3,5,9-Trioxa-4-phosphaheptacosan-1-aminium, 4-hydroxy-N,N,N-trimethyl-10-oxo-7-[(1-oxooctadecyl)oxy]-, inner salt, 4-oxide, (7R)-;
1,2-Distearoyl-3-sn-phosphatidylcholine. [816-94-4]
BRIEFING
1,2-Distearoyl-sn-glycero-3-phosphocholine. Because there is no existing NF monograph for this excipient, a new monograph based on validated methods of analysis is proposed. During the pandemic, mRNA-lipid nanoparticle COVID-19 vaccines were developed and approved for emergency use by the FDA. One of the key lipid components, 1,2-Distearoyl-sn-glycero-3-phosphocholine, plays a crucial role to form the lipid nanoparticle to protect the mRNA, which translated into proteins to fight against the virus. 1,2-Distearoyl-sn-glycero-3-phosphocholine has been published in FDA’s Global Substance Registration System (G-SRS) and CDER Inactive Ingredient Database (IID). USP has identified this as a top priority component to establish the standard as a new monograph.
The monograph title 1,2-Distearoyl-sn-glycero-3-phosphocholine was approved by the USP Nomenclature and Label Expert Committee. The name is consistent with the G-SRS database and IID. The following are highlights of the proposed tests in this new monograph:
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The fatty acid composition gas chromatography (GC) method for Identity by Fatty Acid Composition as well as the HPLC method in the Assay are added as identification tests. The validated GC method is based on analyses using the Agilent CP-Wax 52 CB brand of column with G16 phase. The typical retention times for methyl myristate, methyl stearate, and methyl oleate are about 22.4, 30.4, and 30.8 min, respectively.
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The Assay test is based on a validated HPLC method performed using the MilloporeSigma LiChrospher Diol-100 brand of column with L20 packing. The typical retention time for 1,2-distearoyl-sn-glycero-3-phosphocholine is about 8.1 min.
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The Organic Impurities test of 1-stearoyl-sn-glycero-3-phosphocholine, stearic acid, and total unidentified impurities were analyzed by a validated HPLC method using the Phenomenex Kinetex C18 brand of column with L1 packing. The typical retention times for 1-stearoyl-sn-glycero-3-phosphocholine, stearic acid, and 1,2-distearoyl-sn-glycero-3-phosphocholine are about 2.9, 3.9, and 9.9 min, respectively.
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The Limits of Ethanol and Acetone test is based on a validated GC headspace procedure with the Agilent brand of DB-1 column with G1 phase. The typical retention times for ethanol, acetone, and benzyl alcohol are around 1.66, 1.95, and 31.5 min, respectively.
(CE: A. Chang)
Correspondence Number—C305570