Formaldehyde has been used in the inactivation of a number of viral and bacterial toxins used in vaccines. In some cases, a small amount of formaldehyde in the final vaccine`s formulation may be necessary in order to prevent reversion back to the antigen toxic state during storage Inactivation Residuals are one of the important components to be controlled in vaccines. The purpose of this research is to determine the residual formaldehyde present in two locally marketed vaccines. A selective (GC-FID) has been developed and validated. The methods has been found to be simple, sensitive, reliable and reproducible for the quantitation of formaldehyde. The limit of Gas chromatography with Flame Ionization Detector detection was calculated to be 0.6 μg\mL. Limit of quantification was 2 μg\mL. Correlation factor was 0.9993 and the percentage recovery was calculated and the value was 99.4%.
So this method has been successfully applied on vaccines to determination of formaldehyde residual amount , The results were satisfactory so it doesn't exceed the labeling amount.
Homs University Journal.
2020.
Development of A GC-FID Method for Determination of FA in two locally marketed vaccines.