Content uniformity specification for tablets typically requires the active ingredient to lie within what range of the labeled value?

• A. 85-115%
• B. 90-110%
• C. 70-130%
• D. 80-120%

Answer: (A)

Content uniformity checks ensure each tablet contains roughly the same amount of active ingredient. For tablets, the standard expectation is that the amount in an individual unit falls within 85% to 115% of the labeled amount. This window accounts for normal manufacturing variability while keeping dosing within a safe and effective range. A narrower range like 90-110% is typically used for strict potency assays, but for unit-to-unit uniformity the 85-115% criterion is the common benchmark. The other ranges would either be too permissive or too strict given typical production variability, making 85-115% the best fit for this concept.