Revision of USP Chapter <1094> Capsules - Dissolution Testing And Related Quality Attributes Published for Comments

In the Pharmacopeial Forum, PF 48(4), a new version of USP Chapter <1094> Capsules—Dissolution Testing And Related Quality Attributes was published.

The chapter provides approaches for the development of dissolution test procedures for capsules. It also discusses quality attributes associated with capsules that may affect the outcome of dissolution testing.

Based on comments received on the version of the chapter official as of December 1, 2020, several revisions are being proposed. These include:

  • References to USP chapter <1711> (Oral Dosage Forms—Performance Tests) and to FDA guidance on dissolution testing (Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances) were inserted
  • The following four subchapters have been added:
    - 4.1 Cleaning Considerations
    - 5.6 In vitro in vivo Correlations
    - 6.3 Brittleness
    - 6.4 Overall Potential Capsule Defect Assessment.
  • Additional information, recommendations and examples have been added to various sections of the document.

In addition, minor editorial changes have been made.

Further information and a more detailed summary of the proposed revisions can be found in the document published on PF Online. The deadline for submitting comments is 30 September 2022.

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