Description

Dacomitinib Impurity Dfaj is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Dacomitinib. This high-purity reference material is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance. It is primarily utilized in research and development, method validation, and stability studies for this targeted oncology therapeutic.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Dacomitinib API.
• Method Development & Validation (HPLC/LC-MS): Essential for developing and validating chromatographic methods to monitor and control impurity levels.
• Stability Indicating Studies: Used to identify and quantify degradation products formed under various stress conditions (e.g., heat, light, humidity).
• Quality Control & Batch Release: A critical component in the QC testing of Dacomitinib drug substance and drug product to meet ICH guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing impurity characterization data for health authorities like the FDA and EMA.
• Research on Degradation Pathways: Aids in understanding the chemical stability and degradation mechanisms of the parent drug molecule.

Basic Information

Product Name	Dacomitinib Impurity Dfaj
CAS No.	1562180-31-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dacomitinib Related Compound Dfaj; Dacomitinib Impurity 4; PF-00299804 Impurity Dfaj; (2E)-N-[4-[(3-Chloro-4-fluorophenyl)amino]-7-methoxy-6-quinazolinyl]-4-(piperidin-1-yl)but-2-enamide; PF-00299804 Degradant; Dacomitinib Process Impurity; Dacomitinib Degradation Product
EINECS	Contact for details

Quality Control

Our Dacomitinib Impurity Dfaj is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical characterization using advanced techniques such as HPLC, LC-MS, and NMR to confirm identity and purity. A detailed Certificate of Analysis (COA) is provided, containing batch-specific data that meets the stringent requirements for pharmaceutical reference standards. Our quality commitment ensures reliability for your critical analytical and regulatory applications.

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 Certificate of Analysis. Keep the container in a dry, well-ventilated place. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Complies with individual and total limits
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 2.0%

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