Approaches to Drug Sample Differentiation. I: A Conceptual Review
1981; Wiley; Volume: 26; Issue: 4 Linguagem: Inglês
10.1520/jfs11418j
ISSN1556-4029
Autores Tópico(s)Statistical Methods in Clinical Trials
ResumoAbstract Differentiation of drug samples can be based on at least three different approaches. Conventional methods use qualitative and quantitative determinations of impurities or minor components. Samples may also be differentiated by variations in a naturally occurring isotope such as carbon-13, whose content varies because of differences of carbon fixation conditions for cultivated plant drugs or from differences in reaction conditions for synthesized drugs. A third approach involves the determination of various diastereoisomeric or enantiomeric compositions or both. This last approach also serves an essential purpose in cases where one isomer is under regulation while other(s) may not be. Representative works are reviewed.
Referência(s)