Description

Lapatinib Impurity 8 is a specified impurity and degradation product of 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 analytical method development, validation, and quality control processes. It is essential for manufacturers, contract research organizations (CROs), and regulatory bodies focused on ensuring the purity, safety, and efficacy of Lapatinib-based drug products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Lapatinib drug substance and finished products.
• Analytical Method Development: Crucial for developing and optimizing chromatographic methods (HPLC, UPLC) to separate and analyze impurities.
• Quality Control & Assurance: Used in routine QC testing to monitor impurity profiles and ensure batch-to-batch consistency and compliance with ICH guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions to establish product shelf life.
• Process Chemistry Research: Aids in understanding the formation pathways of this impurity during the synthesis of Lapatinib, helping to optimize manufacturing processes.

Basic Information

Product Name	Lapatinib Impurity 8
CAS No.	320337-48-2
Molecular Formula	C29H26ClFN4O4S
Molecular Weight	581.06 g/mol
Synonyms	N-[3-Chloro-4-[(3-fluorophenyl)methoxy]phenyl]-6-[5-[(2-methylsulfonylethylamino)methyl]-2-furyl]quinazolin-4-amine; Lapatinib Related Compound 8; Lapatinib EP Impurity I; Lapatinib USP Impurity; GW572016 Impurity 8; Tykerb Impurity 8; Tyverb Impurity 8
EINECS	Contact for details

Quality Control

Our Lapatinib Impurity 8 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing all test results against established specifications. Our quality standards align with ICH Q3A(R2) and Q3B(R2) guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The product is light-sensitive and should be handled under appropriate conditions to prevent degradation. Keep the container in a dry, cool, and well-ventilated area.

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)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
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.