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 17β-ethinyl-17α-hydroxy impurities in 17α-ethinyl-17β-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.
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