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).
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.
Currently important: Content determination of pyrrolizidine alkaloids (PA)
Certain plants produce pyrrolizidine alkaloids in order to ward off predators. PA are water soluble and can therefore be transmitted via soil water to plants that do not contain PA themselves. For humans degradation products of these phytochemicals are hepatotoxic and therefore harmful. Because of this toxicity and the derived new legal limits a content determination of PA in plant extracts, foods, raw materials and intermediates for homeopathic medicines is essential.
We offer the analysis of pyrrolizidine alkaloids and their N-oxides. We use SPE-LC-MS / MS based on the BfR-standard BfR PA Tea 2.0/2014.
Extractables and 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 toleranceAn 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)
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.