Health / Medical Topics

    Stability Substance Identifier Terminology

    Definition 1

    Terminology developed to support Substance Identifiers within the Stability Data Standards. (NCI Thesaurus)

    Definition 2

    The official code for a referenced substance (e.g., acetylsalicylic acid), as a single entity or part of a product (e.g., aspirin). For FDA implementation, only the displayName (i.e. the product name) is mandatory, the code values might be provided if available (e.g., when used in other submissions like SPL), please refer to Substance Registration System - Unique Ingredient Identifier (UNII), at http://www.fda.gov/oc/datacouncil/spl.html. If you have a new compound that is not in the Substance Registration System (SRS) it can be registered by contacting fda-srs(at)fda.hhs.gov. The compound can be given a code and the other information about the compound can remain confidential. (Food and Drug Administration)




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