substance
- Guideline or reference source
- ISO11238 IDMP Data elements and structures for the unique identification and exchange of regulated information on substances
- ISO11615 IDMP Data elements and structures for the unique identification and exchange of regulated medicinal product information
- ISO11616 IDMP Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information
- Definition
- any matter that has discrete existence, whose origin may be biological, mineral or chemical NOTE 1 Substances may be either single substances or mixture substances. NOTE 2 Single substances are always defined using a minimally sufficient set of data elements divided into five types, chemical, protein, nucleic acid, polymer, and structurally diverse. Substances may be salts, solvates, free acids, free bases, mixtures of related compounds that are either isolated or synthesized together. NOTE 3 Pharmacopeial terminology and defining characteristics are used when available and appropriate. Defining elements are dependent on the type of substance. NOTE 4 Discrete existence refers to the ability of a substance to exist independently of any other substance. Substances may either be well-defined entities containing definite chemical structures, synthetic (i.e. isomeric mixtures) or naturally-occurring (i.e. conjugated estrogens) mixtures of chemicals containing definite molecular structures, or materials derived from plants, animals, microorganisms or inorganic matrices for which the chemical structure may be unknown or difficult to define.
- Narrower Term
- active substance
- approved substance
- chemical
- ingredient
- mixture substance
- polymer
- specified substance
- Related Term
- material
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