OverviewUSP draft monographs for Albuterol inhalation aerosol describe product-specific test requirements used for product release testing and development. Notes specify specialized sampling and impactor configurations required to assess Delivered Dose Uniformity (DDU) and Aerodynamic Particle Size Distribution (APSD).
Albuterol (DDU) — Draft monograph notesThe draft monograph specifies a glass Sample Collection Apparatus for DDU sampling of Albuterol aerosol. This apparatus accepts an inhaler with a circular mouthpiece via a solid plastic firing adapter rather than a standard mouthpiece adapter.
Products featured for DDU (from the monograph notes)- Sample Collection Apparatus for Albuterol Aerosol
- Firing Adapter
Albuterol (APSD) — Draft monograph notesAPSD measurement in the draft monograph uses a standard Andersen Cascade Impactor (ACI) fitted with a specially modified induction port. An optional inlet sleeve can be fitted over the induction port inlet to allow use with regular mouthpiece adapters typically used on USP/NGI induction ports.
Products featured for APSD (from the monograph notes)- Andersen Cascade Impactor (ACI)
- Albuterol Induction Port
- Albuterol Induction Port Sleeve (Optional)
Technical characteristics / specifications- Scope: Notes describe USP draft monograph requirements for Albuterol inhalation aerosol testing covering DDU and APSD.
- Sample Collection Apparatus (DDU): Special glass apparatus specified for DDU sampling; interfaces with inhalers using a solid plastic firing adapter for circular mouthpieces.
- Firing Adapter: Solid plastic firing adapter designed to mate inhalers to the Sample Collection Apparatus specified in the draft monograph.
- APSD measurement: Uses standard Andersen Cascade Impactor (ACI) with a specially modified induction port and optional inlet sleeve to adapt for regular mouthpiece adapters.
- Referenced products: Andersen Cascade Impactor (ACI), Albuterol Induction Port, Albuterol Induction Port Sleeve, Sample Collection Apparatus for Albuterol Aerosol, Firing Adapter.