Description

Lapatinib 2-Fluoro Impurity is a key chemical reference standard used in the pharmaceutical development and quality control of the anticancer drug Lapatinib. This impurity is critical for ensuring the safety and efficacy of the final drug product by enabling accurate identification and quantification during analytical testing. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories involved in method development, stability studies, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the calibration of analytical instruments (HPLC, LC-MS) in drug substance and product testing.
• Method Development and Validation: Essential for developing and validating stability-indicating analytical methods to monitor impurity profiles in Lapatinib API and formulations.
• Quality Control (QC) Testing: Used in routine QC laboratories to quantify the 2-fluoro impurity against established specifications to ensure batch-to-batch consistency.
• Regulatory Compliance and Filing: Critical for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Stability Studies: Employed to track the formation and levels of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Research and Development: Used in R&D to understand the synthesis pathway, degradation mechanisms, and to improve the purification process of Lapatinib.

Basic Information

Product Name	Lapatinib 2-Fluoro Impurity
CAS No.	1393112-45-2
Molecular Formula	C29H26F2N4O4S
Molecular Weight	580.61 g/mol
Synonyms	Lapatinib Fluorinated Impurity; Lapatinib Related Compound F; 2-Fluoro Lapatinib Impurity; N-[3-Chloro-4-[(3-fluorophenyl)methoxy]phenyl]-6-[5-[[[2-(methylsulfonyl)ethyl]amino]methyl]-2-furyl]-4-quinazolinamine; Lapatinib EP Impurity F; Lapatinib USP Impurity F; Tykerb/Tyverb Impurity (2-Fluoro)
EINECS	Contact for details

Quality Control

Our Lapatinib 2-Fluoro Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis to ensure compliance with ICH Q3A/B guidelines and other relevant pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing all test results and specifications is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive (store away from light).

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)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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