Drug impurity profiling strategies
✍ Scribed by S. Görög; M. Babják; G. Balogh; J. Brlik; A. Csehi; F. Dravecz; M. Gasdag; P. Horváth; A. Laukó; K. Varga
- Book ID
- 117224068
- Publisher
- Elsevier Science
- Year
- 1997
- Tongue
- English
- Weight
- 776 KB
- Volume
- 44
- Category
- Article
- ISSN
- 0039-9140
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Impurity profiling is the common name of a group of analytical activities, the aim of which is the detection, identification/structure elucidation and quantitative determination of organic and inorganic impurities, as well as residual solvents in bulk drugs and pharmaceutical formulations. Since thi
Besides several known impurities in cimetidine, two additional compounds at levels below 0.1% were detected by ion-pair reversed-phase high-performance liquid chromatography (HPLC). The impurities were isolated from crude cimetidine using normal-phase preparative HPLC. 1H and 13C NMR and mass spectr