The Unique Ingredient Identifier (UNII) is an alphanumeric identifier linked to a substance's molecular structure or descriptive information and is generated by the Global Substance Registration System (GSRS) of the

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...

(FDA). It classifies substances as

chemical A chemical substance is a form of matter having constant chemical composition and characteristic properties. Some references add that chemical substance cannot be separated into its constituent elements by physical separation methods, i.e., w ...

protein Proteins are large biomolecules and macromolecules that comprise one or more long chains of amino acid residues. Proteins perform a vast array of functions within organisms, including catalysing metabolic reactions, DNA replication, res ...

, nucleic acid,

polymer A polymer (; Greek '' poly-'', "many" + ''-mer'', "part") is a substance or material consisting of very large molecules called macromolecules, composed of many repeating subunits. Due to their broad spectrum of properties, both synthetic a ...

, structurally diverse, or mixture according to the standards outlined by the

International Organization for Standardization The International Organization for Standardization (ISO ) is an international standard development organization composed of representatives from the national standards organizations of member countries. Membership requirements are given in Art ...

in ISO 11238 and ISO DTS 19844. UNIIs are non-proprietary, unique, unambiguous, and free to generate and use. 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." 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 stereochemistry is readily available. Nucleic acids are defined by their sequences and by any modifications that may be present. In the case of proteins only end-group modifications will be uniquely identified, along with any other modifications that are essential for activity. This is because of the inherently heterogenous nature of proteins. Therefore, two different protein substances can share the same UNII and yet have no biosimilarity or therapeutic equivalence. Polymers are defined by their structural repeating units and physical properties such as molecular weight or properties related to molecular weight (e.g.

viscosity The viscosity of a fluid is a measure of its resistance to deformation at a given rate. For liquids, it corresponds to the informal concept of "thickness": for example, syrup has a higher viscosity than water. Viscosity quantifies the inte ...

). Structurally diverse materials are inherently heterogenous preparations from natural materials such as

plant Plants are predominantly photosynthetic eukaryotes of the kingdom Plantae. Historically, the plant kingdom encompassed all living things that were not animals, and included algae and fungi; however, all current definitions of Plantae exclu ...

extract and vaccines. The GSRS is a freely distributable software system provided through a collaboration between the FDA, the

National Center for Advancing Translational Sciences The National Center for Advancing Translational Sciences (NCATS) was established in 2012 and is located in Bethesda, Maryland. NCATS is one of 27 institutes and centers of the US National Institutes of Health (NIH), an agency of the US Departmen ...

(NCATS) and the European Medicines Agency (EMA). The GSRS was developed to implement the ISO 11238 standard which is one of the core ISO Identification of Medicinal Product (IDMP) standards. The GSRS Board which governs the GSRS includes experts from FDA, European Regulatory Agencies, and the

United States Pharmacopoeia The ''United States Pharmacopeia'' (''USP'') is a pharmacopeia (compendium of drug information) for the United States published annually by the United States Pharmacopeial Convention (usually also called the USP), a nonprofit organization that ...

(USP).

Examples

References

External links

Substance Registration System , Unique Ingredient Identifier (UNII) - Food & Drug Administration
Pharmacological classification systems {{pharma-stub