As per a recent follow-up note from USP (link), it is stated that “It is known that the dissolution of USP Prednisone Tablets RS changes over time.” Is this a good thing?
In principle, if the tablets, or anything else, are not stable then by default these should not be used as a REFERENCE. How would their use as a REFERENCE be justified?
On the other hand, the new validity/expiry date has been extended for six months to December 31th, 2015. Will the characteristics of the tablets change gradually or will they change abruptly on December 31, 2015? If the changes in dissolution characteristics are gradual, then shouldn’t the Ranges be changed more frequently such as weekly, bi-weekly, or monthly etc.?
Some thoughts for consideration!
