Our services
Whether you’re in need of detailed particle size analysis, navigating the complexities of impurities, or requiring thorough stability testing, Eurofins CDMO is your partner in achieving exceptional quality and regulatory compliance.
Advanced Analytical Techniques
At Eurofins CDMO, we pride ourselves on our cutting-edge analytical capabilities. Our laboratory is outfitted with the latest technology to perform a wide array of precise analyses for analytical development and validation. Our services include:
- Forced Degradation Studies: We conduct detailed and tailor-made studies to evaluate the stability of drug products under Assay-Purity Testing: utilizing (Ultra) High-Performance Liquid Chromatography ((U)HPLC) combined with Mass Spectrometry (MS). In addition to learn and understand the potential degradation pathways of your drug product, these forced degradation studies are also a first step in optimizing the (U)HPLC purity method
- As a part of Forced Degradation studies, we conduct Photostability studies to assess the impact of light exposure on drug products
- (Ultra) High Performance Liquid Chromatography ((U)HPLC): with these workhorses we have direct in-house support for our Formulation Development and offer unmatched accuracy and precision in quantifying the purity of your drug products
- Dissolution Testing: Our comprehensive dissolution testing services are designed to meticulously assess the release profiles of drug products across different media, whether it handles about immediate release, sustained release, or controlled release
- Particle Size Distribution Analysis: We ensure consistency and quality in drug formulations by precisely analyzing particle size distribution
- Water Content Analysis: Employing Karl Fischer titration, we measure the water content to safeguard product stability and efficacy
- Extensive Characterization: With tools such as Fourier Transform Infrared Spectroscopy (FTIR), we delve into the physicochemical properties of drug substances and products, offering deep insights into their characteristics
- Excipient Compatibility Studies: To ensure drug formulations maintain their integrity and efficacy
- Advanced Solubility and Permeability Testing: Utilizing PION MicroFLUX equipment to provide essential data for drug formulation and bioavailability
Shelf-life Prediction & Safety
Our laboratories are at the forefront of conducting in-depth stability and excipient compatibility studies. These critical analyses, including Accelerated and ICH Stability Studies across various climatic zones, are pivotal in predicting the shelf-life and ensuring the safety and efficacy of drug products.
In addition to conventional real-time stability studies, we can also predict the long term stability by means of mathematical accelerated stability assessment tools applied on short term incubations at elevated temperatures and humidity conditions.
Discover how our specialized drug product analytical services can advance your pharmaceutical development and quality control processes.
R&D pre-validation and transfer to GMP QC for validation
When all methods in scope are developed and optimized, then these are subjected to an R&D pre-validation. This R&D pre-validation has several intentions:
- Demonstrating confidence in the methods for further usage in the R&D environment (e.g. for R&D accelerated stability studies)
- De-risking and facilitating the transfer of methods from our R&D entity to our GMP QC entity for subsequent validation, release and stability testing activities in a GMP environment, ensuring timelines are kept
"We can easily switch between small and large molecules"
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