Techniques for chemical and physical testing

  • UHPLCs with UV and PDA/DAD detectors
  • HPLCs with UV, PDA/DAD and RI detectors
  • GC with head space, FID-detector
  •  AAS
  • FT-infrared spectrometer, FT-IR
  • Spectrophotometer
  • Polarimeter
  • Titrators
  • In-vitro dissolution
  • Disintegration tester
  • Friability tester

Chemical analyses

Following comprehensive chemical analyses belong to our analytical service portfolio.

  • Method development, validation and transfer for various analytical techniques with full documentation
  • Development and validation of analytical methods for cleaning validation
  • Comprehensive quality control analytics of drug substances, excipients and finished products
  • Re-analysis of pharmaceutical products for the EU market
  • Batch certification by QP
  • Continuous follow-up stability testing for products on the market
  • Consultant and scientific documentation services of analytics

Analytics for inhalation drug products

In our humidity- and temperature-controlled GMP certified laboratory we perform analytics for inhalation drug products. We have experience on analytics of inhalation drug products both DPIs (dry powder inhalers) and MDIs (metered-dose inhalers). For specific testing condition we have enclosure system (17-35°C, 17-85%RH). Our typical analytical services for inhalation drug products are followings.

  • Determination of aerodynamic particle size with multiple impactors according to Pharmacopoeias. Specific techniques for inhalation drug products:
    • Next Generation Impactor (NGI)
    • Multi-stage liquid impinger (MSLI)
    • Andersen cascade impactor (ACI)
  • Delivered dose uniformity
  • Inhaler testing data analysis by CITDAS software
  • Method development, validation, transfer
  • Other standard tests of inhalation products
  • Microbiological tests

Full analytical package for stability studies
Stability studies

Analytics for process validation
Technology transfers and industrialisation