Description

Lapatinib Impurity 4 CAS NO 2172855-57-9 is a high-purity chemical reference standard used for the analytical profiling and quality control of the active pharmaceutical ingredient (API) Lapatinib. This impurity is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance. It is primarily utilized in research and development, method validation, and stability studies within the pharmaceutical and biotechnology sectors.

Application

• Pharmaceutical Impurity Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Lapatinib drug substance and finished products.
• Analytical Method Development & Validation: Essential for developing, qualifying, and validating HPLC, UPLC, and LC-MS methods in quality control laboratories.
• Stability and Forced Degradation Studies: Employed to monitor impurity profiles and understand degradation pathways of Lapatinib under various stress conditions.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Pharmaceutical Research: Serves as a key intermediate or related substance in ongoing research to understand the metabolism and pharmacokinetics of Lapatinib.
• Quality Assurance/Quality Control (QA/QC): Used for routine batch release testing to ensure Lapatinib API meets stringent pharmacopeial (USP, EP) specifications.

Basic Information

Item	Details
Product Name	Lapatinib Impurity 4
CAS No.	2172855-57-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lapatinib Related Compound 4; Lapatinib Impurity D; Lapatinib EP Impurity D; Lapatinib USP Impurity; Tykerb Impurity 4; N-[3-Chloro-4-[(3-fluorophenyl)methoxy]phenyl]-6-[5-[(2-methylsulfonylethylamino)methyl]-2-furyl]quinazolin-4-amine (proposed); Lapatinib Specified Impurity
EINECS	Contact for details

Quality Control

Our Lapatinib Impurity 4 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, MS, NMR). We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results and confirming compliance with in-house specifications. Our quality commitment ensures the material is suitable for its intended use in regulatory and analytical applications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider storing under an inert atmosphere.

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)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.