What Problems Does One Introduce When Different Criteria for Acceptability of Unfinished Actives vs. the Formulated Actives are Utilized?

Abstract

The particular topic that I am going to cover is entitled, “What problems does one introduce when different criteria for acceptability of unfinished actives vs. the formulated actives are utilized”. That is, we are aware that when one uses a different test or analytical procedure for testing and releasing an active component as a raw material as compared to testing and releasing the active component in a dosage form one may introduce a number of difficulties. Quite often the problem that arises because of these difficulties is not immediately apparent and may cause a great deal of consternation. Very often the data appears to be implausable.