MEDIOCON INC – Lapatinib Ditosylate is the ditosylate salt form of lapatinib, a synthetic 4-anilinoquinazoline tyrosine kinase inhibitor. Lapatinib targets human epidermal growth factor receptor 2 (HER2/ErbB2) and epidermal growth factor receptor (EGFR/HER1) tyrosine kinases and is used in oncology-related pharmaceutical applications. The marketed pharmaceutical form is lapatinib ditosylate monohydrate.
Lapatinib Ditosylate is a salt form of lapatinib containing two molecules of p-toluenesulfonic acid. The monohydrate form additionally contains one molecule of water per salt unit. Lapatinib is a member of the 4-anilinoquinazoline class of kinase inhibitors and acts by inhibiting intracellular EGFR and HER2 tyrosine kinase activity.
Product Name: Lapatinib Ditosylate
Pharmaceutical Form: Lapatinib Ditosylate Monohydrate
CAS Number: 388082-78-8
Molecular Formula: C₄₃H₄₄ClFN₄O₁₁S₃
Molecular Weight: Approximately 943.5 g/mol
Chemical Class: 4-Anilinoquinazoline tyrosine kinase inhibitor
Synonyms: Lapatinib ditosylate monohydrate, Lapatinib tosylate, Lapatinib ditoluenesulfonate monohydrate, GW572016F
Parent Compound: Lapatinib
Parent Compound CAS: 231277-92-2
Lapatinib is an intracellular tyrosine kinase inhibitor that inhibits phosphorylation of EGFR/HER1 and HER2/ErbB2 receptors. By inhibiting these receptor tyrosine kinases, lapatinib interferes with downstream signaling pathways involved in tumor-cell proliferation and survival.
The active pharmaceutical ingredient in marketed lapatinib tablets is present as the monohydrate of the ditosylate salt. FDA labeling identifies the molecular weight of the lapatinib ditosylate monohydrate as 943.5 g/mol.
MEDIOCON INC focuses on supplying pharmaceutical and specialty chemical ingredients with emphasis on quality, consistency, technical documentation and reliable supply.
Lapatinib Ditosylate quality evaluation may include identification, assay, chromatographic purity, related substances, residual solvents, water content, residue on ignition, elemental impurities and other parameters according to the applicable product specification.
Because the material is specifically the ditosylate monohydrate salt, control of water/solvation state and salt-form identity may also be relevant to the applicable specification.
The exact analytical acceptance criteria should be confirmed against the current approved specification and batch-specific Certificate of Analysis.
Lapatinib is an established antineoplastic tyrosine kinase inhibitor used in oncology. It targets HER2/ErbB2 and EGFR/HER1 signaling and has been used in the treatment of certain HER2-positive breast cancers in accordance with approved prescribing information and combination regimens.
Lapatinib Ditosylate Monohydrate is a yellow solid. FDA labeling reports water solubility of approximately 0.007 mg/mL and solubility of approximately 0.001 mg/mL in 0.1 N hydrochloric acid at 25°C.
The monohydrate has molecular formula C₄₃H₄₄ClFN₄O₁₁S₃ and molecular weight approximately 943.5 g/mol.
Product availability, packaging configuration, Certificate of Analysis (COA), Safety Data Sheet (SDS/MSDS), technical specifications and other documentation should be confirmed with MEDIOCON INC according to the intended application and customer requirements.
| Parameter | Specification |
|---|---|
| Appearance | Yellow solid |
Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Lapatinib Ditosylate API Manufacturer and Supplier in India (CAS 388082-78-8) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.
Our Lapatinib Ditosylate API Manufacturer and Supplier in India is manufactured under strict quality management protocols compliant with WHO-GMP, ISO 9001:2015, and major pharmacopoeial standards (IP, BP, USP, EP). Every batch undergoes full analytical testing before release with a Certificate of Analysis.
Export Markets
Quality & Compliance