Lipid nanoparticles (LNPs) became famous for the rapid development and largescale production of vaccines during the COVID-19 pandemic. Theses vaccines consist of mRNA coding for an antigen encapsulated in LNPs. Because the mRNA is sensitive to inactivation by distinctive oxidation products of the lipids, special care in quality control of the formulations and raw materials is required. Here, we suggest a workflow for HPLC-MS/MS detection of lipid related impurities in LNP formulations, independent of impurity standards.
Overlay of XIC of quantifier transitions for lipids of the vaccine BNT162b2.
Workflow for the selection of transitions for lipid impurities. A: Expected impurity, known from literature review [3,4]. B: Chromatogram of the parent lipid ALC-0315, detected in ESI+, Q1MI mode with Q1 mass = 782.7. Three peaks were found for the monito
| Method | LC-MS |
|---|
| Flow rate | 0.4 ml/min |
|---|---|
| Mode | RP |
| Injection volume | 2µL |
| Substances | Cholesterol, DSPC, ALC-0315, ALC-0159, ALC-0315 N-oxide |
| Key words | LC-MS, LNP, lipids, impurities, purity, N-oxide |
| CAS number | 57-88-5, 816-94-4, 2036272-55-4, 1849616-42-7 |
AZURA® P 8.1L UHPLC pump with a maximum delivery pressure of up to 124 MPa/1240 bar for ultra-fast and high-resolution applications
Article No.: APF45PA
Show product
AZURA® Autosampler AS 6.1L analytical HPLC autosampler, 1240 bar, with sample cooling/heating
Article No.: AAA11AA
Show product
Column thermostat AZURA CT 2.1 for constant temperatures and reproducible results
Article No.: ATC00
Show product
The SCIEX Triple Quad™ 4500 MS/MS System provides superior quantitative performance, excellent robustness, and long-term stability, enabling to develop tests for even the most demanding applications.
Article No.: A66450
Show product
ClarityChrom® single instrument license for one time base
Article No.: A1670
Show productWe are happy to help you
