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Validation by Type of Method

Authored by: Michael E. Swartz , Ira S. Krull

Handbook of Analytical Validation

Print publication date:  April  2012
Online publication date:  April  2012

Print ISBN: 9780824706890
eBook ISBN: 9781420014488
Adobe ISBN:


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Regulatory guidelines recognize that is it not always necessary to evaluate every analytical performance parameter for every type of method or analytical procedure, or for both drug substances (active pharmaceutical ingredient [API]) and drug products, as discussed in Chapter 4 [1,2]. Several different types of methods are used to measure the API or impurities, degradants, excipients, and additional related substances either in the raw material or finished product during various stages of drug development. The methods discussed in this chapter are impurity (related substances) or stability indicating methods (SIMs), dissolution, bioanalytical methods, peptide mapping, and methods used in support of cleaning validation. The type of method and its intended use, as well as the phase of development, dictate which performance characteristics should be investigated, as summarized in Table 7.1. Both the USP and ICH divide analytical methods into four separate categories:

Category I: Assays for the quantitation of major components or active ingredients

Category II: Determination of impurities or degradation products

Category III: Determination of performance characteristics

Category IV: Identification tests

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