Your trusted partner for analytical excellence, from particle sizing to impurity profiling and stability testing.
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.
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). These forced degradation studies are also a first step in optimizing the (U)HPLC purity method and understanding the potential degradation pathways of your drug product.
To assess the impact of light exposure on drug products.
We have direct in-house support for our formulation development and offer unmatched accuracy and precision in quantifying the purity of your drug products.
Our comprehensive dissolution testing services are designed to meticulously assess the release profiles of drug products across different media, to assess the release profiles of drug products intended for immediate release, sustained release or controlled release, across different media.
We ensure consistency and quality in drug formulations by precisely analyzing particle size distribution.
Employing Karl Fischer titration, we measure the water content to safeguard product stability and efficacy.
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.
To ensure drug formulations maintain their integrity and efficacy.
Utilizing PION MicroFLUX equipment to provide essential data for drug formulation and bioavailability.
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 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 specialised drug product analytical services can advance your pharmaceutical development and quality control processes.
When all methods in scope are developed and optimised, they are then subjected to R&D pre-validation. This R&D pre-validation has several intentions: to demonstrate confidence in the methods for further usage in the R&D environment and to de-risk and facilitate the transfer of methods to the GMP QC entity, ensuring timelines are met for subsequent validation, release, and stability testing activities in a GMP environment.
