Which statement correctly differentiates content uniformity and dosage unit uniformity?

• A. Dosage unit uniformity ensures the average drug content across multiple units meets specification.
• B. Content uniformity ensures the average drug content across multiple units meets specification within tight limits.
• C. Content uniformity requires each individual unit to meet the specification within defined acceptance criteria.
• D. Dosage unit uniformity is not defined.

Answer: (B)

The main idea being tested is how content uniformity differs from dosage unit uniformity in what they evaluate across a batch of units. Content uniformity is about the distribution of drug content across multiple units and is assessed by checking that the average content of a sample stays within tight limits around the label claim. This focus on the sample mean reflects how uniformly the drug is distributed throughout the batch.

That’s why the best statement is the one that says the average drug content across multiple units meets specification within tight limits. It captures the idea that CU cares about the mean of a group of units being close to the claimed amount and tightly controlled.

The other options either describe per-unit conformity (which is more aligned with checking individual units) or make an incorrect claim about DUU not being defined, which isn’t the case.