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.

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/UPLC.
  • Method for active substance determination in “in vitro” permeation studies.
  • Enantiomeric purity methods.
  • Analysis of trace elements in surfaces (machines cleaning).
  • Analytical method transfer.

Analytical support for the formulation development

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

Finished product characterization studies

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

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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