Type of Posting: Notice of Intent to Revise
Posting Date: 28-Mar-2025
Targeted Official Date: 01-Jul-2025, Revision Bulletin
Expert Committee: Biologics Monographs 2-Proteins (BIO2)
In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that the Biologics Monographs 2-Proteins (BIO2) Expert Committee intends to revise the Somatropin and Somatropin for Injection monographs.
The requirement to heat the USP Somatropin Reference Standard for the System Suitability Solution of the Assay test could vary to achieve the dimer content of 1%-2% for different lots of the Reference Standard. To address the lot-to-lot variability, the Expert Committee intends to revise the preparation of the System Suitability Solution in the Assay test of both monographs, and to include additional handling instructions on the Reference Standards certificate.
In the description of the System suitability solution in the Assay, the the Expert Committee intends to revise the preparation instructions from stating “Place 1 vial of USP Somatropin RS in an oven at 50° for 12–24 h. Remove from the oven, and dissolve the contents of the vial in Diluent to obtain a solution with a known concentration of about 1 mg/mL and a dimer content of 1%–2%” to “About 1 mg/mL of USP Somatropin RS in Diluent with a dimer concentration of about 1%–2%. See USP Somatropin RS certificate for handling instructions.”
It is anticipated that the proposed revisions will be published as a Revision Bulletin pursuant to the Rules and Procedures of the Council of Experts on June 27, 2025 and would become official on July 1, 2025.
Should you have any questions, please contact Rebecca Potts, Senior Scientist II (rcp@usp.org).