Description

Neratinib Impurity CAS NO 1144516-19-7 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of Neratinib, a targeted cancer therapy. This impurity is critical for ensuring drug safety and efficacy by enabling accurate identification, quantification, and control during the manufacturing process. It is an essential material for analytical laboratories, regulatory affairs, and quality assurance departments within pharmaceutical companies and contract research organizations (CROs).

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material for the identification and structural elucidation of related substances in Neratinib Active Pharmaceutical Ingredient (API).
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity detection.
• Quality Control and Batch Release Testing: Employed in routine QC testing to monitor and control the level of this specific impurity, ensuring compliance with ICH Q3A/B guidelines.
• Regulatory Submissions and Compliance: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to establish impurity acceptance criteria and justify specifications.
• Stability Studies: Used to track the formation or increase of this impurity over time under various stress conditions to determine drug product shelf life.
• Process Chemistry Research & Optimization: Aids chemists in understanding and minimizing the formation of this impurity during the synthesis and purification of Neratinib.

Basic Information

Product Name	Neratinib Impurity
CAS No.	1144516-19-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Neratinib Related Compound; Neratinib Process Impurity; Neratinib Degradant; 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 impurity; Tykerb/Tyverb Impurity; PF-05208767 Impurity; UNII-0J4L35T5Q0 Impurity
EINECS	Contact for details

Quality Control

Our Neratinib Impurity is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced chromatographic and spectroscopic methods, including HPLC, LC-MS, and NMR. We adhere to relevant ICH guidelines and can support compliance needs for cGMP, ISO, and other regulatory frameworks.

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 desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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