Type of Posting: Notice of Adoption of Harmonized Standard
Posting Date: 25–Feb–2011 (updated 25-Feb-2017*)
Official Date: 01–Dec–2011
Expert Committee: General Chapters—Dosage Forms
*Coordinating Pharmacopeia: USP
Harmonized standard for Uniformity of Dosage Units 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 Uniformity of Dosage Units 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:
- Removed condition that allows hard capsules, uncoated tablets, and film coated tablets not meeting the 25 mg/25% requirement to be tested by the Weight variation procedure based on RSD of API concentration per dosage unit demonstrated in validation or development data. This change represents USP-specific national text and will not appear in the EP and JP.
- Added Content Uniformity procedure and criteria for semi solid dosage forms, and instructions to assay 10 units.
The <905> Uniformity of Dosage Units General Chapter was incorporated into and became official with the Second Supplement to USP 34–NF 29.
Should you have any questions about this 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 Cover pages and Stage 6 postings are included as below:
- Download the Uniformity of Dosage Units
- Download the Uniformity of Dosage Units Cover Pages:
- Previous Stage 6 posting in PF 35 (3), 2009
- Previous Stage 6 posting in PF 32 (6), 2006 (IRA)
- Previous Stage 6 posting in PF 31 (6), 2005 (IRA)
- Previous Stage 6 posting in PF 30 (4), 2004