Vivian A. Gray, Bryan Crist, Brandon Maris, Harsh S. Shah, Kimberly D. Dunn, Martin Coffey, Pascal St-Laurent, Mark R. Liddell, Margareth R. C. Marques

Correspondence should be addressed to: Margareth R. C. Marques, Sr. Principal Scientist, US Pharmacopeia, 12601 Twinbrook Parkway, Rockville, MD 20852-1790; email: mrm@usp.org.

This USP guideline represents the current best practices for determining mechanical qualification performance for USP Apparatus 4, described in Dissolution 〈711〉. The guideline covers the performance qualification topics of environment, benchtop levelness, assembly, apparatus conformance, alignments, drive system and transmission, temperature control, component certification, periodic preventative maintenance, physical parameter measurement, and operational checks. This guideline is intended to provide information that aids the dissolution laboratory in establishing appropriate standard operating procedures to verify compliance with compendial requirements and ensure valid dissolution and drug release testing results.

USP welcomes proposals for a drug product that could be used as a final performance qualification to assess the overall suitability of the equipment.