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  • 1 Quinta Analytica
  • 1 Quinta Analytica
  • 1 Quinta Analytica
  • 1 Quinta Analytica

Analytical Research and Development

 

Development of analytical methods

Development and testing of new analytical methods represents our primary activity. Most frequently, we are asked for a new method development for the following reasons:

  • it is necessary to monitor reaction conversions and impurity levels in intermediates during the development of a new synthetic route of an active pharmaceutical ingredient (API)
  • Assay or purity method described in a corresponding pharmacopoeia is obsolete or does not comply with customer's requirements
  • The analytical method for purity or assay of API in a new drug product is simply not available
  • A final drug product represents a novel combination of APIs
  • No analytical method exists for determination of the particular auxiliary chemical of impurity

HPLC or UPLC techniques can be used in most of the mentioned cases. Our laboratory is equipped with Alliance 2690/5 (Waters) and Agilent 1000 (Agilent Technologies) HPLC chromatographs and Acquity UPLC system (Waters). All systems are used predominantly with DAD-UV detection.

If the classical HPLC/UV method appeared to be non-selective or insensitive (e.g. in trace analysis) we employ our modern LC/MS system consisting of Alliance 2695 separation module (Waters) and a linear ion trap MS detector LTQ ( Thermo-Finnigan).

In some cases, particularly when analytes cannot be detected on UV, you may find that a TLC technique is the most suitable. Exactly for this type of situation we use our TLC station Camag, consisting of an automated sampling unit Linomat 4, development chamber and colour CCD digital camera compartment  Reprostar 3.

When a development of method for determination of volatile analytes is required, we may use a GC/FID or GC/MS. Both techniques could be coupled to classical liquid injection (with PTV option) or to a static headspace injection. For both we possess a GC chromatograph 7890A/5975C (Agilent Technologies) with CombiPAL (CTC Analytics) autosampler.

For highly polar organic substances or inorganic ions we are equipped with a multifunctional ion chromatograph ICS3000 (Dionex) using a conductivity and/or amperometric detection cell.

Beside the mentioned methods, we provide and coordinate a development of methods for particle size distribution by microscope with image analysis or laser diffraction (MasterSizer 2000, Malvern Instruments), titration methods predominantly with pontentiometric detection (Titrino-Metrohm), dissolution methods (Varian, Hanson) with UV or HPLC detection, and more.