To me, this is like putting an expiration date on table salt.
To date, the only observed changes during stability testing have been the failure of some batches of KI tablets to meet the USP S1 dissolution specification, Q=75 percent in 15 minutes. Some tablets tested required slightly longer than the specified time to achieve dissolution. Even in the case of a failure of this sort, the product would remain usable. In such cases, instructions can be provided to crush the tablets and mix them with a juice or other liquid prior to administration as suggested for emergency pediatric dosing (see Home Preparation Procedures document, cited above). In any long-term stability evaluation, appearance should be monitored as a matter of course. In the specific case of KI tablets, a yellowish discoloration would be indicative of stability problems.6
Since pure KI is known to be very stable (as long as it is protected from moist air),12 ongoing evaluation and testing of each batch is probably unnecessary as long as the market package remains intact and continues to be stored under controlled conditions as described in the labeling.
Norman Cohen <ncohen12@comcast.net> wrote:
FYI
-------- Original Message --------
Subject: Draft guidance on KI Shelf Life Date: Wed, 02 Apr 2003 16:36:37 -0500 From: "Kraus, George W." <GWK@CDRH.FDA.GOV> Reply-To: "Kraus, George W." <GWK@CDRH.FDA.GOV> To: radsafe@list.vanderbilt.edu
FDA issued a new draft guidance for KI shelf life extension.
http://www.fda.gov/cder/guidance/5353dft.htm
George Kraus
FDA