BRIEFING

 Sodium Oleate 60. Because there is no existing NF monograph for this excipient, a new monograph based on validated methods of analysis is being proposed. The Assay is based on an HPLC method of analysis performed with the Infinity Lab Poroshell 120 EC-C18 or Ascentis Express C18 brand of column with L1 packing using intact sample preparation. The typical retention time for oleic acid is about 24 min. The Composition of Fatty Acids test is based on a gas chromatography method of analysis performed with the CP-Wax 52 CB brand of column with phase G16. The typical retention times for methyl myristate (C14:0), methyl palmitate (C16:0), methyl stearate (C18:0), methyl oleate (C18:1), and methyl linoleate (C18:2) are 3.8, 6.6, 11.5, 12.1, and 13.6 min, respectively.

 Applications: Sodium Oleate 60 is the sodium salt of oleic acid containing approximately 45.0%–70.0% of sodium oleate. It is widely used as a pharmaceutical excipient in lipid-based drug delivery systems, such as nano emulsions and liposomes, due to its amphiphilic nature and effective solubilizing properties.

 Monograph Development History:

 The initial 2019 PF proposal under the title "Sodium Oleate" was based on the 60% mixture-type material. Subsequent PF publications in 2021 and 2024 proposed inclusion of a 95% purified-type material and revisions to Fatty Acid Composition limits, which were presented in separate tables and analytical approaches. Ultimately, these proposals were canceled and did not become official in NF, following stakeholder feedback emphasizing the need for distinct compendial standards for different sodium oleate types.

 Current Status and Rationale: Market evaluation conducted by USP indicates that only two pharmaceutical grades—Sodium Oleate 60 and Sodium Oleate 95—are currently available. To clearly distinguish these materials, the canceled general proposal titled "Sodium Oleate" is being replaced by a product‑-specific monograph proposal for Sodium Oleate 60. In this context, the term "product" refers to an excipient product.

 Nomenclature: Sodium Oleate 60 is the USP approved title. Based on feedback received from USP, FDA has created a new UNII (B68J3WW44B) in the Global Substance Registration System (GSRS) for Sodium Oleate 60 as the preferred substance name, with appropriate synonyms and mappings. This action establishes a distinct identifier for Sodium Oleate 60 and aligns the USP approved title with the preferred substance name in GSRS.

 Stakeholder Engagement: USP has been working collaboratively with drug manufacturers using sodium oleate in FDA-approved products and with qualified material manufacturers to support the development of the Sodium Oleate 60 NF monograph. USP encourages stakeholders to contact USP if they are interested in sponsoring additional pharmaceutical-grade sodium oleate materials beyond the 60% and 95% types, to support the establishment of appropriate compendial standards.

 (EXC1: R. Challa)

 Case ID—SUB-2476