Description

Lapatinib Impurity 2 CAS NO 1807733-95-4 is a high-purity reference standard used for the analytical profiling and quality control of the active pharmaceutical ingredient Lapatinib. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying process-related impurities. It is an essential material for method development, validation, and stability studies in the production of targeted cancer therapies.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quality control (QC) and quality assurance (QA) of Lapatinib active pharmaceutical ingredient (API).
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., FDA, EMA) by providing definitive impurity identification and characterization data for drug master files (DMFs).
• Stability Studies: Used as a marker to monitor the formation and levels of this specific impurity in Lapatinib formulations under various storage conditions.
• Research & Development: Facilitates process chemistry research to understand and minimize the formation of this impurity during API synthesis.
• Pharmacopoeial Testing: Employed in testing to meet the specifications of pharmacopoeias such as USP or EP for Lapatinib and related drug substances.

Basic Information

Product Name	Lapatinib Impurity 2
CAS No.	1807733-95-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lapatinib Related Compound 2; Lapatinib Impurity B; Lapatinib EP Impurity B; Lapatinib USP Impurity; N-[3-Chloro-4-[(3-fluorophenyl)methoxy]phenyl]-6-[5-[(2-methylsulfonylethylamino)methyl]-2-furyl]quinazolin-4-amine; Tykerb Impurity 2; GW572016 Impurity 2
EINECS	Contact for details

Quality Control

Every batch of Lapatinib Impurity 2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, LC-MS, NMR) to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, chromatographic data, and traceability information.

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 Certificate of Analysis. Keep the container in a dry, cool, and well-ventilated place. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
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.