Description

Osimertinib Impurity C is a specified impurity of the active pharmaceutical ingredient (API) Osimertinib, a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor. This impurity is a critical reference standard used in the pharmaceutical development and quality control processes to ensure the purity, safety, and efficacy of the final drug product. It is essential for analytical chemists and quality assurance professionals in pharmaceutical R&D and manufacturing who require high-purity chemical reference materials for method validation and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Osimertinib Impurity C in drug substance and drug product testing.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating HPLC/UPLC methods for Osimertinib API and its formulations.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor impurity profiles and ensure compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Supports the preparation of Chemistry, Manufacturing, and Controls (CMC) documentation for regulatory filings with agencies like the FDA, EMA, and PMDA.
• Stability Studies: Employed as a marker to track degradation pathways and establish the shelf-life of Osimertinib-based drug products.
• Process Chemistry Research: Aids in understanding and optimizing the synthesis and purification processes of Osimertinib to minimize this specific impurity.

Basic Information

Product Name	Osimertinib Impurity C
CAS No.	2227103-37-7
Molecular Formula	C28H33N7O2
Molecular Weight	499.61 g/mol
Synonyms	N-[2-[[2-(Dimethylamino)ethyl]methylamino]-4-methoxy-5-[[4-(1-methylindol-3-yl)pyrimidin-2-yl]amino]phenyl]prop-2-enamide; AZD9291 Impurity C; Osimertinib Related Compound C; Tagrisso Impurity C; (E)-N-(2-((2-(Dimethylamino)ethyl)(methyl)amino)-4-methoxy-5-((4-(1-methyl-1H-indol-3-yl)pyrimidin-2-yl)amino)phenyl)acrylamide; UNII-5J0K2B3Q6I
EINECS	Contact for details

Quality Control

Every batch of Osimertinib Impurity C is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming conformity to client specifications.

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 compound is hygroscopic (moisture-sensitive) and should be handled in a dry 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 matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.