Description

Lapatinib-D4 is a deuterated isotopologue of the tyrosine kinase inhibitor Lapatinib, specifically labeled with four deuterium atoms. This stable isotope-labeled compound is a critical reference standard and internal standard for the precise quantification and pharmacokinetic studies of Lapatinib in complex biological matrices using advanced analytical techniques like LC-MS/MS. It is essential for pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical service providers engaged in drug metabolism, bioanalytical method development, and ensuring regulatory compliance in drug development.

Application

• Bioanalytical Reference Standard: Serves as a primary standard for the calibration and validation of quantitative LC-MS/MS methods for Lapatinib in plasma, serum, and tissue samples.
• Pharmacokinetic & Metabolism Studies: Used as a stable isotope-labeled internal standard to ensure accuracy and precision in measuring drug concentration-time profiles, bioavailability, and metabolic stability.
• Drug Impurity Profiling: Employed in method development to identify and quantify potential deuterated impurities or metabolites in active pharmaceutical ingredient (API) batches.
• Clinical Research Support: Critical for reliable data generation in clinical trials involving Lapatinib, supporting submissions to regulatory bodies like the FDA and EMA.
• DMPK (Drug Metabolism and Pharmacokinetics): Facilitates high-throughput screening and definitive studies on absorption, distribution, metabolism, and excretion (ADME) properties.
• Quality Control in Manufacturing: Supports in-house QC laboratories in pharmaceutical companies to maintain stringent quality standards for Lapatinib API and finished dosage forms.

Basic Information

Product Name	Lapatinib-D4
CAS No.	1184263-99-7
Molecular Formula	C29H22D4ClFN4O4S
Molecular Weight	581.09 g/mol (approximate)
Synonyms	N-[3-Chloro-4-[(3-fluorophenyl)methoxy]phenyl]-6-[5-[(2-methylsulfonylethylamino)methyl]-2-furyl]quinazolin-4-amine-d4; GW572016-D4; Tykerb-D4; Tyverb-D4; Lapatinib (phenyl-d4); Lapatinib-d4 (phenyl ring deuterated)
EINECS	Contact for details

Quality Control

Every batch of Lapatinib-D4 is manufactured and analyzed under strict quality management systems. We provide comprehensive Certificates of Analysis (COA) that detail critical parameters including isotopic purity (D-enrichment), chemical purity, and identity confirmation. Our quality protocols are designed to meet the exacting standards required for pharmaceutical reference materials, supporting GMP/GLP-compliant research and development.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a freezer. This product is hygroscopic (moisture-sensitive). Allow the vial to equilibrate to room temperature in a desiccator before opening to minimize moisture uptake.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (H-NMR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥98.0%
Isotopic Purity (D-enrichment)	≥98 atom % D
Water Content (KF)	≤1.0%
Residual Solvents (GC)	Complies with ICH guidelines

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