Description

Erlotinib Hydrochloride CAS NO 183319-69-9 is a small-molecule tyrosine kinase inhibitor that specifically targets the epidermal growth factor receptor (EGFR). This high-purity active pharmaceutical ingredient (API) is critical for the development and manufacturing of targeted cancer therapeutics. It is primarily required by pharmaceutical companies and research institutions engaged in oncology drug development, formulation, and clinical studies.

Application

• Pharmaceutical API: Primary active ingredient in the formulation of anti-cancer medications, specifically for the treatment of non-small cell lung cancer (NSCLC) and pancreatic cancer.
• Oncology Research: A key reference standard and tool compound for in vitro and in vivo studies investigating EGFR signaling pathways, drug resistance mechanisms, and combination therapies.
• Drug Development: Used in pre-clinical and clinical development stages for new dosage forms, including tablets, capsules, and novel drug delivery systems.
• Generic Drug Manufacturing: Serves as the core component for companies producing bioequivalent versions of established EGFR inhibitor therapies.
• Quality Control & Analytical Testing: Employed as a certified reference standard in HPLC, LC-MS, and other analytical methods for assay and impurity profiling of drug products.

Basic Information

Product Name	Erlotinib Hydrochloride
CAS No.	183319-69-9
Molecular Formula	C22H23N3O4 • HCl
Molecular Weight	429.90 g/mol (as hydrochloride salt)
Synonyms	Erlotinib HCl; N-(3-Ethynylphenyl)-6,7-bis(2-methoxyethoxy)quinazolin-4-amine hydrochloride; CP-358774; OSI-774; Tarceva (brand name active ingredient); NSC 718781; EGFR Tyrosine Kinase Inhibitor
EINECS	Contact for details

Quality Control

Our Erlotinib Hydrochloride is manufactured under strict quality management systems. We provide material that meets high-purity standards suitable for pharmaceutical development and manufacturing. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles. Certificates of Analysis (COA) are available upon request.

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 dry 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%
Water Content (KF)	≤0.5%
Residue on Ignition	≤0.1%
Heavy Metals	≤20 ppm
Related Substances (HPLC)	Individual impurity ≤0.5%; Total impurities ≤1.0%

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