Ceritinib is a second-generation tyrosine kinase inhibitor with the chemical name 5-Chloro-N4-[2-[(1-methylethyl)sulfonyl]phenyl]-N2-[5-methyl-2-(1-methylethoxy)-4-(4-piperidinyl)phenyl]-2,4-pyrimidinediamine. This small molecule drug appears as a white to pale yellow crystalline powder with a molecular formula of C28H36ClN5O3S and a molecular weight of 558.14 g/mol. The compound demonstrates limited solubility in aqueous solutions but shows good solubility in organic solvents such as dimethyl sulfoxide (DMSO) and . Structural characterization reveals characteristic peaks in FTIR analysis, including N-H stretching (3300 cm¹), aromatic C=C (1600 cm¹), and sulfonyl S=O (1350 cm¹) vibrations. UV-Vis spectroscopy shows maximum absorption at 289 nm in , while HPLC analysis typically demonstrates purity exceeding 98% with specified impurities below pharmacopeial limits. Ceritinib exhibits pH-dependent solubility, with improved dissolution under acidic conditions (pH 1-3). The drug substance is sensitive to light and moisture, requiring storage in airtight containers at controlled room temperature (20-25°C) with desiccants. Mass spectrometry confirms the molecular ion peak at m/z 558.2 [M+H], and nuclear magnetic resonance (NMR) studies validate the proposed structure. Thermal analysis indicates stability up to 180°C, with decomposition occurring at higher temperatures. The crystalline form has been characterized by X-ray powder diffraction, showing distinctive patterns at 2θ angles of 8.5°, 12.3°, and 17.1°.
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