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The monograph for Fluticasone Propionate Inhalation Aerosol specified that DDU measurements be conducted using a specific glass sampling apparatus.
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The monograph specified APSD measurement to be conducted using a standard Andersen Cascade Impactor (ACI) equipped with a specially modified induction port common to both aerosols and powders. Additionally, a specially modified inlet cone and preseparator are utilised for aerosols and powders, respectively.
As per the monographs, the 28.3 L/min version of the ACI (Stages 0 – 7 plus filter stage) should be employed to measure Aerodynamic Particle Size Distribution (ASPD) for both aerosols and powders, even though the powder method specifies testing at 60 L/min.
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