Description

Osimertinib Mesylate CAS NO 1421373-66-1 is the mesylate salt form of osimertinib, a potent and selective third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor. This compound is a critical active pharmaceutical ingredient (API) specifically designed to target EGFR T790M mutation-positive non-small cell lung cancer (NSCLC). It is essential for pharmaceutical manufacturers and research institutions engaged in the development and production of targeted oncology therapeutics.

Application

• Primary Active Pharmaceutical Ingredient (API): Core component in the commercial formulation of targeted lung cancer medications.
• Oncological Research & Development: Critical reference standard and building block for discovering new EGFR inhibitor derivatives and combination therapies.
• Pharmaceutical Intermediates: Used in the synthesis of final drug products and dosage forms such as tablets.
• Bioanalytical & Pharmacokinetic Studies: Serves as a standard for method development and validation in drug metabolism and bioequivalence studies.
• Preclinical & Clinical Trial Material: Supplies material for toxicity studies, efficacy testing, and clinical trial batches.
• Academic Research: Used in university and institutional labs studying cancer biology, drug resistance mechanisms, and signal transduction pathways.

Basic Information

Product Name	Osimertinib Mesylate
CAS No.	1421373-66-1
Molecular Formula	C28H33N7O2 • CH4O3S
Molecular Weight	595.71 g/mol
Synonyms	AZD9291 Mesylate; Osimertinib Methanesulfonate; N-(2-{[2-(Dimethylamino)ethyl](methyl)amino}-4-methoxy-5-{[4-(1-methyl-1H-indol-3-yl)pyrimidin-2-yl]amino}phenyl)prop-2-enamide methanesulfonate; Tagrisso™ (Brand Name) Mesylate Salt; Mereletinib Mesylate
EINECS	Contact for details

Quality Control

Our Osimertinib Mesylate is manufactured under strict quality management systems. We provide material that meets high-purity standards suitable for pharmaceutical R&D and API production. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles. Specifications can be aligned with client requirements for preclinical through commercial applications.

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 under inert conditions or in a desiccator to maintain stability and potency.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Assay (HPLC)	≥98.0%
Related Substances (HPLC)	Total impurities: ≤2.0% Any single impurity: ≤0.5%
Water Content (KF)	≤1.0%
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.