<905> Uniformity of Dosage Units

Type of Posting: 
Notice of Adoption of Harmonized Standard
Official Date: 
01–Dec–2011
Expert Committee: 
General Chapters—Dosage Forms

A 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 will be incorporated into and become official with the Second Supplement to USP 34–NF 29.

Should you have any questions about the <905> Uniformity of Dosage Units General Chapter, please contact Will Brown (301-816-8380 or web@usp.org). For any questions about the PDG and its processes, please see the Pharmacopeial Harmonization Web page or contact Mario Sindaco (301-816-8246 or mys@usp.org).