Validation of trace analytical methods

Validation of analytical methods is important both from the standpoint of good science and to satisfy regulators of the reliability of results reported in dossiers. When approaching validation of any analytical method, one must always ensure that the method is fit for purpose. The amount of resource should be appropriate to the phase of development and the degree to which the process is defined and the methods finalised. 

The first decision that must be taken when considering validation is whether the analyte should be quantified, or whether a limit test should be used. The latter involves significantly less validation and is recommended wherever possible. ICH Q2A requires only specificity and sensitivity for limit tests of impurities [81]. However, when one is considering trace impurities, scientific judgement 

1 -bromo-octadecane 1-chloro-octadecane ethyl methanesulfonate ethyl p-toluenesulfonate many other alkylating pollutants 

Derivatisation with NBP 4-pyridinecarboxaldehyde 4-nitropheny Ihydrazone 4-pyridinecarboxaldehyde 2-benzothiazolylhydrazone 4-acetylpyridine 4-nitrophenyIhydrazone 4-acetylpyridine 2-benzothiazolyUiydrazone 

Bis-(2-chloroethyl)amine Tissue bis-(2-chloroethyl)methylamine homogenates 

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