title: The USP Performance Verification Test, Part II: collaborative study of USP's Lot P Prednisone Tablets.
abstract: 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.
authors.affiliation: United States Pharmacopeia, Rockville, MD 20852, USA.
authors.forename: Maria
authors.initials: M
authors.lastname: Glasgow
authors.forename: Shawn
authors.initials: S
authors.lastname: Dressman
authors.forename: William
authors.initials: W
authors.lastname: Brown
authors.forename: Thomas
authors.initials: T
authors.lastname: Foster
authors.forename: Stefan
authors.initials: S
authors.lastname: Schuber
authors.forename: Ronald G
authors.initials: RG
authors.lastname: Manning
authors.forename: Samir Z
authors.initials: SZ
authors.lastname: Wahab
authors.forename: Roger L
authors.initials: RL
authors.lastname: Williams
authors.forename: Walter W
authors.initials: WW
authors.lastname: Hauck
mesh_terms: 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
chemical_list: D013607:Tablets; D011241:Prednisone