Content Uniformity ensures that the active pharmaceutical ingredient (API) is evenly distributed in each finished dosage unit, such as a tablet or capsule.
Purpose
To confirm that each tablet or capsule contains the correct dose of the API for the patient.
When It’s Tested
After compression or encapsulation, during finished product testing.
Testing Method
Individual units are tested for API content using analytical methods like HPLC or UV spectrophotometry.
Acceptance Criteria
The result must typically fall within 85% to 115% of the label claim, with an RSD (Relative Standard Deviation) ≤ 5.0%.
Example
For a 10 mg tablet, each unit should contain between 8.5 mg and 11.5 mg of API.
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