Development and validation of analytical research methods
Development of measuring methods for analysis of raw materials, by-products and finished product – is the essential need for any company performing control of its product quality on every stage of production, from product development to its release, as well as ensuring stability of its characteristic throughout the whole shelf-life.
Verification and validation of method of the analysis is the process directed at confirmation of suitability of analytical procedure, used for particular measuring, for its designed usage. The results of method validation can be used for confirmation of quality of measurements, reliability and concordance of the results of analysis.
Validation or re-validation of analytical methods of measuring takes place in the following cases:
- prior to method’s introduction for daily usage;
- in case of changes of any of the conditions or parameters of method validation (for example, if measuring equipment with different characteristics or samples with different matrix are used);
- If changes introduced into the method transcend the limits of primary area of method application.
The Novations company specializes in and offers services of development and validation of methods of analysis, base upon the following physico-chemical methods of measuring:
- Particle size analysis by laser diffraction (particle size distribution)
- Nanoparticle size analysis bydynamic light scattering (DLS, photonic correlation spectroscopy)
- Particle size and shape analysis by optical microscopy with application of morphological visualization and analysis of digital images (Morphological Imaging Analysis)
- Particle size and shape analysis byscanning electronic microscopy
- Analysis of stability of suspensions and emulsions by electrophoretic light scattering (DLS, determination of zeta potential)
- Determination of molecular weight by static light scattering (SLS)
- Determination of particle size and concentration in liquids by light obscuration
- Morphological and elemental analysis of surfaces by scanning electronic microscopy method, using energy dispersing X-ray spectroscopy
- Development and validation of methods based upon Raman and IR spectroscopy (input raw materials and finished product identification, quantitative analysis of components)