Recently a question has been asked that while conducting PVT (Performance Verification Test), only the basket apparatus met the criteria but not the paddle apparatus, is the apparatus acceptable for use if the basket is to be used for product testing?
In essence, the query relates to seeking an opinion that if such were the situation what would the response be from a standard setting body? Obviously, a clear and a definite answer can only be provided by a representative of the standard setting body. If someone would like to contribute in this regard, please submit your response to the moderator of the site.On the other hand, however, some scientific discussion is provided here which may help in reaching an objective response.
To address this query, one has to ask a question as to whether meeting the PVT criteria does indeed reflect acceptable performance of dissolution apparatuses? Unfortunately, there is no or limited scientific evidence available to support the link of meeting the PVT criteria and the actual performance of a dissolution tester. Therefore, some standard setting organizations will accept evidence of apparatuses performance based on mechanical calibration alone without requiring the PVT.
