Type of Posting: Notice of Intent to Revise
Targeted Official Date: 01-Jan-2021, Interim Revision Announcement
Expert Committee: Biologics Monographs 2-Proteins (BIO2)
In accordance with section 7.04(c) of the 2015–2020 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 Filgrastim monograph.
The BIO2 EC is proposing a revision to the Filgrastim monograph to specify the use of three new reference standards, one for the physical chemical tests (USP Filgrastim System Suitability RS), one for the Assay (USP Filgrastim for Bioassay), and one for the Limit of High Molecular Weight Proteins (USP High Molecular Weight Filgrastim). At present, USP Filgrastim RS supports all monograph tests. However, USP is developing new reference standards for use with this monograph to provide specific testing advantages. The new reference standard, USP Filgrastim for Bioassay RS, is formulated specifically to support the assay, requiring less dilution. The new reference standard, USP High Molecular Weight Filgrastim RS contains a defined amount of high molecular weight species of Filgrastim and is used for peak identification.
It is anticipated that the proposed revision will be published in PF 46(4) [Jul.-Aug. 1, 2020].
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