Medicine safety and quality are the governing principles of the pharmaceutical industry. Thanks to our many years’ analytical experience and innovative range of equipment, we provide you with reliable, efficient support with your analytical and microbiological quality control. We offer you analytical inspections of pharmaceutical raw materials, in-process controls, finished medicinal products and also packaging materials, using the technologies of chromatography and spectroscopy, with a focus on the following:
- Mineral analysis for specification checking, release tests or stability studies,
- Vitamin analysis for specification checking, release tests or stability studies,
- Elemental analysis for testing for metallic impurities in medicines, raw materials, active ingredients, additives and primary packaging material, and also for implementing the ‘ICH Q3D Guideline for Elemental Impurities’.
- Pesticide residue analysis of raw materials and finished medicinal products, for examination of the residue situation and legal conformity,
- Inspection of raw materials and finished medicinal products for contamination by pyrrolizidine alkaloids and toxins, such as aflatoxins B and G and ochtatoxin A, for examination of the residue situation and legal conformity,
- Inspections in accordance with the European Pharmacopoeia.
We also carry out the following microbiological analyses of pharmaceutical raw materials and finished medicine products:
- Testing of microbiological purity,
- Inspection of the microbiological quality in accordance with the European Pharmacopoeia,
- as well as inspections of pharmaceutical raw material ‘water’.
Thanks to our R&D department, which is well-equipped, experienced and qualified in methodolgy development, we can also provide you with quick, flexible and individual assistance with the development, establishment and validation of analytical inspection methods. In doing so, we take into account the international standards and also take care of documentation that meets your requirements.