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Mass Balance Criteria (Uniformity of Dosage Units) Where possible, all laboratory measurements using pMDIs are validated by the dose uniformity criteria of the United States Pharmacopeia (USP 24) <601> for Uniformity of Dosage Units. All components of the inhaler/device combination are assayed for active ingredient and compared to the Label Claim of the inhaler. Under section <601> of the USP the total mass of drug collected on all the components divided by the number of doses discharged should not be less than 75% and or more than 125% of the label claim. If the result falls outside of these limits the test is repeated. Label Claim is the unit total dose specified by the manufacturer of the inhaler. For those formulations for sale in the USA, label claim dose is specified ex-actuator mouthpiece. Whereas, for pMDIs offered for sale in Canada, label claim is specified as ex-metering valve, and therefore includes that portion of the dose retained on the metering valve stem and within the actuator mouthpiece. United States Pharmacopeia European Pharmacopeia
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