Blend Uniformity focuses on the homogeneity of the API in the powder blend before it is compressed or encapsulated.
Purpose
To ensure that the API is evenly distributed in the blend to achieve consistent dosage units.
When It’s Tested
Before compression or encapsulation, as part of in-process quality control.
Testing Method
Samples are taken from different parts of the blend (e.g., top, middle, bottom) and tested for API content.
Acceptance Criteria
The result must typically fall within 90% to 110% of the target concentration, with RSD ≤ 5.0%.
Example
A powder blend for a 10 mg tablet should contain 9–11 mg of API per dose equivalent across all sampled locations.
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