Dose Content Uniformity (Within Batch)

Dose Content Uniformity (Within Batch)

  • Stock: In Stock
  • Category : Inhaled Drug

<p>Dose content uniformity (DCU) is the test which ensures the uniform distribution of active drugs in the MDIs/DPIs/NSPs/Nebulizers of a batch. The same test for Nasal Spray (NSP) is called Spray Content Uniformity (SCU) which is also performed within a batch. The test checks the active drug content of a number of MDIs/DPIs/NSPs/Nebulizers from a batch. For Example, 10 MDI units are randomly collected from a lot. Then the 10 MDIs are actuated in 10 different collection tubes to collect the doses.</p>

Dose Inhaler (MDI), Dry Powder Inhaler (DPI), Nasal Spray (NSP) and Nebulizer.

Dose content uniformity (DCU) is the test which ensures the uniform distribution of active drugs in the MDIs/DPIs/NSPs/Nebulizers of a batch. The same test for Nasal Spray (NSP) is called Spray Content Uniformity (SCU) which is also performed within a batch. The test checks the active drug content of a number of MDIs/DPIs/NSPs/Nebulizers from a batch. For Example, 10 MDI units are randomly collected from a lot. Then the 10 MDIs are actuated in 10 different collection tubes to collect the doses. These 10 collection tubes containing the actuated doses are then assayed to measure the active drug content. The result of this assay helps to identify if there is any unapproved variation in active drug contents in the tested MDI products. It also helps to compare the drug content uniformity among batch-to-batch.


BIO-XIN provides Dosage Unit Sampling Apparatus (DUSA) for both Dose Content Uniformity (DCU) and Spray Content Uniformity (SCU). This dose collection apparatus is an arrangement of adapters, vacuum pump, flow meter, waste shot collector and collection tubes. We provide DUSA for MDI, DPI and Nebulizers. Our Spray Content Uniformity (SCU) sampling apparatus for NSP is a one and only robotic system of the world supplied from USA.