USP Monographs (Generic Drug Development)
USP monographs are most commonly used for product release testing, but may also be considered during product development. These product-specific monographs call for the use of test equipment not hitherto specified in the general USP/ Ph.Eur. chapters on OIPs and are based on equipment and methods used in the original development of these products.
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The monograph for Fluticasone Propionate Inhalation Powder specified that DDU measurements be conducted with a specific glass sampling apparatus.
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The monograph specified measurement to be conducted using a standard Andersen Cascade Impactor (ACI) equipped with a specially modified induction port. An additional inlet sleeve is provided, effortlessly attachable to the induction port inlet, enabling seamless use with regular mouthpiece adapters found on USP/Next Generation Impactor (NGI) induction ports.
Contrary to the powder method specifying testing at 60 L/min, the monographs recommend using the 28.3L/min version of the ACI (Stages 0 – 7 plus filter stage) for measuring Aerosol Particle Size Distribution (ASPD) for both aerosols and powders.
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