Description

Olmutinib is a highly selective, third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor. This compound is of significant commercial and therapeutic importance for its targeted action against specific EGFR mutations, including T790M, which are associated with resistance to earlier-generation therapies. It is primarily required by pharmaceutical manufacturers, research institutions, and clinical laboratories engaged in the development and production of advanced oncology treatments.

Application

• Pharmaceutical Active Ingredient (API): Core component in the formulation of targeted cancer therapeutics for non-small cell lung cancer (NSCLC).
• Biomedical Research: Critical reference standard and tool compound for studying EGFR mutation biology, drug resistance mechanisms, and signal transduction pathways.
• Preclinical Development: Used in pharmacokinetic, pharmacodynamic, and toxicology studies to support Investigational New Drug (IND) applications.
• Analytical Testing: Serves as a high-purity calibration standard for quality control and assay development in pharmaceutical analytics.

Basic Information

Product Name	Olmutinib
CAS No.	1353550-13-6
Molecular Formula	C₂₇H₃₄N₆O₂
Molecular Weight	474.60 g/mol
Synonyms	Olmutinib; HM61713; BI 1482694; (R,E)-N-(2-(2-(Dimethylamino)ethyl)-4-(4-fluoro-2-methyl-1H-indol-5-yloxy)pyrimidin-5-yl)-4-methoxy-7-(4-methylpiperazin-1-yl)quinoline-3-carboxamide; 5-Pyrimidinamine, N-[2-[2-(dimethylamino)ethyl]-4-[(4-fluoro-2-methyl-1H-indol-5-yl)oxy]-5-pyrimidinyl]-4-methoxy-7-(4-methyl-1-piperazinyl)-3-quinolinecarboxamide, (αR)-
EINECS	Contact for details

Quality Control

Our Olmutinib is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identity confirmation by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and stringent control of related substances and residual solvents. Certificates of Analysis (COA) documenting compliance with in-house specifications are available upon request.

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 product is hygroscopic (moisture-sensitive) and should be handled under dry conditions to maintain stability and potency.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥98.5%
Related Substances (HPLC)	Total impurities ≤1.5% Any single unknown impurity ≤0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤0.5%
Heavy Metals	≤20 ppm

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