Description

Erlotinib Impurity 67 CAS NO 1494468-76-6 is a high-purity chemical reference standard used for the analytical profiling and quality control of the active pharmaceutical ingredient Erlotinib. 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, stability studies, and batch release testing within the pharmaceutical and life sciences sectors.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the quality control and release testing of Erlotinib Hydrochloride drug substance and drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to accurately quantify impurities in Erlotinib.
• Stability Studies & Forced Degradation: Employed to identify and monitor degradation products formed under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity data for health authorities like the US FDA and EMA.
• Research & Development: Used in R&D laboratories for studying the metabolic pathways, degradation chemistry, and impurity formation mechanisms of Erlotinib.
• Pharmacopoeial Testing: Aids in compliance testing against monographs in pharmacopoeias such as USP, EP, or BP where impurity profiles are specified.

Basic Information

Product Name	Erlotinib Impurity 67
CAS No.	1494468-76-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Erlotinib Related Compound 67; Erlotinib Impurity 67; Erlotinib EP Impurity 67; Erlotinib USP Impurity 67; Tarceva Impurity 67; N-(3-Ethynylphenyl)-6,7-bis(2-methoxyethoxy)quinazolin-4-amine Impurity; 4-Quinazolinamine, N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-, Impurity
EINECS	Contact for details

Quality Control

Our Erlotinib Impurity 67 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant specifications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container should be kept in a desiccated environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

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

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