title: Estimation of impurity profiles in drugs and related materials.
abstract: The estimation of impurity profiles in drugs and related materials has been demonstrated using combinations of chromatographic and spectroscopic techniques. Examples chosen to illustrate this approach are: (1) an examination of flumecinol and its impurities using packed column GC-mass spectrometry; (2) the estimation of 17beta-ethinyl-17alpha-hydroxy impurities in 17alpha-ethinyl-17beta-hydroxy steroids using capillary GC; (3) the identification of impurities in hexoestrol using HPLC-linear photodiode array detection (LDA) and off-line mass spectrometry; (4) the estimation of 9(11)-dehydromestranol in mestranol using HPLC-LDA; and (5) the estimation of an l-threo impurity in a d-threo hydroxy acid intermediate using a chiral column containing covalently bonded bovine serum albumin.
authors.affiliation: Chemical Works Gedeon Richter Ltd., P.O. Box 27, H-1475 Budapest, Hungary.
authors.forename: S
authors.initials: S
authors.lastname: Görög
authors.forename: A
authors.initials: A
authors.lastname: Laukó
authors.forename: B
authors.initials: B
authors.lastname: Herényi