OverviewUSP monographs are commonly used for product release testing and are considered during product development. Certain product‑specific monographs for FP/S inhalation powders require test equipment and sampling methods beyond those specified in general USP/Ph. Eur. chapters; these are based on methods used in the original product development.
DDU (Delivered Dose Uniformity)The FP/S inhalation powder monograph specifies that DDU measurements be performed using a dedicated glass sample collection apparatus designed for FP/S powders.
Products featured here- Sample collection apparatus for FP/S powders
APSD (Aerosol Particle Size Distribution)The monograph prescribes APSD measurement with a standard Andersen Cascade Impactor (ACI) fitted with a modified induction port. An additional inlet sleeve is supplied to adapt the induction port for use with common mouthpiece adapters found on USP/NGI induction ports.
Although powder methods sometimes specify testing at 60 L/min, the FP/S monograph recommends using the 28.3 L/min configuration of the ACI (Stages 0–7 plus filter stage) for APSD measurement of both powders and aerosols.
Products featured here- Andersen Cascade Impactor (ACI)
- ACI preseparator for FP/S powders
- ACI inlet cone for FP/S aerosols
Technical features / specifications- Applicable monographs: Fluticasone Propionate (FP) and FP/S (Fluticasone Propionate with Salmeterol) inhalation powder monographs
- DDU sampling: specific glass sample collection apparatus as specified in the FP/S monograph
- APSD measurement: standard Andersen Cascade Impactor (ACI) with modified induction port and optional inlet sleeve for compatibility with standard mouthpiece adapters
- Recommended ACI flow for APSD: 28.3 L/min (Stages 0–7 plus filter stage); note the powder method may specify 60 L/min but the FP/S monograph advises 28.3 L/min when using the ACI
- Products and accessories referenced: sample collection apparatus for FP/S powders, ACI, ACI preseparator and ACI inlet cone for FP/S applications
- Intended for testing FP/S powders and related aerosols in accordance with USP and Ph. Eur. monograph guidance