Description

Lapatinib Impurity 16 is a specified impurity of Lapatinib, a tyrosine kinase inhibitor used in targeted cancer therapy. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, quality control, and regulatory compliance. It is essential for manufacturers, analytical laboratories, and regulatory bodies involved in the production and validation of high-purity active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Lapatinib API and finished drug products.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, and other chromatographic methods to ensure accurate impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity levels and ensure drug substance purity meets pharmacopeial standards (e.g., USP, EP).
• Regulatory Compliance & Filing: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Used to track the formation of degradation products in Lapatinib formulations under various storage conditions.
• Process Chemistry Research: Aids in understanding and optimizing synthetic pathways to minimize the formation of this specific impurity.

Basic Information

Product Name	Lapatinib Impurity 16
CAS No.	845271-73-0
Molecular Formula	C29H26ClFN4O4S
Molecular Weight	581.06 g/mol
Synonyms	Lapatinib Related Compound 16; Lapatinib EP Impurity G; Lapatinib USP Impurity; N-[3-Chloro-4-[(3-fluorophenyl)methoxy]phenyl]-6-[5-[(2-(methylsulfonyl)ethylamino]methyl]-2-furyl]-4-quinazolinamine; GW572016 Impurity 16; Tykerb Impurity 16; Tyverb Impurity 16
EINECS	Contact for details

Quality Control

Every batch of Lapatinib Impurity 16 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, and residual solvents.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
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)	≤ 1.0%

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