Description

Erlotinib Impurity 2 is a designated pharmaceutical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Erlotinib by serving as a key marker for impurity profiling and control. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in drug development and quality assurance. The use of this well-characterized impurity standard is essential for compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Erlotinib API and finished drug products.
• Analytical Method Development and Validation: Critical for developing, optimizing, and validating chromatographic methods (HPLC, UPLC) used in quality control laboratories.
• Stability Studies: Employed to monitor the formation of degradation products in Erlotinib under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance and Filing: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Quality Control (QC) Testing: Used as a system suitability and calibration standard in routine QC testing of Erlotinib batches to ensure they meet specified purity limits.
• Research and Development: Supports R&D activities aimed at understanding the degradation pathways and synthesis by-products of Erlotinib.

Basic Information

Product Name	Erlotinib Impurity 2
CAS No.	299912-59-7
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 B; Erlotinib USP Related Compound; Tarceva Impurity; CP-358774 Impurity; NSC 718781 Impurity; EGFR Inhibitor Impurity
EINECS	Contact for details

Quality Control

Our Erlotinib Impurity 2 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, MS, NMR), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment to support your regulatory and quality needs.

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); ensure the container is sealed tightly after each use to prevent absorption of 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)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 0.5% w/w
Residue on Ignition	≤ 0.1%

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