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