Vibration effects of lab equipment on dissolution testing with USP paddle method.
Environmental vibration induced by laboratory equipment, building construction, or even by the analysts themselves is one of the more complicated factors affecting dissolution testing. It is difficult to control and/or calibrate by mechanical means or performance-based methods. In this study, dissolution apparatus vibration levels were measured in the frequency range from 10 to 270 Hz along all three axes using commercially available, single-axis accelerometers. The vibration distribution on the dissolution vessel plate was mapped, and acceleration was subsequently measured during dissolution runs involving NCDA#2 (10 mg prednisone) tablets using the paddle method. Several types of laboratory equipment were used to induce vibration during dissolution testing and vibration levels along the X-, Y-, and Z-axes of the vessel plate were measured in an attempt to establish possible correlation with dissolution results. In the frequency range studied, root mean square (RMS) acceleration values above 0.01 g, in either vertical or horizontal direction, typically affected dissolution results.
Gao
Zongming
Z
Food and Drug Administration, Center for Drug Evaluation and Research, Division of Pharmaceutical Analysis, St Louis, Missouri 63101, USA. zongming.gao@fda.hhs.gov
Thies
Andrea
A
Doub
William
W
D000054:Acceleration; D002626:Chemistry, Pharmaceutical / Q000295:instrumentation*; D004864:Equipment and Supplies / Q000592:standards; D010602:Pharmacopoeias as Topic; D011241:Prednisone / Q000032:analysis / Q000737:chemistry / Q000592:standards; D012984:Software; D012995:Solubility; D013607:Tablets / Q000032:analysis / Q000737:chemistry* / Q000592:standards; D014732:Vibration
D013607:Tablets; D011241:Prednisone