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Systematic error associated with apparatus 2 of the USP dissolution test V: Interaction of two tableted prednisone
Abstract:
Recently marketed glass vessels that are uniform and pass USP specifications were compared with uniform plastic vessels that also pass USP specifications. Two lots of prednisone tablets, Tablet 1 and Tablet 2, were tested in both types of vessels. Tablet 1 gave higher results (+12.7% of label claim) in glass vessels at 50 rpm but gave equivalent results in either vessel at 75 rpm. Tablet 2 gave equivalent results in either vessel at 50 rpm but gave higher results (+22% of label claim) in glass vessels at 75 rpm. The type of vessel used to obtain dissolution results for tablets should be specified.
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