Yang G, Wang X, Yang Y, Yang R, Gowetski DB, Paula. Quantitation of residual valproic acid in flu vaccine drug substance. J Chromatogr B Analyt Technol Biomed Life Sci. 202
Quantitative measurement of process-related impurities is a critical safety requirement for the production of drug substances of vaccine and therapeutic biologics. A simple and sensitive HPLC method has been developed for separation and quantitation of residual valproic acid (VPA) used in the cell transfection procedure for the manufacturing of an influenza vaccine. The method is comprised of a modified Dole liquid phase extraction followed by a quick pre-column derivatization using 2-bromoacetophenone. Nonanoic acid (NNA) is used as the internal standard (IS) and the quantification is performed by reversed-phase liquid chromatography. This new method can accurately measure as low as 6.8 μg/mL (LOQ) residual VPA in the vaccine drug substance.
See Also:
Latest articles in those days:
- Birth cohort effects in adults associated with influenza A(H1N1)pdm09 vaccine effectiveness 5 hours ago
- Genetic Characterization of Swine Influenza Viruses in Thailand in 2019-2025 Reveals Novel Reassortants 5 hours ago
- Outbreak dynamics of high pathogenicity avian influenza virus H5N1, clade 2.3.4.4b euBB, in black-headed gulls and common terns in Germany in 2023 6 hours ago
- [preprint]The canine respiratory epithelium is a permissive ecosystem for influenza interspecies transmission and emergence 6 hours ago
- [preprint]Explainable and Calibrated AI for Decoding Host-Adaptive Changes in Influenza A Virus 6 hours ago
[Go Top] [Close Window]


