Pharmaceutical analytics

In pharmaceutical development and release analysis, OFI is specialized in dealing with chemical and physical issues. Our experts support you in the development or approval of pharmaceutical products, but also in questions concerning products on the market.

 

Patient safety through sophisticated analytical methods

In order to guarantee patient safety for new drugs and medical devices, refined analysis methods are necessary. OFI accompanies and evaluates your new developments with an interdisciplinary team of experts and highly developed analytical procedures.

 

Our services (QM system: GMP)

  • Release analytics for drugs and pharmaceutical products: We accompany you from the incoming goods inspection to the batch release with qualified and state-of-the-art equipment for chemical and physical analysis. Within this framework, for example, identity, content and purity testing or conformity testing of raw materials is carried out according to the specifications of the pharmacopoeia like Ph.Eur. and USP.

  • Stability assessment studies: Determining the shelf life of APIs and pharmaceuticals is an important part of pharmaceutical development and production. We are happy to carry out stress tests for you in order to identify possible degradation products. Stability studies are very important because the active ingredients or the drug can change even under the influence of environmental influences such as temperature, humidity and light. We are also happy to conduct shelf life tests for medical devices.

  • Analysis of proteins and biopharmaceuticals

  • Method development for analytical questions: In order to guarantee the reliability of analysis results, methods must be fully validated. In this way, the identity of any substance can be quantified. Method development is not only necessary in drug analysis. Extractables and leachables studies also require method development in order to quantify additives, degradation products and impurities for the approval procedure.

  • Expert Center: Particle testing
    Clarification of unknown substances and particles: We have excellent know-how in the field of damage clarification, e.g. in the determination of unknown substances and particles. Impurities are identified and quantified.