Description

Neratinib Dimethylamine n-Oxide (M7) is a key pharmaceutical intermediate and metabolite of the tyrosine kinase inhibitor Neratinib. This compound is critical for research and development in the pharmaceutical industry, particularly for analytical method development, impurity profiling, and metabolic studies. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and academic research institutions focused on oncology drug development and quality control.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the quantification and identification of the M7 metabolite in biological matrices and drug formulations.
• Impurity Profiling: Used as a known impurity standard to monitor and control the quality of Neratinib active pharmaceutical ingredient (API) during manufacturing and stability studies.
• Metabolite Research: Essential for in vitro and in vivo pharmacokinetic and pharmacodynamic (PK/PD) studies to understand the metabolism and efficacy of Neratinib.
• Analytical Method Development: A critical component for developing and validating sensitive HPLC, LC-MS, or GC-MS methods for drug analysis.
• Process Chemistry: Used in the development and scale-up of synthetic pathways for Neratinib and related compounds.

Basic Information

Product Name	Neratinib Dimethylamine n-Oxide (M7)
CAS No.	1376615-55-2
Molecular Formula	C30H34N6O4
Molecular Weight	542.63 g/mol
Synonyms	Neratinib N-Oxide; Neratinib Metabolite M7; HKI-272 N-Oxide; (2E)-N-[4-[[3-Chloro-4-[(pyridin-2-yl)methoxy]phenyl]amino]-3-cyano-7-ethoxyquinolin-6-yl]-4-(dimethylamino)but-2-enamide N-Oxide; PF-05208770; UNII-1VK3968V7H
EINECS	Contact for details

Quality Control

Our Neratinib Dimethylamine n-Oxide (M7) is manufactured under strict quality control protocols to ensure high purity and batch-to-batch consistency suitable for pharmaceutical research. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles. We adhere to ICH guidelines for stability and impurity qualification, ensuring the material meets the stringent requirements for use as a reference standard.

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 should be handled under anhydrous conditions to maintain stability. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Single Unknown Impurity (HPLC)	≤ 0.5%
Total Impurities (HPLC)	≤ 2.0%

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