Distek, Inc. Announces USP Tablet
Changes
Contact:
Distek, Inc.
Jeff Seely
888-234-7835 Phone
732-422-7310 Fax
info@distekinc.com
North Brunswick, NJ - January 27, 2010
There has been a lot of
discussion and speculation about the USP Prednisone tablets, the testing of
those tablets, and the role of Salicylic Acid in validating USP 1 and 2
dissolution apparatus in recent months. As of December 1, 2009, the USP
dropped the Salicylic Acid test from its requirement for the Performance
Verification Test (PVT). They had let it be known prior to this that there
were also changes coming for the Prednisone test.
On January 19, 2010, the USP
released further word that they will release a new lot of Prednisone tablets
(lot # P1I300) on or about March 1, 2010. It further stated that the
current lot of Prednisone tablets (lot # POE203) would still be acceptable
for use in PVTs until April 30, 2010.
The most significant change
known at this time with the new lot of Prednisone tablets is the way in
which a dissolution tester’s (USP 1 and 2) performance is determined. The
USP will require evaluation of the performance using geometric mean and
%CV. In the past, the % Dissolved was determined for each individual tablet
and it simply had to be within the assigned range. With the new lot, the
geometric mean and %CV results will determine the suitability of the
dissolution tester. The USP has not yet released the certificate for the
new lot so what the requirements will be are not known at this time. From
about March 1, 2010 to April 30, 2010, either lot of Prednisone would be
acceptable for use in PVTs, but they must be run as instructed on the USP
reference standard certificate assigned to the lot being used.
The USP has not yet determined
when or if the availability of Salicylic Acid tablets will be discontinued.
Some labs have continued to run them as part of their periodic PVT and have
not yet revised their procedures for taking the Salicylic Acid tablets out
of their testing procedures. Salicylic Acid tablets (lot # QOD200) will be
available for the foreseeable future. As stated earlier, they are not
required but they are available.
Distek has offered a PQ for
the USP 1 and 2 apparatus for many years. The PQ is a validated method of
the PVT. It offers testing procedures for both Salicylic Acid and
Prednisone. We are currently still executing this protocol and will
continue to do so through the end of April 2010. We have not eliminated the
Salicylic Acid tests from the protocol since there are many customers who
still require that test be performed. Most laboratories have already
eliminated the Salicylic Acid tests from their requirements and our
personnel simply cross off the Salicylic Acid portions of the protocol and
designate them as “N/A.”
Distek is currently developing
a new protocol to use the new lot of Prednisone tablets. This procedure and
protocol cannot be finalized until it is determined exactly how the tablets
are to be run in the dissolution tester. It is assumed, but not confirmed,
that the operating parameters will be the same as the past lots. This would
mean that the stirring speed would be 50 RPMs, the vessel volume 500ml, and
the sample time 30 minutes. Distek is also developing a spread sheet for
calculation of the geometric mean and %CV results. This will be based on
the % Dissolved results from each vessel. Distek anticipates that this new
validation protocol will be released within a few days of the new Prednisone
lot being released. If the information is made public before then, Distek
expects to release the new protocol document at that time. This will allow
our customers to review and approve the new testing method before we execute
it.
This notice will be updated as new
information becomes available. If there are any questions, please feel free
to contact Distek directly.
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