Product and substance performance

One aspect of product quality is its in vitro performance that can be evaluated using procedures such as dissolution, drug release, disintegration, aerodynamic particle size distribution, etc. Work in this area includes dissolution tests, which can demonstrate whether a tablet or capsule reliably dissolves as intended to deliver its active ingredient to the patient; standards for transdermal drug products, and metered dose inhalers; as well as validated tests for excipient performance.

Learn more about some of USP’s recent developments in these areas:

New Product Performance Expert Panel

  • An Expert Panel formed in 2018, New Advancements in Product Performance Testing, is working toward identifying opportunities for USP to partner with stakeholders and develop needed performance tests for a variety of drug products and delivery systems.
  • The Expert Panel is looking not only at drug products and delivery systems currently in the USP-NF, but also newer drug delivery systems such as microneedles, dermal patches, stents, etc.

Biorelevant dissolution testing

Metered Dose Inhaler (MDI)/Inhalation

Excipient performance

  • A major revision to <1059> Excipient Performance was published in PF 46(1), adding 29 new functional categories


  • A new General Chapter, <1153> Drug Products Containing Nanomaterials, will become official on May 1, 2021.