Description

Erlotinib Impurity 81 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, contract research organizations (CROs), and regulatory bodies focused on ensuring the purity, safety, and efficacy of Erlotinib-based drug products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Erlotinib Impurity 81 in drug substances and products.
• Analytical Method Development: Crucial for developing and validating HPLC, UPLC, and LC-MS methods to monitor impurity profiles in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance: Used in routine QC testing of Erlotinib API and finished dosage forms to ensure impurity levels remain within specified safety thresholds.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of drug stability profiling.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing characterized impurity data.
• Process Chemistry Research: Aids in understanding and optimizing the Erlotinib synthesis pathway to minimize the formation of this impurity.

Basic Information

Item	Details
Product Name	Erlotinib Impurity 81
CAS No.	53666-33-4
Molecular Formula	C22H23N3O4
Molecular Weight	393.44 g/mol
Synonyms	N-(3-Ethynylphenyl)-6,7-bis(2-methoxyethoxy)quinazolin-4-amine; Erlotinib Related Compound; Erlotinib EP Impurity; Tarceva Impurity; CP-358774 Impurity; NSC 718781; 4-Quinazolinamine, N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-
EINECS	Contact for details

Quality Control

Every batch of Erlotinib Impurity 81 is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances and residual solvents. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results against predefined specifications. Our quality standards align with the requirements for pharmaceutical reference materials.

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 dry, inert conditions to maintain stability and purity. The container should be sealed tightly after each use to minimize exposure to atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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