Description

Lapatinib Impurity CAS NO 746591-42-4 is a designated impurity associated with the active pharmaceutical ingredient Lapatinib, a tyrosine kinase inhibitor used in cancer therapy. This compound is critical for pharmaceutical research and development, serving as a key reference standard for method development, validation, and quality control processes. It is primarily required by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies to ensure the purity, safety, and efficacy of Lapatinib drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Lapatinib active pharmaceutical ingredients (APIs) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure compliance with stringent pharmacopeial specifications (e.g., ICH Q3A/B, USP, EP).
• Stability Studies: Used to track the formation and growth of this specific impurity under various stress conditions (thermal, photolytic, hydrolytic) as per ICH guidelines.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Aids in understanding and optimizing synthetic pathways to minimize the formation of this impurity during Lapatinib manufacturing.

Basic Information

Product Name	Lapatinib Impurity
CAS No.	746591-42-4
Molecular Formula	C29H26ClFN4O4S
Molecular Weight	581.06 g/mol
Synonyms	N-[3-Chloro-4-[(3-fluorophenyl)methoxy]phenyl]-6-[5-[(2-(methylsulfonyl)ethylamino]methyl]-2-furanyl]-4-quinazolinamine; Lapatinib Related Compound; Lapatinib Process Impurity; Tykerb Impurity; GW572016 Impurity; Lapatinib Ditosylate Impurity; (E)-N-(3-Chloro-4-((3-fluorobenzyl)oxy)phenyl)-6-(5-((2-(methylsulfonyl)ethylamino)methyl)furan-2-yl)quinazolin-4-amine
EINECS	Contact for details

Quality Control

Our Lapatinib Impurity (CAS 746591-42-4) is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC purity, identity confirmation (IR, MS, NMR), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) containing batch-specific data, traceable to primary standards, is provided with every shipment to support your regulatory and quality requirements.

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 material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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