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!
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 – 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. Wenbo Wang
Dr. Anna Shevchenko
Borman PJ, Chatfield MJ, Damjanov I, Jackson P (2011) Method ruggedness studies incorporating a risk-based approach: A tutorial, Anal Chim Acta 703(2):101-113.
Vogt FG, Kord AS (2011) Development of quality-by-design analytical methods. J Pharm Sci 100(3):797-812.