Abstract
Description and Identification are universal tests that must be included in the specifications for all new drug substances and drug products. Guidance and recommendations on how to provide clear, complete and precise descriptions and how to select and validate meaningful and specific identity tests are provided. Examples of description statements are given for drug substances, tablets, capsules and oral liquid products. Visual and instrumental methods for quantifying and communication of color attributes and color changes are also discussed. Analytical techniques for drug substance and drug product identification testing include spectroscopic, chromatographic and wet-chemical methods. The need to use tests or combinations of tests that are sufficiently specific to discriminate closely related compounds is stressed.
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