Description

Osimertinib Impurity 7 CAS NO 1825287-91-9 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, specifically in the development and manufacturing of the targeted cancer therapy Osimertinib. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug purity, safety, and efficacy. The availability of this well-characterized impurity standard is essential for method validation, stability studies, and meeting stringent regulatory compliance.

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 & Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Quality Control & Assurance (QC/QA): A critical component in routine batch release testing to monitor and control impurity levels, ensuring compliance with ICH guidelines.
• Stability Studies: Employed to track the formation and growth of this specific degradation product under various stress conditions.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough understanding and control of the drug's impurity profile.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the degradation pathways of Osimertinib.

Basic Information

Product Name	Osimertinib Impurity 7
CAS No.	1825287-91-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Osimertinib Related Compound 7; AZD9291 Impurity 7; N-[2-[[2-(Dimethylamino)ethyl]methylamino]-4-methoxy-5-[[4-(1-methylindol-3-yl)pyrimidin-2-yl]amino]phenyl]prop-2-enamide; Tagrisso Impurity 7; (E)-N-(2-((2-(Dimethylamino)ethyl)(methyl)amino)-4-methoxy-5-((4-(1-methyl-1H-indol-3-yl)pyrimidin-2-yl)amino)phenyl)acrylamide; Osimertinib EP Impurity G; Osimertinib USP Impurity
EINECS	Contact for details

Quality Control

Our Osimertinib Impurity 7 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity determination, spectroscopic identification (NMR, MS, IR), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data and batch-specific results are provided to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a desiccated environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 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.