Description

Lapatinib 4-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, quantification, and control of related substances during manufacturing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and compliance with stringent ICH guidelines.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Lapatinib drug substance and drug products.
• Method Development and Validation: Essential for developing and validating robust analytical methods (e.g., HPLC, UPLC) to monitor impurities in accordance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control (QC) Testing: Used in routine QC laboratories to establish acceptance criteria and ensure batch-to-batch consistency of Lapatinib.
• Stability Studies: Employed to identify and track degradation products formed under various stress conditions (e.g., heat, light, humidity) during drug stability testing.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity profiling and control strategies.
• Research and Development: Utilized in synthetic chemistry R&D to understand impurity formation pathways and optimize purification processes for Lapatinib.

Basic Information

Product Name	Lapatinib 4-Fluoro Impurity
CAS No.	1026818-86-9
Molecular Formula	C29H26ClFN4O4S
Molecular Weight	581.06 g/mol
Synonyms	4-Fluoro Lapatinib Impurity; Lapatinib Fluorinated Impurity; Lapatinib Related Compound 4-F; N-[3-Chloro-4-[(3-fluorophenyl)methoxy]phenyl]-6-[5-[[[2-(methylsulfonyl)ethyl]amino]methyl]-2-furanyl]-4-quinazolinamine; GW572016 4-Fluoro Impurity; Tykerb 4-F Impurity
EINECS	Contact for details

Quality Control

Our Lapatinib 4-Fluoro Impurity is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high-purity standards required for pharmaceutical reference materials. Each batch is characterized using advanced techniques including HPLC, MS, and NMR to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, impurities, and analytical methods, supporting compliance with current Good Manufacturing Practice (cGMP) and relevant ICH guidelines.

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. The material is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 5.0%
Water Content (KF)	≤ 2.0%
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.