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 liquids products. Visual and instrumental methods for quantifying and communication 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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