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Answer:

The reference standard label and the reference standard catalogue (“Unit quantity” heading) declare the total amount of material (active substance and excipients, if any) that has been filled in each vial or ampoule; this information is required by customs authorities. This quantity declared is an approximate figure (’ca’), so it should not be considered accurate from an analytical perspective.

Where appropriate, and especially in the case of substances used for titration or assay, the expression of content or potency is mentioned in the leaflet, which states the amount of active substance or the activity/potency expressed in IU or Ph. Eur. Units. This information is also available in the reference standard database under the heading ‘Assigned content’.


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