USP Revises Acceptance Range
for Prednisone Calibrator Tablets

On December 21, 2000 USP revised the calibration acceptance range for USP Prednisone tablets (Dissolution Calibrator, Disintegrating type), lot M. After extensive testing by the USP laboratories, it was determined that the dissolution characteristics of Prednisone tablets, lot M had changed slightly since the product was released in 1999. The change in the dissolution characteristics caused low failures for Apparatus 2 (paddles) at 50 rpm and high failures for Apparatus 1 (baskets) at 100 rpm. USP noted that there was some evidence that the failure rate was more prevalent in newer dissolution apparatus that were not included in the original acceptance range study.
Based on USP's investigation, the following acceptance ranges were issued for USP Prednisone Calibrator tablets, lot M. These acceptance ranges are considered official as of December 21, 2000.

USP Apparatus 1 (Baskets) set at 100 rpm:
64 - 91% dissolved at 30 minutes
USP Apparatus 2 (Paddles) set at 50 rpm:
23 - 42% dissolved at 30 minutes

The updated data sheet for USP Prednisone tablets lot M is available on the USP website: www.usp.org