Although standardized test methods are available from many nationally recognized sources, there may be occasions when they cannot be used or when no standard method exists for a particular constituent or characteristic. Therefore, method development may be required. Method development is the set of experimental procedures devised for measuring a known amount of a constituent in various matrices, in the case of chemical analyses; or a known characteristic (e.g., biological or toxicological) of various matrices.
The guidance provided in this section is generalized and slanted toward chemical analyses in most cases. Bioassays, taxonomic classification, and microbiology testing frequently demand additional or alternative considerations during development and validation. In some cases, these may be spelled out in other parts of this compendium (e.g. Parts 8000, 9000, 10000) or from other publications or regulatory authorities.