Draft of USP Chapter <711> Dissolution (PDG harmonized document) Published for Comments

Recommendation

27/28 June 2023
Heidelberg, Germany

Dissolution Testing
Development / Quality Control and in vivo Relevance

In the Pharmacopeial Forum, PF 49(3), a proposal of a revised USP General Chapter <711> Dissolution has been published for comments. The background to the publication is the efforts of international harmonization of monographs and general analytical methods of the European, Japanese, and United States pharmacopeias.

The Pharmacopoeial Discussion Group (PDG)

The Pharmacopoeial Discussion Group (PDG), which was created in 1989, brings together

• the Japanese Pharmacopoeia (JP),
• the European Pharmacopoeia (Ph. Eur.),
• and the United States Pharmacopeia (USP).

The PDG works on pharmacopoeial harmonization of excipient monographs and general chapters.

Revised USP Chapter <711> Dissolution

The now published proposal is based on the version of the USP chapter official since 01 May 2023. It represents the official inquiry stage 2A of Revision 5 to the PDG harmonized document.

According to the briefing notes, the draft includes changes in the following sections:

• "Apparatus, Apparatus 1 (basket apparatus)
• Apparatus 3 (Reciprocating Cylinder)
• Apparatus 4 (Flow-Through Cell)
• Apparatus 4 (Flow-Through Cell), Apparatus Suitability
• Procedure, Apparatus 1 and Apparatus 2, Immediate-Release Dosage Forms
• Procedure, Apparatus 1 and Apparatus 2, Delayed-Release Dosage Forms
• Procedure, Apparatus 3 (reciprocating cylinder), Immediate-Release Dosage Forms, Extended-Release Dosage Forms, and Delayed-Release Dosage Forms
• Procedure, Apparatus 4 (Flow-through Cell), Immediate-Release Dosage Forms, Extended-Release Dosage Forms, and Delayed-Release Dosage Forms
• Interpretation, Immediate-Release Dosage Forms, Acceptance Table 1
• Interpretation, Extended-Release Dosage Forms, Acceptance Table 2
• Interpretation, Delayed-Release Dosage Forms, Acid Stage, Acceptance Table 3, and Buffer Stage, Acceptance Table 4"

The draft of the revised chapter is available on PF Online. The comment period is open from now on until 31 July 2023.