Unique Ingredient Identifier
The Unique Ingredient Identifier (UNII) is an alphanumeric identifier linked to a substance's
structurally diverse, or mixture[1][2] according to the standards outlined by the International Organization for Standardization in ISO 11238[3] and ISO DTS 19844.[4] UNIIs are non-proprietary, unique, unambiguous, and free to generate and use.[2] A UNII can be generated for substances at any level of complexity, being broad enough to include "any substance, from an atom to an organism."[1]
The GSRS is used to generate permanent, unique identifiers for substances in regulated products, such as ingredients in drug and biological products. The GSRS uses molecular structure, protein and nucleic sequences and descriptive information to generate the UNII. The preferred means for defining a chemical substance is by its two-dimensional molecular structure since it is pertinent to a substance's identity and information regarding a substance's
The GSRS is a freely distributable software system provided through a collaboration between the FDA, the
United States Pharmacopoeia (USP).[1]
Examples
| Preferred Term | UNII |
|---|---|
| Methadone | UC6VBE7V1Z |
Methadone hydrochloride |
229809935B |
| Oxygen | S88TT14065 |
| Hydrogen | 7YNJ3PO35Z |
| Water | 059QF0KO0R |
References
- ^ a b c d "Substance Registration System - Unique Ingredient Identifier (UNII)". fda.gov. August 30, 2019.
- ^ PMID 33137173.
- ^ "ISO 11238:2018". ISO. October 20, 2017. Retrieved November 25, 2020.
- ^ "ISO/TS 19844:2018". ISO. Retrieved November 25, 2020.
- ^ a b "Substance Definition Manual". fda.gov. June 10, 2007. Retrieved November 25, 2020.
External links
Wikidata has the property:
UNII (P652) (see uses)
