Description

Osimertinib Impurity I is a designated impurity of the targeted oncology drug Osimertinib, a third-generation EGFR tyrosine kinase inhibitor. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of the final drug product.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Osimertinib drug substance and finished products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, and LC-MS methods to monitor impurity profiles during drug synthesis and stability studies.
• Quality Control & Assurance: A critical component in routine QC testing to ensure batch-to-batch consistency and compliance with ICH Q3A/B guidelines on impurities.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing impurity characterization data.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity).
• Process Chemistry Research: Used to study and optimize synthetic pathways to minimize the formation of this specific impurity.

Basic Information

Product Name	Osimertinib Impurity I
CAS No.	2044702-55-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Osimertinib Related Compound I; AZD9291 Impurity I; N-[2-[[2-(Dimethylamino)ethyl]methylamino]-4-methoxy-5-[[4-(1-methylindol-3-yl)pyrimidin-2-yl]amino]phenyl]prop-2-enamide; Tagrisso Impurity I; (E)-N-(2-((2-(Dimethylamino)ethyl)(methyl)amino)-4-methoxy-5-((4-(1-methyl-1H-indol-3-yl)pyrimidin-2-yl)amino)phenyl)acrylamide
EINECS	Contact for details

Quality Control

Our Osimertinib Impurity I is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis, to ensure identity, potency, and consistency. We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data, supporting its use as a high-grade reference standard for pharmaceutical applications.

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 must be kept under inert conditions if the container is opened repeatedly to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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