Description

Neratinib Pyridine n-Oxide (M3) is a key pharmaceutical intermediate and metabolite in the synthesis and study of the tyrosine kinase inhibitor Neratinib. This compound is of critical importance for research and development activities focused on oncology therapeutics, particularly for the treatment of HER2-positive breast cancer. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and manufacturers engaged in the development, scale-up, and quality control of advanced active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Intermediate: A crucial building block in the synthetic pathway for the production of the anticancer drug Neratinib.
• Metabolite Reference Standard: Used as an analytical standard in bioanalytical studies to identify and quantify Neratinib metabolites during pharmacokinetic and pharmacodynamic research.
• Process Chemistry & Impurity Profiling: Essential for studying and controlling process-related impurities during API manufacturing to ensure final product purity and regulatory compliance.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Employed in in vitro and in vivo studies to understand the metabolic fate and stability of Neratinib.
• Quality Control & Analytical Development: Serves as a certified reference material (CRM) for method development and validation in HPLC, LC-MS, and other analytical techniques.
• Preclinical Research: Used in laboratory investigations to elucidate the mechanism of action and metabolic pathways of tyrosine kinase inhibitors.

Basic Information

Product Name	Neratinib Pyridine n-Oxide (M3)
CAS No.	1376619-94-1
Molecular Formula	C30H29ClFN5O4
Molecular Weight	577.03 g/mol
Synonyms	Neratinib N-Oxide; Neratinib Metabolite M3; 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 1-Oxide; UNII-6B3I4P8Q4F; 6B3I4P8Q4F; Neratinib Pyridine N-Oxide Impurity
EINECS	Contact for details

Quality Control

Our Neratinib Pyridine n-Oxide (M3) is manufactured under strict quality systems to ensure high purity and batch-to-batch consistency suitable for pharmaceutical research and development. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. A detailed Certificate of Analysis (COA) is provided, documenting all critical quality attributes to support regulatory filings and GLP/GMP compliance.

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) and should be handled under dry conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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