Description

Neratinib Impurity CAS NO 1348481-03-7 is a high-purity chemical reference standard used in the pharmaceutical development and quality control processes. This compound is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient (API) Neratinib by accurately identifying and quantifying related substances. It is an essential tool for analytical chemists and quality assurance professionals working in pharmaceutical R&D and manufacturing. The precise characterization of such impurities is fundamental to meeting stringent global regulatory requirements for drug approval and batch release.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Neratinib-related impurities in drug substance and drug product analysis.
• Method Development and Validation: Critical for developing and validating robust analytical methods, such as HPLC and LC-MS, for impurity profiling.
• Quality Control (QC) Testing: Used in routine QC laboratories to monitor impurity levels against established specifications, ensuring batch-to-batch consistency and compliance.
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation of this specific impurity over time and under various stress conditions.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive understanding and control of the drug's impurity profile.
• Process Chemistry Research: Aids chemists in optimizing synthesis and purification processes to minimize the formation of this impurity during API manufacturing.

Basic Information

Item	Detail
Product Name	Neratinib Impurity
CAS No.	1348481-03-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Neratinib Related Compound; Neratinib Specified Impurity; HKI-272 Impurity; (2E)-N-[4-[[3-Chloro-4-[(pyridin-2-yl)methoxy]phenyl]amino]-3-cyano-7-ethoxyquinolin-6-yl]-4-(dimethylamino)but-2-enamide; Tykerb/Tyverb Impurity; PF-05208767 Impurity; 6-Quinolinecarboxamide, N-[4-[[3-chloro-4-[(2-pyridinylmethyl)oxy]phenyl]amino]-3-cyano-7-ethoxy-6-quinolinyl]-4-(dimethylamino)-2-butenamide, (2E)-
EINECS	Contact for details

Quality Control

Every batch of Neratinib Impurity CAS NO 1348481-03-7 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing using advanced chromatographic and spectroscopic techniques to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for all critical quality attributes. Our quality standards align with ICH guidelines and support cGMP compliance for use in pharmaceutical applications.

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 in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
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.