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 (FDA). It classifies substances as chemical, protein, nucleic acid, polymer, 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 stereochemistry is readily available.[5] 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.[5] Polymers are defined by their structural repeating units and physical properties such as molecular weight or properties related to molecular weight (e.g. viscosity). Structurally diverse materials are inherently heterogenous preparations from natural materials such as plantextract and vaccines.[2]
The GSRS is a freely distributable software system provided through a collaboration between the FDA, the National Center for Advancing Translational Sciences (NCATS) and the European Medicines Agency (EMA).[1] 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 (USP).[1]
unique, ingredient, identifier, unii, alphanumeric, identifier, linked, substance, molecular, structure, descriptive, information, generated, global, substance, registration, system, gsrs, food, drug, administration, classifies, substances, chemical, protein, . 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 FDA It classifies substances as chemical protein nucleic acid polymer 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 stereochemistry is readily available 5 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 5 Polymers are defined by their structural repeating units and physical properties such as molecular weight or properties related to molecular weight e g viscosity Structurally diverse materials are inherently heterogenous preparations from natural materials such as plant extract and vaccines 2 The GSRS is a freely distributable software system provided through a collaboration between the FDA the National Center for Advancing Translational Sciences NCATS and the European Medicines Agency EMA 1 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 USP 1 Examples editPreferred Term UNIIMethadone hydrochloride 229809935BMethadone UC6VBE7V1ZOxygen S88TT14065Hydrogen 7YNJ3PO35ZWater 059QF0KO0RReferences edit a b c d Substance Registration System Unique Ingredient Identifier UNII fda gov August 30 2019 a b c Peryea Tyler Southall Noel Miller Mitch Katzel Daniel Anderson Niko Neyra Jorge Stemann Sarah Nguyễn Dắc Trung Amugoda Dammika Newatia Archana Ghazzaoui Ramez Johanson Elaine Diederik Herman Callahan Larry Switzer Frank November 10 2020 Global Substance Registration System consistent scientific descriptions for substances related to health Nucleic Acids Research 49 D1 D1179 D1185 doi 10 1093 nar gkaa962 ISSN 1362 4962 PMC 7779023 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 edit nbsp Wikidata has the property nbsp UNII P652 see uses Substance Registration System Unique Ingredient Identifier UNII Food amp Drug Administration nbsp This pharmacology related article is a stub You can help Wikipedia by expanding it vte Retrieved from https en wikipedia org w index php title Unique Ingredient Identifier amp oldid 1182791702, wikipedia, wiki, book, books, library,
