BRIEFING

 Hydrogenated Soybean Phospholipids. Because there is no existing NF monograph for this excipient, a new monograph based on validated methods of analysis is proposed. Many new lipid-based formulations require more purified, well-characterized phospholipids to enhance drug release and delivery. To meet the stakeholders' needs, and as part of its iterative approach to developing excipient standards, USP has introduced several phospholipid monographs in addition to the existing Lecithin and Egg Phospholipids monographs to cover both natural phospholipids and synthetic phospholipids, including Soybean Phospholipids and Soybean Phosphatidylcholine, covering highly pure and ultrapure grades of soybean lecithin, respectively. The Lecithin monograph applies to various lecithin products derived from crude vegetable oil sources, including soybean, sunflower, and canola. However, the Lecithin monograph is not intended for use in injectable dosage forms. USP continues to engage stakeholders in updating the Lecithin monograph to help clarify the scope of products it currently covers. For ultrapure and highly pure grades from other sources, USP is actively seeking stakeholder collaboration to develop individual monographs. Additionally, new monographs for 1,2-Distearoyl-sn-glycero-3-phosphocholine and Sodium N-(Carbonyl-Methoxypolyethylene Glycol 2000)-1,2-Distearoyl-sn-Glycero-3-Phosphoethanolamine [PF 51(4)] were recently introduced into USP–NF.

 To continue this effort, USP is developing two new monographs, Hydrogenated Soybean Phospholipids and Hydrogenated Soybean Phosphatidylcholine, which are published in this PF. USP also collaborates with the FDA in its efforts to establish nomenclature titles, preferred names in the FDA’s Global Substance Registration System (GSRS), and the article names in the Inactive Ingredient Database (IID). Through these efforts, the monograph title, Hydrogenated Soybean Phospholipids, was approved by the USP Nomenclature and Labeling Expert Committee. The following are highlights of the proposed definition and tests in this new monograph:

 

1. Hydrogenated Soybean Phospholipids is defined to contain NLT 60.0% and NMT 89.9% of hydrogenated phosphatidylcholine, calculated on the anhydrous basis, obtained from the soybean source. It may contain suitable stabilizers.

2. Identity by Fatty Acid Composition employs a validated gas chromatographic (GC) method of analysis performed using the Agilent CP-Wax 52 CB brand of column with G16 phase. The typical retention times for methyl palmitate, methyl stearate, and methyl oleate are about 26.8, 30.7, and 31.0 min, respectively.

3. The Assay is based on a validated HPLC method performed using the Merck KgaA Lichrospher 100 Diol brand of column with L20 packing. The typical retention times for phosphatidylethanolamine, hydrogenated phosphatidylcholine, and hydrogenated lysophosphatidylcholine are about 6.6, 7.5, and 9.8 min, respectively.

4. The Impurities tests, Free Fatty Acids by High-Performance Thin-Layer Chromatography, and Triglycerides by High-Performance Thin-Layer Chromatography are added to quantify these two impurities. The amount of triglycerides and free fatty acids should be NMT 3.0% and NMT 0.5%, respectively.

 (EXC1: A. Chang)

 Case ID—SUB-304