Toxicological Analysis—General Considerations

In toxicology, there is no such problem as a search for an unknown alkaloid, as there is nothing to differentiate poisoning by an alkaloid from poisoning by any other type of drug. The search for an alkaloid is simply part of the search for an unknown organic poison. It is now pro- 

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Weil, C.S. (1962). Applications of methods of statistical analysis to efficient repeated-dose toxicological tests. I. General considerations and problems involved. Sex differences in rat liver and kidney weights. Toxicol. Appl. Pharmacol. 4 561-571. 

In cases where a general QL is required, as in pharmaceutical analysis, it is essential to define a realistic QL (or DL) for the analytical procedure, independently from the equipment used, because this limit has important consequences (e.g., for the consistent reporting of impurities or for method transfer). They may be derived by taking QL (or DL) from various instruments into account ( intermediate QL, during the development process) or can be defined taking the requirements of the control test (specification limits imposed by toxicology or by a qualified impurity profile) into consideration. For example, a QL which... 

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