Analytical Development

Our analytical development services encompass the following activities:

Raw material characterization studies

  • • Solubility studies in different media (organic, aqueous and different PH levels).
  • • Characterization of the thermal profile and identification of polymorphic forms by DSC.
  • • Impurities profile characterization.
  • • Raw material standardization.
  • • Forced degradation studies ("stress testing") of active substances.
  • • Development of analytical methods for the API (richness, degradation products and residual solvents).
  • • ICH stability studies for API.

Finished product characterization studies

  • • Full analytical characterization of products selected as a reference product.

 Analytical support for the formulation development

  • • Search for discriminative dissolution media.
  • • Profiles analytics and chemical pre-stability by HPLC.

 Development and validation of analytical methods of finished products

  • • Assay method, uniformity of content and preservatives (by spectrophotometry, chromatography and potentiometry).
  • • Related substances method (liquid, gas or ion chromatography).
  • • Water content determination method.
  • • Residual solvent method.
  • • Dissolution method by UV and HPLC.
  • • Method for active substance determination in "in vitro" permeation studies.
  • • Enantiomeric purity methods.
  • • Analysis of trace elements in surfaces control (machines cleaning).
  • • Methods for determination of extractables and lixiviates.
  • • Analytical method transfer

 Comparative in vitro dissolution tests

  • • Comparative studies of dissolution profiles versus the reference product in ICH media.

 In vitro permeation studies

  • • Permeability analytical study in Franz diffusion cells.

 Manufacturing process and cleaning control

  • • Validation and control of cleaning methods and manufacturing process.
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