Type of Posting: Notice of Intent to Revise
Posting Date: 04–Aug–2020
Targeted Official Date: 01–Sep–2020, Revision Bulletin
Expert Committee: Excipient Monographs 1 Expert Committee
In accordance with Rules and Procedures of the Council of Experts, this is to provide notice that the Excipient Monographs 1 Expert Committee intends to revise the Dextrose Excipient monograph.
Comments with supporting data received indicate that the current acceptance criteria for maltose and isomaltose and total impurities in the Related Substances test are set too tight for Dextrose Excipient available in the US market. This leads Dextrose Excipient to be out of compliance. The Expert Committee proposes to widen the acceptance criteria in the Related Substances test as follows:
- For maltose and isomaltose, change NMT 0.4% to NMT 0.6%
- For total impurities, change NMT 0.5% to NMT 0.7%
It is anticipated that the proposed revision will be published as a Revision Bulletin August 28, 2020, pursuant to the Rules and Procedures and will become official on September 1, 2020.
Should you have any questions, please contact Galina Holloway, Senior Scientific Liaison (301-816-8133 or email@example.com).