specified substance group 1
- Guideline or reference source
- ISO11238 IDMP Data elements and structures for the unique identification and exchange of regulated information on substances
- Definition
- Refers to material that contains multiple substances, solvents used in the preparation of herbal or allergenic extracts, specific marker or signature substances present in materials derived from biological matrices, the physical form of a substance when relevant and any properties essential to the description of the material. It includes constituents, physical form and property. Constituents consist of intended substances added to create a multi-substance material, solvents used in the preparation of extracts, marker or signature substances present in animal derived material. Impurities or degradents can not be constituents for Group 1 specified substances. NOTE 1: This grouping of constituents allows for the definitions of many materials in commerce that are used in the formulation of medicinal products.
- Broader Term
- specified substance
- Related Term
- specified substance group 2
- specified substance group 3
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