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 called for the use of test equipment not hitherto specified in the general USP/Ph. Eur. chapters on OIP and were based on equipment and methods used in the original development of these products.
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The draft monograph for Albuterol Inhalation Aerosol specified a special glass Sample Collection Apparatus to be used for DDU. The apparatus used a solid plastic firing adapter, instead of a mouthpiece adapter, to accept an inhaler with a circular mouthpiece of corresponding dimensions.
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The draft monograph for Albuterol Inhalation Aerosol specified measurement using standard ACI equipped with a specially modified induction port. A special inlet sleeve is available that slips onto the induction port inlet, enabling the induction port to be used with regular mouthpiece adapters used on USP/NGI induction ports.
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