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Examples: parenteral solutions, unit dose nebuliser solutions

The unit of presentation usually either uses the same word (even though it is a different concept) as the (package item) container, or the (package item) container is a more granular concept and the unit of presentation uses a less granular term.
Presentation strength is expressed as "per the amount of liquid bounded by the unit of presentation" but concentration strength is per mL (and therefore is often different).

Example 1: A pack of 10 ampoules each containing 20mL of metoclopramide hydrochloride for solution for injection



Manufactured dose formSolution for injection
Unit of presentationAmpouleThe ampoule "bounds" the liquid
[Pack size]10 ampoules in the box
Precise active ingredientmetoclopramide hydrochloride
Basis of strength substancemetoclopramide hydrochloride
Presentation strength (logical)100 mg per volume contained in the unit of presentationThe amount of the dose form bounded in the unit of presentation
Presentation strength100 mg per 20 mL
Concentration strength5 mg per 1 mL


Example 2:  A pack of 20 UDVs each containing 2mL of ipratropium bromide for solution for nebulisation

Manufactured dose formSolution for nebulisation
Unit of presentationUnit dose vialThe vial "bounds" the liquid
[Pack size]5 vials in a sleeve, 4 sleeves in the box
Precise active ingredientipratropium bromide
Basis of strength substanceipratropium bromide
Presentation strength (logical)500 mcg per volume contained in the unit of presentationThe amount of the dose form bounded in the unit of presentation
Presentation strength500 mcg per 2 mL
Concentration strength250 mcg per 1 mL



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