ABSTRACT

An extensive analytical review of raw material supplier batches is generally required to establish draft internal acceptance specifications because no external references describing sterols as raw material exist (34). By this stage the information on the sample should reveal the quality in terms of total level of sterols, the level of each sterol class and possibly each individual sterol, confirming the source, type, and level of impurities (if any). The latter

is not discussed in detail in this context. The classical methods based on TLC-GC provide sufficient detail on the sterol composition within each sterol class and would thus be fine for detailed raw material characterization. However, for the vast number of samples

expected, a dramatic improvement in method speed and a significant reduction of handson time would be required.