Establishment of a knowledge base for identification of residual solvents in pharmaceuticals |
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| Authors: | Liu Ying Hu Chang-Qin |
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| Institution: | a National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050, People's Republic of China
b Institute of Medicinal Biotechnology, Chinese Academy of Medical Science and Peking Union Medial College, Beijing 100050, People's Republic of China |
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| Abstract: | A knowledge base for identification of residual solvents in pharmaceuticals has been established using gas chromatograph-mass spectrometry (GC-MS) and gas chromatograph-Fourier transform infrared spectrometry (GC-FTIR). Sixty solvents were studied according to the guideline for residual solvents regulated by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The standard mass spectra library, the limit of detection (LOD) mass spectra library, the standard vapor-phase infrared spectra library, and the limit of detection (LOD) vapor-phase infrared spectra library were established and constituted the knowledge base. Using the knowledge base, the problem of qualitation, which was the difficulty of determining residual solvents, can be resolved. |
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| Keywords: | Identification Gas chromatograph-mass spectrometry Gas chromatograph-Fourier transform infrared spectrometry Knowledge base Spectra library Residual solvents in pharmaceuticals |
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