Unidentified Impurity

An impurity for which a structural characterisation has not been achieved and that is defined solely by qualitative analytical properties (e.g., chromatographic retention time). [15, 12]


A starting material may be considered uniform when samples drawn from different layers do not show significant differences in the quality control tests which would result in non-conformity with specifications. The following materials may be considered uniform unless there are signs to the contrary: organic and inorganic chemicals; purified natural products; various processed natural products such as fatty oils and essential oils; and plant extracts. The assumption of uniformity is strengthened by homogeneity, i.e. when the consignment is derived from a single batch. [26]

Universal Test

A test which is considered to be potentially applicable to all new drug substances, or all new drug products; e.g., appearance, identification, assay, and impurity tests. [12]

Unspecified Impurity

An impurity that is limited by a general acceptance criterion, but not individually listed with its own specific acceptance criterion, in the new drug substance specification. [15]


A party who utilizes an excipient in the manufacture of a drug product or another excipient. [8]


United States Pharmacopeia/National Formulary [6]