Determining trace amounts and the origin of formaldehyde impurity in Neisseria meningitidis A/C/Y/W-135-DT conjugate vaccine formulated in isotonic aqueous 1× PBS by improved C18-UPLC method

- We determined traces of formaldehyde in a vaccine formulated in 1× PBS.
- Also determined formaldehyde in in-process materials.
- UPLC C-18 column resolved formaldehyde addition product from reagent.
- Unique sample preparation for liquid vaccine has been presented.
- This method helped to track-down formaldehyde process contamination source.