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  • Quantitative declaration: The quantity of the active substance must be expressed per dosage unit (for metered dose inhalation products - per delivered dose and/or per metered dose), per unit volume, or per unit of weight and must be related to the declaration of strength in the section above entitled ‘Name of the Medicinal Product.’ Salts and hydrates Where the active substance is present in the form of a salt or hydrate, the quantitative composition should be expressed in terms of the mass (or biologic activity in International [or other] Units where appropriate) of the active entity (base, acid, or anhydrous material), eg, ‘60 mg toremifene (as citrate) or ‘toremifene citrate equivalent to 60 mg toremifene.’ Where a salt is formed in situ during manufacture of the finished product, the quantity of the active entity should be stated, with a reference to the in situ formation of the salt. (cs)
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