Description

Dacomitinib Impurity 2F3Lxj is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, specifically in the development and manufacturing of the oncology drug Dacomitinib. It is primarily required by pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and contract research organizations (CROs) to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Dacomitinib active pharmaceutical ingredient (API) and finished drug products.
• Method Development & Validation: Essential for developing and validating robust analytical methods, such as HPLC and LC-MS, for impurity profiling.
• Quality Control & Assurance: Used in routine batch release testing to monitor and control impurity levels, ensuring compliance with ICH guidelines and regulatory filings.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions and throughout the drug's shelf life.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Supports process chemistry research to understand impurity formation pathways and optimize synthesis routes for cleaner API production.

Basic Information

Product Name	Dacomitinib Impurity 2F3Lxj
CAS No.	1454307-45-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	PF-00299804 Impurity 2F3Lxj; Dacomitinib Related Compound 2F3Lxj; (2E)-N-[4-[(3-Chloro-4-fluorophenyl)amino]-7-methoxy-6-quinazolinyl]-4-(piperidin-1-yl)but-2-enamide (proposed); VIZIMPRO Impurity; UNII-2F3Lxj; Dacomitinib Process Impurity; Dacomitinib Degradant
EINECS	Contact for details

Quality Control

Every batch of Dacomitinib Impurity 2F3Lxj is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including identity confirmation by spectroscopic methods (IR, NMR, MS) and purity assessment by chromatographic techniques (HPLC, LC-MS). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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