bTablets lubricated with 0.5% magnesium stearate and prepared on rotary machines to a target crushing strength of 60 N (6.1 kgf)
cNot available
on chemical parity and because it has not been possible to standardize performance criteria. With the exception of dissolution, the tests of purity and identity described in pharmacopoeia are generally very limited to their relevance to characterizing materials relative to their formulation functionality.
The literature is replete with examples demonstrating functional differences in excipients that depend on the particular material and circumstance. Control of functionality is as important as control of identity and purity. The following reasons can be cited:
1. Many excipients have multiple functions.
2. There is lack of awareness in some situations that the excipients behave differently, depending upon the vendor (or even from lot-to-lot), so much so that substitution from one source to that of another is not possible.
