Description

Osimertinib Impurity M CAS NO 1975982-94-5 is a specified impurity and degradation product associated with the active pharmaceutical ingredient Osimertinib, a third-generation EGFR tyrosine kinase inhibitor. This compound is critical for pharmaceutical research, development, and quality control, ensuring the safety and efficacy of the final drug product. It is primarily required by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies for method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Osimertinib drug substance and drug products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor and control impurity levels in accordance with ICH guidelines.
• Stability Studies: Employed to identify and quantify degradation products formed under various stress conditions (e.g., heat, light, humidity) during drug stability testing.
• Quality Control & Batch Release: Serves as a system suitability and identification standard in the routine QC testing of Osimertinib to ensure compliance with regulatory specifications.
• Regulatory Submissions: Provides necessary data on impurity identity and qualification for regulatory filings (e.g., FDA, EMA) to support drug approval.
• Research on Degradation Pathways: Used in research settings to study the chemical degradation mechanisms of Osimertinib.

Basic Information

Product Name	Osimertinib Impurity M
CAS No.	1975982-94-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Osimertinib Related Compound M; AZD9291 Impurity M; N-[2-[[2-(Dimethylamino)ethyl]methylamino]-4-methoxy-5-[[4-(1-methylindol-3-yl)pyrimidin-2-yl]amino]phenyl]prop-2-enamide; (E)-N-(2-((2-(Dimethylamino)ethyl)(methyl)amino)-4-methoxy-5-((4-(1-methyl-1H-indol-3-yl)pyrimidin-2-yl)amino)phenyl)acrylamide; Tagrisso Impurity M
EINECS	Contact for details

Quality Control

Our Osimertinib Impurity M is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided, detailing batch-specific results for purity, assay, and impurity profile. Our quality commitment aligns with the principles of GMP/GLP and relevant ICH guidelines.

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); ensure the container is sealed tightly after each use to minimize exposure to atmospheric humidity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Assay	≥ 98.0% (on dried basis)
Water Content (KF)	≤ 1.0%
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.