News

Application Note: Automated Karl Fischer Moisture Determination in Lyophilised Drug & Vaccine Products

We have produced a new application note focused around moisture determination in lyophilised drug and vaccine products utilising the Aquafast automated moisture analyser from a1-envirosciences GmbH.

Lyophilisation

Lyophilisation is a common step in drug and vaccine product manufacturing to improve stability of the formulation. Optimisation of the lyophilisation cycle for each formulation/fill combination includes assessment of the residual moisture level of the lyophilised cake.

Aquafast

The Aquafast Automated moisture analyser from a1- envirosciencs GmbH consists of a Nittoseiko (formerly Mitsubishi) coulometer and Gilson GX-271.

Conclusion

An automated coulometric Karl Fischer titration method was developed to address moisture determination in hygroscopic lyophilised biological materials. Advantages include:

  • Process is more environmentally friendly
  • Many more samples can be tested before the KF cell must be cleaned
  • Multiple samples could be processed unattended after dispensing of the dry solid
  • Applicable to difficult samples which would foul the KF and make manual testing impossible

To read more about automated Karl Fischer moisture determination in lyophilised drug & vaccine products and receive a copy of the full application note, email sales@a1-envirosciences.co.uk.