Description

Erlotinib is a potent and selective small-molecule inhibitor of the epidermal growth factor receptor (EGFR) tyrosine kinase domain. This targeted therapeutic agent is crucial for disrupting the signaling pathways that drive the proliferation and survival of certain cancer cells. It is primarily required by pharmaceutical manufacturers and research institutions engaged in oncology drug development and production.

Application

• Active Pharmaceutical Ingredient (API): Core component in the formulation of targeted cancer therapeutics.
• Oncology Research: Critical reference standard and biochemical tool for studying EGFR signaling pathways and mechanisms of drug resistance.
• Pharmaceutical Development: Used in pre-formulation studies, stability testing, and the development of generic and novel drug products.
• Quality Control Laboratories: Serves as a high-purity analytical standard for HPLC, LC-MS, and other pharmacopeial testing methods.
• Clinical Trial Material: Supplied under GMP guidelines for use in Phase I-III clinical studies.

Basic Information

Product Name	Erlotinib
CAS No.	183322-38-5
Molecular Formula	C22H23N3O4
Molecular Weight	393.44 g/mol
Synonyms	Erlotinib Hydrochloride (salt form); CP-358774; OSI-774; N-(3-Ethynylphenyl)-6,7-bis(2-methoxyethoxy)quinazolin-4-amine; Tarceva (Trade Name); 6,7-Bis(2-methoxyethoxy)quinazolin-4-yl-(3-ethynylphenyl)amine; NSC 718781
EINECS	Contact for details

Quality Control

Our Erlotinib is manufactured and tested to meet stringent quality standards appropriate for pharmaceutical applications. Each batch is supported by a comprehensive Certificate of Analysis (COA) that includes identity confirmation, purity assay, and impurity profiling. We adhere to relevant ICH guidelines and can supply material suitable for use under current Good Manufacturing Practice (cGMP) conditions for advanced research and development.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and potency.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	≥98.5%
Related Substances (HPLC)	Total impurities ≤1.5% Any single unknown impurity ≤0.5%
Water Content (KF)	≤0.5%
Residue on Ignition	≤0.1%
Heavy Metals	≤20 ppm

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