Lapatinib

General Information

Lapatinib Impurities and Lapatinib

Daicel Pharma offers worldwide delivery options for custom synthesis of Lapatinib impurities, including impurities such as Lapatinib Impurity 5, Lapatinib Impurity A, Lapatinib Impurity B, Lapatinib Impurity D, Lapatinib Impurity E, Lapatinib Impurity F, Lapatinib Impurity G, Lapatinib Impurity H, Lapatinib Impurity I, and Lapatinib nitroso impurity. These impurities evaluate the purity and safety of Lapatinib, an active pharmaceutical ingredient.

With its antineoplastic properties, Lapatinib [CAS: 231277-92-2] is an oral synthetic quinazoline compound. It acts as an inhibitor of tyrosine kinases, targeting the epidermal growth factor receptor and HER2 (receptor, ERBB-2). It treats advanced or metastatic breast cancer, particularly in cases where the tumors exhibit overexpression of HER2.

Lapatinib: Use and Commercial Availability  

Lapatinib, marketed under the brands, Tyverb and Tykerb, treats patients with breast cancer whose tumors overexpress the human epidermal receptor type 2 (HER2) protein. It treats advanced or metastatic breast cancer and can occur in various combinations depending on the patient’s treatment history and disease stage.

Lapatinib Structure and Mechanism of Action

The chemical name of Lapatinib is N-[3-Chloro-4-[(3-fluorophenyl)methoxy]phenyl]-6-[5-[[[2-(methylsulfonyl)ethyl]amino]methyl]-2-furanyl]-4-quinazolinamine. Its chemical formula is C₂₉H₂₆ClFN₄O₄S, and its molecular weight is approximately 581.1 g/mol.

Lapatinib blocks epidermal growth factor receptor, ErbB-driven tumor cell growth.

Lapatinib Impurities and Synthesis

Lapatinib is an anticancer medication for treating breast and other cancers. Like other pharmaceuticals, Lapatinib can contain impurities. They can originate from the manufacturing process¹ or external sources. The common Lapatinib impurities in Lapatinib formulations include related substances, such as isomers or degradation products. They may arise during synthesis or storage, resulting from temperature, humidity, or exposure to light. Manufacturers carefully monitor and control the levels of impurities in Lapatinib to ensure its quality, safety, and effectiveness. Rigorous quality control measures are employed to minimize them and maintain the highest possible pharmaceutical standards.

Daicel Pharma strictly adheres to cGMP standards and operates an analytical facility for the preparation of Lapatinib impurities. We provide a range of Lapatinib impurity standards, such as Lapatinib Impurity 5, Lapatinib Impurity A, Lapatinib Impurity B, Lapatinib Impurity D, Lapatinib Impurity E, Lapatinib Impurity F, Lapatinib Impurity G, Lapatinib Impurity H, Lapatinib Impurity I, and Lapatinib nitroso impurity. Our impurities have a detailed Certificate of Analysis (CoA) and a comprehensive characterization report. The CoA encompasses data obtained through techniques, 1H NMR, 13C NMR, IR, MASS, and HPLC purity analysis². Additional data, such as 13C-DEPT, can be provided upon request. We can synthesize unknown Lapatinib impurities, degradation products, and labeled compounds to evaluate the efficacy of generic Lapatinib. Each delivery accompanies a comprehensive characterization report.