quantitative composition
- Guideline or reference source
- ISO11615 IDMP Data elements and structures for the unique identification and exchange of regulated medicinal product information
- Definition
- amounts of substance and specified substance constituents of the investigational/authorized medicinal product expressed in a ratio scale NOTE 1 It is necessary for the quantitative composition of the substance(s) or the specified substance descriptions of the finished investigational or authorized Medicinal Products (depending on the pharmaceutical form concerned) to specify the mass, or the number of units of biological activity, either per dosage unit or per unit of mass or volume, of each substance or specified substance. NOTE 2 Substance or specified substance descriptions present in the form of compounds or derivatives are always designated quantitatively by their total mass and, if necessary or relevant, by the mass of active entity, or entities, of the molecule.
- Broader Term
- concentration
- Related Term
- qualitative composition
- strength
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