OverviewUSP monographs for inhalation products are referenced for both product release testing and product development. The Fluticasone Propionate (FP) inhalation aerosol monograph defines dedicated sampling and impactor arrangements to ensure monograph‑compliant measurements.
FP Aerosol — Key informationThe FP monograph distinguishes apparatus and flow requirements for Delivered Dose Uniformity (DDU) and Aerodynamic Particle Size Distribution (APSD). It references specialised induction port and inlet geometries and specifies the use of a modified Andersen Cascade Impactor (ACI) configuration for APSD.
DDU (Delivered Dose Uniformity)DDU testing for FP aerosols requires a specific glass sampling apparatus as specified in the monograph. This apparatus is used to collect emitted dose samples for uniformity assessment.
APSD (Aerodynamic Particle Size Distribution)APSD measurement is specified using an Andersen Cascade Impactor (ACI) adapted for FP aerosols and powders. The monograph references a specially modified induction port (common to aerosols and powders), a modified inlet cone for aerosols and a preseparator for powders. The APSD method in the FP monograph references the 28.3 L/min ACI configuration (Stages 0–7 plus filter stage), despite alternative powder‑method flow rates elsewhere.
Products featured (as referenced on this page)- Sample collection apparatus for FP/Salmeterol aerosols
- Andersen Cascade Impactor (ACI) configured for FP testing
- FP/Salmeterol induction port
- ACI inlet cone for FP/Salmeterol aerosols
NotesThis summary presents equipment and accessory references cited in the USP monograph for Fluticasone Propionate inhalation aerosols and FP/Salmeterol methods. It clarifies the difference in apparatus and flow requirements between DDU and APSD procedures and lists product components used to meet monograph requirements.
Technical characteristics / specifications- Monograph target: Fluticasone Propionate (FP) inhalation aerosol
- DDU sampling: specific glass sampling apparatus required by the monograph
- APSD measurement: Andersen Cascade Impactor (ACI) with specially modified induction port
- ACI configuration: 28.3 L/min version (Stages 0–7 plus filter stage) specified for APSD
- Aerosol accessories: modified inlet cone for FP/Salmeterol aerosols; preseparator referenced for powders
- Featured components: Sample collection apparatus for FP/Salmeterol aerosols; FP/Salmeterol induction port; ACI inlet cone for FP/Salmeterol aerosols