Method Development

Are you always sure that the analytical (standard) method can give you adequate results when ordering individual analysis? 

The optimisation of a method during the manufacturing process development is frequently needed to fit the systematically chosen Quality-By-Design (QbD). 

Did you know that  

  • Most standard methods have exceptions¬†
  • Frequently material properties impact the results¬† or even make a method irrelevant¬†
  • It saves time and money to adopt standard methods to fit each case¬†

Particle analytical has +20 years of expertise in method adoption and development! 

More Information 

This is an example of a method development process: 

  • Setting the¬†aim¬†of the method¬†
  • Searching for the optimal analytical parameters to achieve the goal¬†
  • Study the properties of the material¬†‚Äď we define the package in collaboration with you¬†
  • Finding¬†the optimal measurement parameters, i.e.¬†measurement time per step, equilibration conditions, pre-drying time, dispersion media and time etc.¬†
  • Comparing the method under development with the existing methods¬†
  • Evaluating the critical method variables¬†
  • Evaluation of method robustness¬†
  • Building strategy of risk mitigation¬†

Example of possible Method Development Strategy. The Scheme adopted from Vogt FG, Kord AS (2011).   

Consult our Experts

 

Dr. Changyong Lu
QC Chemist


Dr. Anna Shevchenko
Principal Scientist

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