Description

Osimertinib Dimesylate is a high-purity, small-molecule active pharmaceutical ingredient (API) and a key intermediate in advanced pharmaceutical manufacturing. This compound is the dimesylate salt form of Osimertinib, a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, offering enhanced stability and handling properties for precise formulation. It is critically required by pharmaceutical R&D laboratories, contract development and manufacturing organizations (CDMOs), and API producers engaged in the development and production of targeted oncology therapeutics.

Application

• Pharmaceutical API Synthesis: Primary use as the active pharmaceutical ingredient in the manufacture of targeted cancer therapies.
• Oncology Drug Development: Critical raw material in R&D for developing next-generation EGFR tyrosine kinase inhibitors.
• Reference Standard: Serves as a high-purity chemical reference standard for analytical method development and quality control testing.
• Preclinical & Clinical Research: Used in formulation studies and the production of drug products for preclinical and clinical trial batches.
• Process Chemistry & Scale-Up: Key intermediate for process optimization and scale-up activities in pilot plants and commercial manufacturing.

Basic Information

Product Name	Osimertinib Dimesylate
CAS No.	2070014-82-1
Molecular Formula	C₂₈H₃₃N₇O₂ • 2CH₄O₃S
Molecular Weight	679.8 g/mol
Synonyms	AZD-9291 Dimesylate; Tagrisso Dimesylate; 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 dimesylate; Osimertinib bis(methanesulfonate); (E)-N-(2-(2-(Dimethylamino)ethyl-methylamino)-4-methoxy-5-((4-(1-methyl-1H-indol-3-yl)pyrimidin-2-yl)amino)phenyl)acrylamide dimesylate
EINECS	Contact for details

Quality Control

Our Osimertinib Dimesylate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, residual solvent analysis, and identification by spectroscopic methods, to ensure it meets stringent specifications for pharmaceutical use. A Certificate of Analysis (COA) detailing all test results is provided with every shipment to guarantee traceability, consistency, and compliance with cGMP guidelines where applicable.

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 material is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability and potency.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Assay (HPLC)	≥98.0%
Related Substances (HPLC)	Total impurities ≤2.0%
Water Content (KF)	≤1.0%
Residual Solvents (GC)	Meets ICH Q3C guidelines
Heavy Metals	≤20 ppm

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