Description

Dacomitinib Impurity Sfxj is a designated impurity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Dacomitinib. This high-purity compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance. It is primarily utilized in method development, validation, and routine batch testing within the pharmaceutical research and development sector.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Dacomitinib API.
• Analytical Method Development: Used to establish and validate HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance: Essential for monitoring and controlling impurity levels in Dacomitinib drug substance and drug product batches to meet ICH guidelines.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing characterized impurity data for drug master files.
• Stability Studies: Employed to identify and track degradation products formed under various stress conditions.
• Research & Development: Used in process chemistry to understand and optimize synthesis pathways to minimize impurity formation.

Basic Information

Product Name	Dacomitinib Impurity Sfxj
CAS No.	2119689-75-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	PF-00299804 Impurity Sfxj; Dacomitinib Related Compound Sfxj; (2E)-N-{4-[(3-Chloro-4-fluorophenyl)amino]-7-methoxy-6-quinazolinyl}-4-(piperidin-1-yl)but-2-enamide Impurity; VIZIMPRO Impurity Sfxj; Dacomitinib Specified Impurity; Dacomitinib Process Impurity
EINECS	Contact for details

Quality Control

Our Dacomitinib Impurity Sfxj is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical characterization using advanced techniques such as HPLC, LC-MS, NMR, and IR to confirm identity and purity. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing all test results against established specifications. Our quality commitment ensures compliance with the stringent requirements of ICH Q3A(R2) and Q3B(R2) guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. For long-term storage, consider storing at 2-8°C. The container should be kept sealed to protect the material from moisture.

Specification

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