Analytical Services
With our many years of expertise, we can assist you with your analytical projects and questions. From method development to stability studies as well as feasibility studies and analytical releases for clinical studies, we offer you a comprehensive portfolio of services. On this page, you will find an overview of our offerings.
Analytical method development and method validation
Analytical method development and method validation
We offer the development, validation and transfer of qualified analytical methods for all phases of your product - based on common Pharmacopoeias Ph. Eur., USP, JP and ICH-guidelines
- Determination of assay / purity
- Drug release
- Determination of residual solvents
- Adhesion properties
- IR-spectroscopy
- Determination of water content
- etc.
Quality control testing and release testing
Quality control testing and release testing
Tests are performed according to all important Pharmacopoeias and internal established methods:
- Implementation and optimization of customer specific analytical methods
- Release of starting materials, intermediate and finished products
- Investigation of primary and secondary packaging
- Routine analysis for pharmaceutical products
Stability storage and stability testing
Method indicating stability - studies in accordance with ICH principles
Stability testing according to ICH Q1A are one of our core competencies. We cover all necessary climatic conditions or temperatures.
- Ongoing and follow-up-stability studies for drug registration
- Narcotic drugs storage and testing
- Stress testing
Our equipment
Our equipment
We have high-quality state-of-the-art equipment under full GMP conditions. This includes, for example, HPLC systems with various detection options, GC-FID with liquid and headspace autosampler, disintegration testing for fast-dissolving dosage forms, Karl-Fischer titration, dissolution testing (apperatus 1,2,5,6), etc.
Planar dosage forms analytics
Planar dosage forms analytics
We are experts in specialized analytic methods for patch and oral film drug delivery systems:
In-vitro studies:
- Human skin (dermal systems)
- Different mucous membranes (mucosal systems)
- Synthetic membranes
Physical studies, e.g.:
- Tensile testing
- Strength flexibility