Dissolution test acceptance sampling plans.
The U.S. Pharmacopeia (USP) general monograph provides a standard for dissolution compliance with the requirements as stated in the individual USP monograph for a tablet or capsule dosage form. The acceptance rules recommended by USP have important roles in the quality control process. The USP rules and their modifications are often used as an industrial lot release sampling plan, where a lot is accepted when the tablets or capsules sampled are accepted as proof of compliance with the requirement. In this paper, the operating characteristics of the USP acceptance rules are reviewed and compared to a selected modification. The operating characteristics curves show that the USP acceptance rules are sensitive to the true mean dissolution and do not reject a lot or batch that has a large percentage of tablets that dissolve with less than the dissolution specification.
Tsong
Y
Y
Division of Biometrics, U.S. Food and Drug Administration, Rockville, Maryland 20857, USA.
Hammerstrom
T
T
Lin
K
K
Ong
T E
TE
D002214:Capsules / Q000592:standards*; D010602:Pharmacopoeias as Topic; D012494:Sampling Studies; D012995:Solubility; D013607:Tablets / Q000592:standards*; D014481:United States
D002214:Capsules; D013607:Tablets