specified substance group 3
- Guideline or reference source
- ISO11238 IDMP Data elements and structures for the unique identification and exchange of regulated information on substances
- Definition
- refers to the grade of the material along with the source that defines the given grade. Group 3 elements are used to distinguish specific pharmacopoeial and technical grades of material. If the pharmacopoeial monographs related to a substance are not harmonized, the grade for each pharmacopeia can be a separate Group 3 specified substance. NOTE: For most active pharmaceutical substances, typical grades are EP, USP or JP. For herbal substances the grades would be standardized, quantified and unstandardized. EXAMPLE: For the substance Water, the Group 3 specified substance can be Sterile Water for Injection USP.
- Broader Term
- specified substance
- Related Term
- specified substance group 1
- specified substance group 2
Send comments to info@qdossier.com Please read disclaimer before using Qsauri.