Description

Lapatinib Impurity 10 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient Lapatinib, a tyrosine kinase inhibitor. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control processes. The availability of well-characterized impurities like this is essential for compliance with stringent global pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quality control and release testing of Lapatinib drug substance and finished products.
• Analytical Method Development: Used in HPLC, UPLC, and LC-MS methods to identify, quantify, and characterize impurities during drug development.
• Regulatory Compliance & Filings: Essential for preparing regulatory documentation (e.g., for FDA, EMA) to establish impurity profiles and justify specification limits.
• Stability Studies: Employed to monitor the formation and levels of this specific degradation product under various stress conditions.
• Research & Development: Used in academic and industrial R&D to study the degradation pathways and metabolism of Lapatinib.
• Pharmacopeial Testing: Applied as a system suitability and identification standard in testing aligned with USP, EP, or ICH guidelines.

Basic Information

Product Name	Lapatinib Impurity 10
CAS No.	1152131-73-1
Molecular Formula	C29H26ClFN4O4S
Molecular Weight	581.06 g/mol
Synonyms	Lapatinib Related Compound 10; Lapatinib EP Impurity J; Lapatinib USP Impurity; N-[3-Chloro-4-[(3-fluorophenyl)methoxy]phenyl]-6-[5-[(2-methylsulfonylethylamino)methyl]-2-furyl]quinazolin-4-amine; Lapatinib Desmethyl Impurity; Tykerb Impurity 10; GW572016 Impurity 10
EINECS	Contact for details

Quality Control

Every batch of Lapatinib Impurity 10 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical characterization using techniques such as HPLC, LC-MS, NMR, and IR to ensure identity, purity, and conformity with client specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A/B, USP, and EP guidelines for impurities in new drug substances.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. Keep the container tightly sealed in a cool, dry, and well-ventilated place.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
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.