Description

Dacomitinib Impurity D is a designated impurity of the active pharmaceutical ingredient Dacomitinib, a tyrosine kinase inhibitor used in targeted cancer therapy. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is essential for manufacturers, analytical laboratories, and regulatory bodies focused on ensuring the purity, safety, and efficacy of the final drug product.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Dacomitinib drug substance and finished products.
• Analytical Method Development: Crucial for developing and optimizing chromatographic methods (HPLC, UPLC) to separate and detect process-related impurities.
• Quality Control & Assurance: Used in routine batch testing to monitor impurity profiles and ensure compliance with ICH Q3A/B guidelines and regulatory specifications.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions to establish product shelf-life.
• Regulatory Submissions: Supports the filing of regulatory documents (e.g., CMC sections for FDA, EMA) by providing impurity characterization data.
• Process Chemistry Research: Aids in understanding and optimizing the synthesis pathway of Dacomitinib to minimize the formation of this specific impurity.

Basic Information

Product Name	Dacomitinib Impurity D
CAS No.	869199-67-7
Molecular Formula	C24H25ClFN5O2
Molecular Weight	477.94 g/mol
Synonyms	PF-00299804 Impurity D; (2E)-N-{4-[(3-Chloro-4-fluorophenyl)amino]-7-methoxy-6-quinolinyl}-4-(piperidin-1-yl)-2-butenamide; Dacomitinib Related Compound D; Dacomitinib EP Impurity D; Dacomitinib USP Impurity D; Vizimpro Impurity D; PF-00299804 Related Substance D
EINECS	Contact for details

Quality Control

Our Dacomitinib Impurity D is manufactured under strict quality systems. Each batch is characterized and tested using advanced analytical techniques to ensure identity, purity, and consistency. We provide comprehensive Certificates of Analysis (COA) containing data from HPLC, NMR, and MS, ensuring compliance with pharmacopeial standards (USP/EP) and ICH guidelines for impurity standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C, in a dry environment. For long-term storage, consider storing at 2-8°C. The compound is light-sensitive (store away from light) and hygroscopic (moisture-sensitive).

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 ≤ 5.0%
Water Content (KF)	≤ 5.0%
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.