title: Development of a performance verification test for USP apparatus 4.
abstract: OBJECTIVE
  To evaluate salicylic acid tablets as a candidate reference material in a Performance Verification Test (PVT) when a USP performance test for dissolution (General Chapter <711>) relies on USP Apparatus 4 (flow-through cell).
  
  
  METHODS
  We developed a dissolution procedure relying on Apparatus 4 and salicylic acid tablets. Thereafter, a designed experiment was conducted to identify operational variables that significantly affect salicylic acid dissolution in this apparatus.
  
  
  RESULTS
  Four variables (size of glass beads, cell temperature, flow rate, level of deaeration) and one combination effect (deaeration/bead size) were significant for mean percent dissolved. Two variables (tablet orientation, level of deaeration) were significant for standard deviation results, but these effects were less pronounced than those for mean percent dissolved results. Three variables (analyst, tester manufacturer, amount of glass beads) had no statistically significant effects on either the mean or standard deviation of the responses.
  
  
  CONCLUSIONS
  The proposed PVT is capable of probing effects of changes in several critical operational parameters of Apparatus 4. Salicylic acid tablets were shown to be a suitable reference material for the PVT. The PVT using salicylic acid tablets satisfies important aspects of a PVT.
authors.affiliation: US Pharmacopeial Convention, 12601 Twinbrook Parkway, Rockville, Maryland, 20852-1790, USA. jwe@usp.org
authors.forename: Joseph W
authors.initials: JW
authors.lastname: Eaton
authors.forename: Daren
authors.initials: D
authors.lastname: Tran
authors.forename: Walter W
authors.initials: WW
authors.lastname: Hauck
authors.forename: Erika S
authors.initials: ES
authors.lastname: Stippler
mesh_terms: D000890:Anti-Infective Agents / Q000737:chemistry*; D020156:Salicylic Acid / Q000737:chemistry*; D012995:Solubility; D013607:Tablets / Q000737:chemistry*; D013678:Technology, Pharmaceutical / Q000295:instrumentation / Q000379:methods*
chemical_list: D000890:Anti-Infective Agents; D013607:Tablets; D020156:Salicylic Acid