Type of Posting: Notice of Adoption of Harmonized Standard
Posting Date: 25–Feb–2011
Official Date: 01–Dec–2011
Expert Committee: General Chapters—Dosage Form
*Coordinating Pharmacopeia: USP
A harmonized standard for Dissolution has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Sign–Off Cover Page. Having reached Stage 6 of the PDG process, the Dissolution General Chapter has been formally approved by the USP General Chapters—Dosage Forms Expert Committee in accordance with the Rules and Procedures of the 2010–2015 Council of Experts.
Changes from the existing USP–NF General Chapter include:
- Increased the basket screen wire diameter range in Figure 1 from 0.25–0.31 mm to 0.22–0.31 mm.
The <711> Dissolution General Chapter will be incorporated into and become official with the Second Supplement to USP 34–NF 29.
Should you have any questions about the <711> Dissolution General Chapter, please contact Will Brown (301-816-8380 or firstname.lastname@example.org). For any questions about the PDG and its processes, please see the Pharmacopeial Harmonization Group or *contact Richard Lew at (240-221-2060 or email@example.com).
*The previous PDG sign-off documents and Stage 6 postings are included as below:
- Download the Dissolution monograph
- Download the Dissolution PDG Sign-Off Cover Pages:
- Previous Stage 6 posting in PF 35 (3), 2009
- Previous Stage 6 posting in PF 33 (4), 2007 (IRA)
- Previous Stage 6 posting in PF 32 (2), 2006 (IRA)
- Previous Stage 6 posting in PF 31 (2), 2005 (IRA)
- Previous Stage 6 posting in PF 31 (1), 2005