Polysorbate 80 and histidine quantitative analysis by NMR in the presence of virus-like particles.
HPV
NMR
histidine
polysorbate-80
stainless steel
vaccine
Journal
Electrophoresis
ISSN: 1522-2683
Titre abrégé: Electrophoresis
Pays: Germany
ID NLM: 8204476
Informations de publication
Date de publication:
07 2022
07 2022
Historique:
revised:
28
02
2022
received:
21
06
2021
accepted:
22
03
2022
pubmed:
3
4
2022
medline:
16
7
2022
entrez:
2
4
2022
Statut:
ppublish
Résumé
Polysorbate-80 (PS80) and histidine are common excipients in vaccine and therapeutic protein formulation. A simple quantitative NMR method to measure both PS80 and histidine in human papillomavirus (HPV) virus-like particle (VLP) vaccine for aqueous and alum-containing samples is described. The new NMR method is compared to current colorimetric methods for PS80 and RP HPLC for histidine. The new NMR method is comparable to current assays with an advantage of a simpler sample treatment for PS80. The efficiency is also increased because one method can now provide two assay results instead of two separate methods. Furthermore, the NMR method can detect PS80 stability due to hydrolysis and oxidation when PS80 is stored in a stainless steel container by observing a change of its NMR line shape profile.
Identifiants
pubmed: 35366009
doi: 10.1002/elps.202100189
pmc: PMC9544792
doi:
Substances chimiques
Excipients
0
Polysorbates
0
Histidine
4QD397987E
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1408-1414Informations de copyright
© 2022 Merck Sharp & Dohme Corp. Electrophoresis published by Wiley-VCH GmbH.
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