Evaluation of Glass Dissolution Vessel Dimensions and Irregularities

Perturbation Study of Dissolution Apparatus Variables—A Design of Experiment Approach

“…Equivalently, the combination effect of deaeration was more important at the 25-mm height than at 23 mm, and the difference between replacement and manufacturer's vessels was more pronounced at 23 mm than 25 mm. Although these data may not be conclusive enough to warrant a tighter specification for paddle height, they do show that paddle height should be closely monitored (16). The height should be checked in conjunction with the vessel that will be used for the dissolution test using a gauge calibrated to be accurate.…”

“…However, recent research has shown that geometric irregularities are found in dissolution vessels and affect dissolution results using USP Prednisone RS Tablets (11,15). The two sets of vessels used in this study were similar in their geometric properties as measured using a 3-dimensional coordinate measuring machine (16). The replacement vessels were set arbitrarily to the high (+1) value for the Design of Experiment study, not, however, because we believe them to be of inferior quality.…”

Establishing Acceptance Limits for Dissolution Performance Verification of USP Apparatus 1 and 2 Using USP Prednisone Tablets Reference Standard Lot Q0H398

“…Because of the similarities in formulation, manufacturing process, and dissolution behavior of lots Q0 and P1, Q0 tablets are expected to be as sensitive to the operational parameters as P1 (2,5,6,(9)(10)(11). We see the similarity of the two Lots in Figure 3, where the data are similar, and in Table 3, where we see that the acceptance limits are similar.…”

“…PVT with USP Prednisone Tablets RS, in conjunction with mechanical calibration, is a valuable tool in maintaining proper dissolution apparatus performance (7,8). PVT helps ensure that appropriate measures are taken to control the following sources of significant variability in dissolution testing: dissolved gasses, vibration, vessel dimensions, analyst, and analytical procedure (9)(10)(11)(12). The PVT also addresses sources of variability that are unknown (4).…”

Overview of Dissolution Instrument Qualification, Including Common Pitfalls

“…While it is recognized that there are (22,23). The USP Prednisone Tablets RS for PVT have also shown dissolution rate and variability differences among vessel manufacturers (24).…”