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Fosfomycin Tromethamine

Type of Posting: Notice of Intent to Revise
Posting Date: 05-Oct-2022
Targeted Official Date: To be determined
Expert Committee: Small Molecules 1

In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that the Small Molecules 1 Expert Committee intends to revise the Fosfomycin Tromethamine monograph.

Comments were received indicating that a late eluting peak with an RRT about 7-9 in the Assay and Organic Impurities tests was an artifact peak possibly due to column bleeding. The Expert Committee intends to revise methods of the Fosfomycin Tromethamine monograph when supporting information is received. Manufacturers are encouraged to submit their validated methods to USP to modernize the methods.

It is anticipated that the proposed revision will be published as an In-Process Revision in a future Pharmacopeial Forum pursuant to the Rules and Procedures of the Council of Experts.

Should you have any questions, please contact Devarshi Narendra Thaker, Scientific Liaison (