Type of Posting: Notice of Intent to Revise
Posting Date: 21-Jan-2022
Targeted Official Date: TBD
Expert Committee: Biologics Monographs 4-Antibiotics (BIO4)
In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that the Biologics Monographs 4-Antibiotics (BIO4) Expert Committee intends to revise the Gramicidin monograph.
Comments with supporting data were received that indicate the standard concentrations should be optimized to obtain a satisfactory concentration-response relationship. The Expert Committee proposes the following revision to the Assay Section in the monograph:
- include a statement of “Determine during method verification the median concentration (S3), starting with the concentration suggested in Table 7, to obtain the optimum concentration-response relationship”.
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.
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