Description

Lapatinib Ditosylate Monohydrate CAS NO 388082-78-8 is a dual tyrosine kinase inhibitor salt form, specifically designed for enhanced pharmaceutical formulation and stability. This high-purity active pharmaceutical ingredient (API) is critical for the development and manufacturing of targeted cancer therapies. It is primarily required by pharmaceutical companies and research institutions engaged in oncology drug development and production.

Application

• Pharmaceutical API: Primary active ingredient in the formulation of anti-cancer medications.
• Oncology Research: Key reference standard and biochemical tool for studying tyrosine kinase inhibition mechanisms.
• Drug Development: Used in preclinical and clinical development of novel therapeutic agents targeting HER2/EGFR pathways.
• Formulation Studies: Employed in the development of solid dosage forms (e.g., tablets) due to its ditosylate monohydrate salt properties.
• Quality Control: Serves as a certified reference material (CRM) for analytical method development and validation in QC laboratories.
• Bulk Manufacturing: Supplied for the commercial-scale production of finished drug products under GMP conditions.

Basic Information

Product Name	Lapatinib Ditosylate Monohydrate
CAS No.	388082-78-8
Molecular Formula	C₃₃H₃₄ClFN₄O₄S • 2(C₇H₈O₃S) • H₂O
Molecular Weight	943.50 g/mol (Anhydrous basis)
Synonyms	Lapatinib ditosylate monohydrate; Lapatinib Ditosylate Hydrate; GW572016 ditosylate monohydrate; Tykerb ditosylate monohydrate; N-[3-Chloro-4-[(3-fluorophenyl)methoxy]phenyl]-6-[5-[[[2-(methylsulfonyl)ethyl]amino]methyl]-2-furanyl]-4-quinazolinamine ditosylate monohydrate; Lapatinib ditosylate salt monohydrate; Lapatinib tosylate monohydrate
EINECS	Contact for details

Quality Control

Our Lapatinib Ditosylate Monohydrate is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for pharmaceutical use, including identity, purity, and impurity profile. Certificates of Analysis (COA) detailing results from HPLC, NMR, and other pharmacopeial tests are provided to guarantee compliance with relevant standards and customer requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept under dry conditions to prevent degradation. For long-term storage, consider desiccated environments.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	1.5% - 3.5%
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm

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