Method development and validation

Method Development and validation are among DB Lab's core competences.

Due to a background within research and development (R&D), the employees at DB Lab are used to handle challenging tasks. In the field of chemistry, we are very experienced in method development within HPLC, UPLC, GC, and LC-MS and as regards microbiology we develop methods for determination of cell count.

Whether it is raw material, API or finished product, DB Lab has the expertise to develop new methods or to uptimise existing methods supplied to us.

Examples of areas in which DB Lab has developed or optimised methods:

  • Antibiotics
  • Drug products
  • Phosphorlipids

Method validation is of course performed according to ICH guidelines. A validation study may include some of/or all the following parameters:

  • Specificity
  • Linearity
  • Accuracy
  • Precision
    • Repeatability
    • Intermediate precision
  • Detection limit/quantitation limit
  • Range
  • Robustness



Contact DB Lab for information about method development and validation.