Answer:

The reference standard label and the reference standard catalogue (heading “Unit quantity”) declare the total amount of material (active substance and excipients, if any) which has been filled in each vial or ampoule as this information is requested by the customs. This quantity is declared circa (“ca”), so this quantity is not to be considered accurate from an analytical point of view.

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 catalogue under the heading “Assigned content”.