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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, 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.
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 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.
Degradation of Lapatinib impurities is controlled by implementing proper storage conditions, such as temperature and humidity controls, and using appropriate packaging materials.
Yes, formulation adjustments can minimize impurities in Lapatinib, such as optimizing the pH, solvent selection, or using stabilizing agents.
Lapatinib impurities are controlled during manufacturing through strict quality control measures, such as process optimization, purification techniques, and adherence to good manufacturing practices (GMP).
Lapatinib impurities are analyzed using various analytical techniques, such as high-performance liquid chromatography (HPLC) or liquid chromatography (LC).
The recommendation is to store Lapatinib impurities at controlled room temperature, within 2-8 °C.
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