Tablet Friability

Type of Posting: Notice of Adoption of Harmonized Standard
Posting Date: 30-Sep-2022
Official Date: 01-Aug-2023
Expert Committee: Dosage Form
Coordinating Pharmacopeia: United States Pharmacopeia

A revision to the harmonized standard for Tablet Friability has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Sign-Off Cover Page. Having reached Stage 4 of the PDG process, the Tablet Friability chapter has been formally approved by the USP Dosage Form Expert Committee in accordance with the Rules and Procedures of the 2020–2025 Council of Experts.

Changes from the existing USP–NF chapter include:

  1. Divide the content into three parts: Purpose, Apparatus, and Procedure.
  2. Revise the dimensional requirements for the apparatus used for tablet friability testing to a consistent format within the text and the apparatus diagram.
  3. Revise the text to clarify that the 1% recommendation for acceptable weight loss applies not only to the mean of three determinations, if necessary, but also to the results from a single determination.
  4. Other minor wording changes are also made to provide clarity to the users.

Additionally, minor editorial changes have been made to update the monograph to current USP style.

The Tablet Friability chapter will be incorporated into and become official with the USP-NF 2023 Issue 2 (August 1, 2023).

Should you have any questions about the Tablet Friability chapter, please contact Mingyan Chu (301-816-8209 or For any questions about the PDG and its processes, please contact Richard Lew at (240-221-2060 or

The previous PDG sign-offs are included as below: