Betekenis van:
monograph

Voorbeeldzinnen

1. European Pharmacopoeia monograph reference
2. Fennel, bitter, dried comminuted [1] fruit.European Pharmacopoeia monograph reference
3. Excipients shall comply with the requirements of the appropriate European Pharmacopoeia monograph.
4. Packaging materials shall comply with the requirements of the appropriate European Pharmacopoeia monograph.
5. In the absence of a pharmacopoeial monograph a specification shall be proposed and justified.
6. Fennel, sweet, dried comminuted [3] or powdered fruit.European Pharmacopoeia monograph reference
7. The description shall be given in the form of a monograph under the following headings:
8. In this case the suitability of this monograph shall be demonstrated.
9. The description shall be given in the form of a monograph.
10. In the absence of a European Pharmacopoeia monograph for an active substance, and where the active substance is described in the pharmacopoeia of a Member State, that monograph may be applied.
11. In the absence of such a monograph reference may be made to the Pharmacopoeia of a third country.
12. Data to demonstrate the ability of the monograph to adequately control the quality of the active substance shall be presented.
13. Where such a monograph does not exist reference may be made to the pharmacopoeia of a Member State. In the absence of such a monograph reference may be made to the pharmacopoeia of a third country.
14. Where such a monograph does not exist reference may be made to the pharmacopoeia of a Member State. In the absence of such a monograph reference may be made to the Pharmacopoeia of a third country.
15. In the absence of such a monograph reference may be made to the pharmacopoeia of a third country.