ANALYTICAL SERVICES

We offer comprehensive chemical and microbiological services. The continuous development of our laboratories with a goal of full electronic data handling to ensure the integrity of analytical raw data will enable us to comply with the latest regulatory requirements. This together with constant investments in the laboratory techniques and facilities make certain that we can meet client needs.

You can make a request for analysis here.

Quality control services

We have over 30 years analytics experience in accordance with EP, USP and JP pharmacopoeias, and quality control analysis of drug products. Our service portfolio includes:

  • Comprehensive quality control analytics of drug substances, finished products, excipients, packaging materials, and water samples 
  • Re-analysis of pharmaceutical products for the EU market
  • Batch certification by QP

Inhalation analytics

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

  • 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

Method development & validation

Our method development and validation team brings years of experience in approaches approved by both ICH and FDA guidelines. This service can be performed separately or as a part of formulation development project.  Our service portfolio includes

  • Method development, validation and transfer for various analytical techniques with full documentation
  • Development and validation of analytical methods for cleaning validation
  • Risk based verification tests for pharmacopoeia methods

Microbiological services

Our GMP certified microbiological laboratories provide large scale of analysis and also proficient consultancy services for microbiological challenges. Microbiological analyses are performed according to the current Pharmacopoeias.

  • Determination of the total aerobic microbial count and the amount of yeast or mould (TAMC /TYMC)
  • Examination of water for pharmaceutical purposes
  • Testing for specified microorganisms
  • Efficacy of antimicrobial preservation
  • Validation of test methods in the presence of the product with complete documentation
  • Growth promotion testing of microbiological culture media
  • Comprehensive testing of biological indicators: such as efficacy of sterilization, and population assays
  • Working area hygiene controls
  • Microbiological assay of antibiotics

Equipment

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 with flame atomiser
  • FT-IR
  • Spectrophotometer
  • Polarimeter
  • Titrators
  • In-vitro dissolution
  • Disintegration tester
  • Friability tester

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