Lu, Yuting; Shen, Xiaoyue; Hang, Taijun; Song, Min published the artcile< Identification and characterization of process-related substances and degradation products in apremilast: Process optimization and degradation pathway elucidation>, Product Details of C12H19NO4S, the main research area is apremilast degradation product analysis LC MS process optimization; Apremilast; LC–MS; Process optimization; Related substances.
This study aims at investigating the separation, identification and characterization of related substances in apremilast by LC-MS hyphenated techniques, as well as the synthesis optimization and the degradation pathways elucidation. Forced degradation studies were conducted under the ICH prescribed stress conditions. The chromatog. separation was achieved on XBridge C18 column (4.6 mm × 150 mm, 3.5 μm) using a mobile phase consisting of water adjusted to pH 3.0 with formic acid as solvent A and acetonitrile as solvent B in linear gradient elution program. Twelve related substances were detected all together in apremilast and its stress samples. Their structures were identified mainly through pos. ESI high-resolution TOF-MS anal. of the parent ions’ accurate masses and elemental compositions, and the corresponding MS/MS spectra elucidation. There were three process-related substances and nine degradation products, seven of them were first reported. Two degradation products and one process-related substance were further verified by semi-preparation and NMR determination Their origins and formation mechanisms were also discussed, based on which effective approaches for the synthesis optimization were conducted. Therefore, the related substances investigation are valuable for apremilast manufacturing process optimization and quality control.
Journal of Pharmaceutical and Biomedical Analysis published new progress about Chromatography. 608141-42-0 belongs to class ethers-buliding-blocks, and the molecular formula is C12H19NO4S, Product Details of C12H19NO4S.
Referemce:
Ether – Wikipedia,
Ether | (C2H5)2O – PubChem