DEFINING DRUG PURITY THROUGH CHROMATOGRAPHIC AND RELATED METHODS - CURRENT STATUS AND PERSPECTIVES

Authors
KRSTULOVIC AM LEE CR
Citation
Am. Krstulovic et Cr. Lee, DEFINING DRUG PURITY THROUGH CHROMATOGRAPHIC AND RELATED METHODS - CURRENT STATUS AND PERSPECTIVES, Journal of chromatography B. Biomedical sciences and applications, 689(1), 1997, pp. 137-153
Citations number
2
Categorie Soggetti
Chemistry Analytical","Biochemical Research Methods
Journal title
Journal of chromatography B. Biomedical sciences and applications → ACNP
ISSN journal
13872273
Volume
689
Issue
1
Year of publication
1997
Pages
137 - 153
Database
ISI
SICI code
0378-4347(1997)689:1<137:DDPTCA>2.0.ZU;2-L
Abstract
Chromatographic and electrophoretic techniques play a preeminent role in assessing the quality of drug substances and drug products. Current ICH guidelines place in a legal framework what has been common practi ce in modern pharmaceutical research and quality control. This paper r eviews some aspects of current requirements for evaluating the purity of chemically synthesized new drug substances and drug products, and s uggests some possible future trends.