Description

Lapatinib-D7 Ditosylate CAS NO 1009307-24-7 is a deuterated, ditosylate salt form of the tyrosine kinase inhibitor Lapatinib, specifically designed for use as an internal standard in quantitative bioanalytical studies. This high-purity, isotopically labeled compound is critical for ensuring the accuracy and reliability of pharmacokinetic and metabolism data in drug development. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and academic institutions engaged in advanced LC-MS/MS analysis for oncology research and therapeutic drug monitoring.

Application

• Internal Standard for LC-MS/MS: Serves as a critical, non-interfering reference compound for the precise quantification of Lapatinib and its metabolites in complex biological matrices like plasma, serum, and tissue homogenates.
• Pharmacokinetic (PK) and Pharmacodynamic (PD) Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical research.
• Drug Metabolism Studies: Used to investigate metabolic pathways and identify metabolites, supporting drug safety and efficacy evaluations.
• Bioanalytical Method Development and Validation: Essential for developing robust, sensitive, and specific analytical methods compliant with FDA and EMA guidelines.
• Therapeutic Drug Monitoring (TDM): Facilitates the precise measurement of drug concentrations in patient samples to optimize dosing regimens for personalized cancer therapy.
• Quality Control in Reference Material Production: Acts as a certified reference material (CRM) to ensure the quality and consistency of analytical standards and kits.

Basic Information

Product Name	Lapatinib-D7 Ditosylate
CAS No.	1009307-24-7
Molecular Formula	C₃₄H₂₇D₇ClFN₄O₈S₂
Molecular Weight	~ 761.3 g/mol (Contact for exact value)
Synonyms	Lapatinib Ditosylate-d7; Lapatinib-d7 Ditoluene-4-sulfonate; GW572016-d7 Ditosylate; N-[3-Chloro-4-[(3-fluorophenyl)methoxy]phenyl]-6-[5-[(2-methylsulfonylethylamino)methyl]-2-furyl]quinazolin-4-amine-d7 Ditosylate; Tykerb-d7 Ditosylate; Tyverb-d7 Ditosylate; Lapatinib (D7) Ditosylate Salt; Lapatinib Internal Standard-d7
EINECS	Contact for details

Quality Control

Our Lapatinib-D7 Ditosylate is manufactured under strict quality systems to ensure the high chemical and isotopic purity required for sensitive mass spectrometry applications. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing results for identity, purity (by HPLC), isotopic enrichment, and related substances. We adhere to relevant industry standards for reference materials to support your compliance with GLP and GMP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dry, cool place. This compound is hygroscopic (moisture-sensitive). For long-term storage, consider desiccation and storage under an inert atmosphere to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D7)	≥ 98.0 atom % D
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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