Re:How a British Covid-19 vaccine went from pole position to...
by refurb on Saturday December 26, 2020 @11:42PM
(#25548904)
UV visible does have all those benefits you mention. What went wrong here is what is called “validation” and is a big part of pharmaceutical analytical analysis.
You not only describe how you measured your drug concentration, but you also test the limits. And those limits should go beyond anything you might encounter in actual manufacturing.
If your aim is to confirm a concentration of 5mg/mL, then you test all the way down to 0mg/mL and then 50mg and 500mg/mL. Then if you have a saline mixture, you test different concentrations of NaCl.
You’re basically trying to break the analysis to show where it doesn’t work.
The fact they did a UV vis and didn’t account for a different emulsifier is a big miss.
You not only describe how you measured your drug concentration, but you also test the limits. And those limits should go beyond anything you might encounter in actual manufacturing.
If your aim is to confirm a concentration of 5mg/mL, then you test all the way down to 0mg/mL and then 50mg and 500mg/mL. Then if you have a saline mixture, you test different concentrations of NaCl.
You’re basically trying to break the analysis to show where it doesn’t work.
The fact they did a UV vis and didn’t account for a different emulsifier is a big miss.