Description

Neratinib Impurity 12 CAS NO 544417-27-8 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Neratinib, a tyrosine kinase inhibitor. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in drug development, quality control (QC), and stability studies.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Neratinib Impurity 12 in drug substance and finished product analysis.
• Method Development and Validation: Essential for developing and validating robust analytical methods, such as HPLC and LC-MS, for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor impurity levels and ensure compliance with ICH guidelines and regulatory specifications (e.g., FDA, EMA).
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions to determine drug shelf life.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research and Development: Supports synthetic chemistry research aimed at understanding degradation pathways and improving the synthesis of Neratinib.

Basic Information

Product Name	Neratinib Impurity 12
CAS No.	544417-27-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Neratinib Related Compound 12; Neratinib EP Impurity 12; Neratinib USP Impurity 12; HKI-272 Impurity 12; (2E)-N-[4-[[3-Chloro-4-[(pyridin-2-yl)methoxy]phenyl]amino]-3-cyano-7-ethoxyquinolin-6-yl]-4-(dimethylamino)but-2-enamide; UNII-8J3F4O66UJ; 8J3F4O66UJ
EINECS	Contact for details

Quality Control

Our Neratinib Impurity 12 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant specifications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the product label or COA. Keep the container in a dry, cool, and well-ventilated place. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
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.