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Nutritional CRO & test laboratory

Testing product quality and tolerance

High quality and confidence in your products ensure the lasting success of your company.

Valid statements about the quality and safety of your products are becoming increasingly important – also as a result of increasing legal requirements. We assess raw materials, intermediate and finished products for you according to current quality standards (FCC, Ph. Eur., USP, AOAC, DAB and validated methods).

Analysis methods:

Chemical-physical test

  • Identity checks
  • Purity tests
  • Content tests
  • Stability tests

e.g. of vitamins, secondary plant substances such as pyrrolizidine alkaloids and sum parameters. For a detailed selection of analysis possibilities please get in touch with Dr. Roland Wacker.

Contaminants (Extractables & Leachables)

Unwanted contaminants from processed materials of medical devices may leak through contact with the body or skin and enter the human body. Such potentially migrating components include plasticizer or adhesive and ink ingredients. But not only the processed materials for medical devices are sources of such leachables and extractables. Inks, packaging materials or intermediates of the production process can offer a source of harm to humans: depending on the load, risk potential and purpose these contaminants significant health risks emanate. In accordance with the applicable health and safety requirements medical devices manufacturers must detect possible contaminants of its form and quantity and prove their tolerance

An example of plasticizers are phthalates, which occur in a variety of products. Our laboratory provides analysis of the most common phthalates such as:

  • DIDP (di-isodecyl phthalate)
  • DINP (diisononyl phthalate)
  • DEHP (di (2-ethylhexyl) phthalate)
  • DBP (dibutyl phthalate)
  • BBP (benzyl butyl phthalate)

The exact target parameters of an investigation are always dependent on the to be examined product and its specific use. Therefore, they are set according to the customer specifications.

Similar problems exist in the field of food packaging. The used polymers, adhesives, inks can also contaminate products if found in significant concentrations. If you have further questions, don’t hesitate to contact us.

Enzyme activity studies

To determine enzyme activities, recognised and internationally accepted standards must be used. We guarantee you strict compliance with these standards and traceable control of environmental conditions, incubation variables and measurement technology.

Example tests:

  • Acidic lactase activity (FCC)
  • Neutral lactase activity (FCC)
  • Arylsulfatase activity (customer method)
  • Total protease activity/pankreatin (Ph. Eur.)

Antioxidative status

As a result of too high concentrations of reactive oxygen species in the body, oxidative stress can cause degenerative damages. The body therefore protects itself using antioxidants. Our portfolio includes the determination of relevant parameter in both physiological matrices and in your product (e.g. food, beverages, extracts, cosmetics):

  • ORAC assay (hydrophilic and lipophilic) of products
  • TEAC test
  • Vitamin status in blood plasma or oral mucosa cells
  • Malondialdehyde in blood plasma/serum
  • Glutathione in whole blood or oral mucosa cells
  • Coenzyme Q10
  • Vitamins C, A, B1, B2, B6
  • Tocopheroles/tocotrienoles
  • Carotenoids
  • Parabens in products