Unique Ingredient Identifier

The Unique Ingredient Identifier (UNII) is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier linked to a substance's molecular structure or descriptive information by the Substance Registration System (SRS) of the Food and Drug Administration (FDA) and the United States Pharmacopeia (USP).

The SRS is used to generate permanent, unique identifiers for substances in regulated products, such as ingredients in drug and biologic products. The SRS uses molecular structure and descriptive information to define a substance and generate the UNII. The primary means for defining a substance is by its molecular structure as represented on a two-dimensional plane. When a molecular structure is not available (e.g., botanicals), the UNII is defined by descriptive information.[1]

The procedures and management of the SRS is provided by the SRS Board which includes experts from both FDA and the United States Pharmacopoeia (USP).[2]

Examples

Preferred TermUNII
Methadone hydrochloride229809935B
MethadoneUC6VBE7V1Z
Water059QF0KO0R

References

  1. ↑ "Substance Registration System – UNII Presentation". fda.gov.
  2. ↑ "Substance Registration System - Unique Ingredient Identifier (UNII)". fda.gov.


This article is issued from Wikipedia. The text is licensed under Creative Commons - Attribution - Sharealike. Additional terms may apply for the media files.