Description

Dacomitinib Impurity C is a specified organic impurity used as a critical reference standard in the pharmaceutical development and quality control of Dacomitinib, a targeted cancer therapy. This compound is essential for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API) by enabling accurate identification and quantification of process-related impurities. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the synthesis, purification, and batch release of Dacomitinib.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for calibrating analytical instruments and validating testing methods in accordance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Method Development and Validation: Used in the development and validation of High-Performance Liquid Chromatography (HPLC) and Ultra-High-Performance Liquid Chromatography (UHPLC) methods for impurity profiling.
• Quality Control and Batch Release: Critical for the routine analysis of Dacomitinib API batches to monitor and control impurity levels, ensuring they remain within specified safety thresholds.
• Stability Studies: Employed in forced degradation and long-term stability studies to identify and track impurity formation under various stress conditions.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs) to demonstrate comprehensive impurity control.
• Process Chemistry Research: Aids chemists in optimizing synthesis and purification pathways to minimize the formation of this specific impurity during API manufacturing.

Basic Information

Product Name	Dacomitinib Impurity C
CAS No.	869199-69-9
Molecular Formula	C24H25ClFN5O2
Molecular Weight	477.94 g/mol
Synonyms	PF-00299804 Impurity C; (2E)-N-{4-[(3-Chloro-4-fluorophenyl)amino]-7-methoxy-6-quinolinyl}-4-(dimethylamino)-2-butenamide; Dacomitinib Related Compound C; Dacomitinib EP Impurity C; Dacomitinib USP Impurity C; Dacomitinib Process Impurity C; VIZIMPRO Impurity C
EINECS	Contact for details

Quality Control

Every batch of Dacomitinib Impurity C is manufactured under a quality management system and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our standard grade meets the requirements for use as a pharmaceutical reference standard. Comprehensive testing includes identification by spectroscopic methods, purity determination by HPLC, and control of residual solvents and moisture. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. The material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 0.5% w/w
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.