Is there any reason why a HPLC assay method with good validation parameters (linearity, precision and accuracy) between 70 and 130% of the target concentration should not be used for content uniformity without modifications?
P.S.: As long as the same concentration can be obtained in both cases with a volumetric flask of adequate capacity, naturally...
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By Anonymous on Monday, April 24, 2000 - 10:03 am:
The sample solvent for the assay may not be able to dissolve the tablet.
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