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Analytical development

TECNALIA offers a wide spectrum of services under contract, such as; formulation and analytical development, scaling and manufacture of pilot batches, quality control and batch release, stability studies, pharmacogenetics, clinical trials from phase I to IV and manufacturing to third parties.

The Pharmaceutical Development Laboratory of TECNALIA is authorized by the Spanish Agency for Medicines and Health Products (AEMPS) in Standards of Correct Manufacturing (NCF).

 

 Analytical Development_TECNALIA_1_2

SERVICES IN ANALYTICAL DEVELOPMENT

  • Studies Development and validation of analytical techniques.
  • Characterization of raw materials according to the Pharmacopoeia.
  • Quantification of active principles, impurities and degradation products in raw materials and finished products.
  • Studies of forced degradation.
  • Quality control of industrial manufacturing batches.
  • In-vitro dissolution profiles.
  • Study of the discriminative power of the means of dissolution.
  • Transfer of analytical techniques.
  • Analysis of metallic impurities by ICP-OES.

FACILITIES AND EQUIPMENT

TECNALIA has more than 3,000 M2 of laboratories for the pharmaceutical industry. Our Laboratory of Pharmaceutical Development in Analytical Development has:

Chromatography:

HPLC (12 units)

  • Agilent Technologies HPLC 1260 infinityII Prime Series (1 unit)
  • HPLC Waters Acquity HCLASS Series (1 unit)
  • Binary UPLC Waters (1 unit)

Dissolvent:

Total of 6 dissolution baths (2 of them double)

  • Agilent 708-DS (2 units)
  • Erweka DT 1614 (2 double units)
  • Sotax AT-7 (2 units)
  • Fraction collector Erweka FLR 724-2 (2 units)

Other equipment:

  • Analytical and humidity balances
  • Durometer
  • Friability tester
  • Disintegrator
  • Biological safety cabinet
  • Differential scanning calorimetry (DSC)
  • Rheometer
  • Viscometer
  • Osmometer

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Parque Científico y Tecnológico de Bizkaia. Astondo Bidea, Edificio 700. E-48160 Derio. Bizkaia (Spain). Tel.: 902.760.000 - International Calls: (+34) 946.430.850


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