The USP Performance Verification Test, Part II: collaborative study of USP's Lot P Prednisone Tablets.
OBJECTIVE
Periodic performance verification testing (PVT) is used by laboratories to assess and demonstrate proficiency and for other purposes as well. For dissolution, the PVT is specified in the US Pharmacopeia General Chapter Dissolution <711> under the title Apparatus Suitability Test. For Apparatus 1 and 2, USP provides two reference standard tablets for this purpose. For each new lot of these reference standards, USP conducts a collaborative study.


METHODS
For new USP Lot P Prednisone Tablets, 28 collaborating laboratories provided data. The study was conducted with three sets of tablets: Lot O open label, Lot O blinded, and Lot P blinded. The blinded Lot O data were used for apparatus suitability testing.


RESULTS
Acceptance limits were determined after dropping data due to failure of apparatus suitability, identification of data as unusual on control charts, or protocol violations.


CONCLUSIONS
Results yielded acceptance criteria of (47, 82) for Apparatus 1 and (37, 70) for Apparatus 2. Results generally were similar for Lot P compared to results from Lot O except that the average percent dissolved for Lot P is greater than for Lot O with Apparatus 2.
Glasgow
Maria
M
United States Pharmacopeia, Rockville, MD 20852, USA.
Dressman
Shawn
S
Brown
William
W
Foster
Thomas
T
Schuber
Stefan
S
Manning
Ronald G
RG
Wahab
Samir Z
SZ
Williams
Roger L
RL
Hauck
Walter W
WW
D000465:Algorithms; D002626:Chemistry, Pharmaceutical; D010602:Pharmacopoeias as Topic; D011241:Prednisone / Q000032:analysis / Q000592:standards*; D012015:Reference Standards; D015203:Reproducibility of Results; D013056:Spectrophotometry, Ultraviolet; D013607:Tablets; D014481:United States
D013607:Tablets; D011241:Prednisone