The Unique Ingredient Identifier (UNII) is an alphanumeric identifier linked to a substance's

molecular structure Molecular geometry is the three-dimensional arrangement of the atoms that constitute a molecule. It includes the general shape of the molecule as well as bond lengths, bond angles, torsional angles and any other geometrical parameters that determ ...

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., wi ...

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, respo ...

nucleic acid Nucleic acids are biopolymers, macromolecules, essential to all known forms of life. They are composed of nucleotides, which are the monomers made of three components: a 5-carbon sugar, a phosphate group and a nitrogenous base. The two main cl ...

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 In chemistry, a mixture is a material made up of two or more different chemical substances which are not chemically bonded. A mixture is the physical combination of two or more substances in which the identities are retained and are mixed in the ...

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 Ar ...

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 Stereochemistry, a subdiscipline of chemistry, involves the study of the relative spatial arrangement of atoms that form the structure of molecules and their manipulation. The study of stereochemistry focuses on the relationships between stereois ...

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 A physical property is any property that is measurable, whose value describes a state of a physical system. The changes in the physical properties of a system can be used to describe its changes between momentary states. Physical properties are o ...

such as

molecular weight A molecule is a group of two or more atoms held together by attractive forces known as chemical bonds; depending on context, the term may or may not include ions which satisfy this criterion. In quantum physics, organic chemistry, and bioch ...

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 exclud ...

extract An extract is a substance made by extracting a part of a raw material, often by using a solvent such as ethanol, oil or water. Extracts may be sold as tinctures, absolutes or in powder form. The aromatic principles of many spices, nuts, h ...

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 The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of medicinal products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or Euro ...

(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