Type of Posting: Notice of Adoption of Harmonized Standard
Posting Date: 25–Feb–2011 (updated 27–Feb–2017*)
Official Date: 01–Dec–2011
Expert Committee: Monographs—Excipients
*Coordinating Pharmacopeia: EP
A harmonized standard for Crospovidone 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 Crospovidone monograph has been formally approved by the USP Monographs—Excipients Expert Committee in accordance with the Rules and Procedures of the 2010–2015 Council of Experts.
Changes from the existing USP–NF monograph include:
- Changed Definition from Anhydrous basis to Dried Basis. Amended to include Type A or Type B, determined by particle size.
- Added tests for Identification C and D. Added new test to distinguish between Type A and Type B using wet sieving.
- Changed Assay acceptance criteria from anhydrous basis to dried basis.
- Changed Residue on Ignition specification from 0.4% to 0.1%.
- Added Peroxides test.
- Changed Vinylpyrrolidinone test from titration to HPLC.
- Deleted pH test.
- Replaced Water Determination test with Loss on Drying.
- Updated significant figures in Water-Soluble Substances Acceptance criteria from 1.50 to 1.5%.
- Added Labeling requirement that the label states as Type A or Type B.
The Crospovidone monograph will be incorporated into and become official with the Second Supplement to USP 34–NF 29.
*Should you have any questions about the Crospovidone monograph, please contact Dr. Tong (Jenny) Liu (240-221-2072 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: