
• Analytical Method Development: Critical for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles during API synthesis and formulation.
• Quality Control & Assurance: Employed in routine QC testing to ensure batch-to-batch consistency and compliance with ICH Q3A/B guidelines on impurities.
• Stability Studies: Used to track the formation of degradation products in Erlotinib under various stress conditions (e.g., 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 synthesis pathways to minimize the formation of this specific impurity.

Basic Information

Product Name	Erlotinib Impurity 20
CAS No.	236750-62-2
Molecular Formula	C22H23N3O4
Molecular Weight	393.44 g/mol
Synonyms	Erlotinib Related Compound 20; N-(3-Ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine Impurity; Tarceva Impurity 20; 6,7-Bis(2-methoxyethoxy)quinazolin-4-amine, N-(3-ethynylphenyl)-; Erlotinib EP Impurity I; Erlotinib USP Impurity; (3-Ethynylphenyl)-[6,7-bis(2-methoxyethoxy)quinazolin-4-yl]amine
EINECS	Contact for details

Quality Control

Our Erlotinib Impurity 20 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity confirmation and structural elucidation via NMR and MS, to ensure it meets the stringent requirements for use as a reference standard. Certificates of Analysis (COA) are provided, detailing batch-specific results and traceability. Our quality commitment aligns with cGMP principles and supports compliance with major pharmacopoeial standards (USP, EP).

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 product 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 (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.5%

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