Pharmaceutical products have the highest safety requirements.

We support you with a wide range of state of the art chemical-analytical methods. Together we ensure that your pharmaceuticals meet the highest quality requirements.

Pharmaceutical products

Pharmaceutical products must meet extremely strict quality requirements regardless of any proof of efficacy. Impurities and incorrect doses may put the health of consumers at risk. Drawing on our many years of experience and innovative laboratory apparatus, we provide reliable support for your product quality control system.

We perform analytical inspections and in-process controls of pharmaceutical raw materials, finished medicinal products, and packaging materials, with a focus on the following:

  • Mineral and vitamin analysis for specification checking, release tests or stability studies,
  • Elemental analysis for testing for metallic impurities and also for implementing the “ICH Q3D Guideline for Elemental Impurities”,
  • Pesticide residue analysis
  • Test for contamination by pyrrolizidine alkaloids and toxins, such as aflatoxins B and G, ochtatoxin A,
  • Inspections in accordance with the European Pharmacopoeia, including microbiological quality
  • Tests on the pharmaceutical raw material of “water”

Thanks to our R&D department, which is well-equipped, experienced and qualified in methodology development, we can also provide you with quick, flexible and tailored 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.

News

Nitrosamine

Frist für Nitrosamine-Risikobewertung bis März 2021 verlängert

Untersuchung Metformin-haltiger Arzneimittel auf Nitrosamine seit Oktober 2020 ...

Read more
Implementierung der ICH Q3D Leitlinie

The ICH Q3D guideline on elemental impurities in medicinal products was implemented in December 2014.

Read more

Read also

To top