Unique ingredient identifier
The Unique Identifier Ingredient (UNII, German about unique ingredient identifier ) is a non-proprietary, clear and non-semantic alphanumeric identifier that is associated with the molecular structure or the description of a substance. It is generated by the Global Substance Registration System (GSRS) of the Food and Drug Administration (FDA).
The UNII consists of ten alphanumeric characters and is used for the permanent and unique identification of substances that are used in regulated products such as pharmaceuticals , biologics , foods and cosmetic products . To create the UNII, the GSRS uses parameters such as molecular structure , amino acid sequences and taxonomic information. The two-dimensional molecular structure is primarily used for definition, taking into account the stereochemistry . Proteins and nucleic acids are defined by their sequences and possibly existing modifications. Polymers are defined on the basis of structural repeat units and molecular mass as well as related properties such as viscosity . Structurally inconsistent materials such as plants are defined using taxonomic information and a sample of the material.
The GSRS is a freely available software system that is made available through a collaboration between the FDA, the National Institutes of Health (NIH) / National Center for Advancing Translational Sciences (NCATS) and the European Medicines Agency . The GSRS was developed to implement the ISO 11238 standard, which is one of the central standards for the ISO identification of pharmaceuticals. There are also GSRS bodies at the US Pharmacopeia , Health Canada , the Federal Institute for Drugs and Medical Devices (BfArM) in Germany and the College ter Beoordeling van Geneesmiddelen (CBG-MEB) in the Netherlands.
Examples
| designation | UNII |
|---|---|
| Methadone hydrochloride | 229809935B |
| Methadone | UC6VBE7V1Z |
| water | 059QF0KO0R |
Individual evidence
- ↑ Inactive Ingredient Search for Approved Drug Products: Frequently Asked Questions - What is a UNII? . In: fda.gov .
- ↑ WHO: 68th Consultation on International Nonproprietary Names for Pharmaceutical Substances, Geneva, April 2-5, 2019 . Executive summary. S. 5 f . ( who.int [PDF]).