July 15, 2015
This statement is being provided as a follow-up to the Notice to Customer letter dated July
10, 2015. The mentioned letter was sent to notify customers of the revised Valid Use Date of
USP Prednisone Tablets Reference Standard catalog #1559505 lot R001B0.
It is known that the dissolution of USP Prednisone Tablets RS changes over time. The
scientific process used to establish and monitor the ranges has also been documented in the
scientific literature. Please see the link to the article below.
http://www.dissolutiontech.com/DTresour/201302Articles/DT201302_A01.pdf
This is taken into consideration when establishing the acceptance ranges of each lot and this
approach has been applied to lot R001B0. At the time of release (September 3, 2014) the
available data was used to predict the lot’s stability trend and the validity period for the
acceptance limits was established on the basis of that data and the Valid Use Date of lot
R001B0 was set at August 31, 2015. Recently, statistical analysis of data from routinely
conducted studies showed that the projected performance, based on the trend, had shifted.
The projected performance indicates that the limits given on the Certificate for lot R001B0
are no longer suitable for use after July 6, 2015. For this reason, the Valid Use Date was
moved up.
Performance Verification Testing performed using Lot R001B0 up to and including July 6,
2015 can be used to demonstrate conformance to Performance Verification Test (PVT) limits
published in the USP certificate for lot R001B0. Lot R001B1 was released and available for
sale as of July 14, 2015 with a Valid Use Date of December 31, 2015.
Please do not hesitate to contact your USP account manager or [email protected] if you have
any further questions.