Description

Neratinib Impurity 14 CAS NO 1144516-15-3 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical development and quality control, specifically in the characterization and quantification of impurities in the active pharmaceutical ingredient Neratinib. It is an essential material for analytical chemists, quality assurance professionals, and researchers working in pharmaceutical R&D and manufacturing to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Neratinib Impurity 14 in drug substance and drug product analysis.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch testing in pharmaceutical quality control laboratories to monitor impurity levels.
• Regulatory Compliance & Documentation: Essential for generating impurity data required for regulatory filings (e.g., FDA, EMA) and stability studies.
• Research & Development: Used in studies to understand the formation, fate, and degradation pathways of this specific impurity during API synthesis and formulation.
• Calibration Standard: For calibrating analytical instruments to ensure accurate and precise measurement of this impurity.

Basic Information

Product Name	Neratinib Impurity 14
CAS No.	1144516-15-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Neratinib Related Compound 14; Neratinib EP Impurity 14; Neratinib USP Impurity 14; HKI-272 Impurity 14; (2E)-N-[4-[[3-Chloro-4-[(pyridin-2-yl)methoxy]phenyl]amino]-3-cyano-7-ethoxyquinolin-6-yl]-4-(dimethylamino)but-2-enamide; UNII-Contact for details
EINECS	Contact for details

Quality Control

Our Neratinib Impurity 14 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided, detailing batch-specific results for purity, impurities, and other critical quality attributes. Our quality standards align with ICH guidelines for impurities in new drug substances.

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 in a dry environment. For long-term storage, consider storing under an inert atmosphere to ensure stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unidentified 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.