Description

Dacomitinib Impurity Wyh is a designated impurity of the tyrosine kinase inhibitor Dacomitinib, a critical reference standard in pharmaceutical development and quality control. This compound is essential for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) by serving as a benchmark for analytical method validation and impurity profiling. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the research, production, and quality assurance of Dacomitinib-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Dacomitinib.
• Analytical Method Development: Critical for developing and validating HPLC, UPLC, and LC-MS methods to detect and quantify this specific impurity.
• Impurity Profiling and Identification: Serves as a key marker in stability studies and batch release testing to monitor impurity levels according to ICH guidelines.
• Quality Control & Assurance: Employed in routine QC testing of Dacomitinib API and finished drug products to ensure compliance with regulatory specifications.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research and Development: Used in synthetic chemistry research to study degradation pathways and to optimize purification processes for the API.

Basic Information

Product Name	Dacomitinib Impurity Wyh
CAS No.	2190490-31-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dacomitinib Related Compound Wyh; Dacomitinib Impurity; PF-00299804 Impurity Wyh; (2E)-N-[4-[(3-Chloro-4-fluorophenyl)amino]-7-methoxy-6-quinazolinyl]-4-(piperidin-1-yl)but-2-enamide; UNII-9F8H8W792V; Dacomitinib EP Impurity Wyh; Dacomitinib USP Impurity Wyh
EINECS	Contact for details

Quality Control

Our Dacomitinib Impurity Wyh is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural elucidation via spectroscopic methods (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided and traceable to primary standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material should be kept in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C

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