Impurity isolation & sample purification
Unknown impurities can arise at all stages of the pharmaceutical R&D lifecycle, from drug discovery through to commercialisation. Identifying and eliminating these impurities is essential to help protect patient safety. RSSL’s expertise in isolating and identifying impurities enables us to play a key role in helping you to research, develop and manufacture high quality pharmaceutical products.
Our expert scientists use a wide range of state-of-the-art techniques to isolate, purify, and characterise pharmaceutical impurities at trace levels, even in complex matrices. Preparative scale isolation is first carried out using chromatographic techniques and post-purification treatment, such as freeze drying. Advanced spectroscopic techniques can then be employed to identify the impurities of interest.
Once the impurity has been identified, we also offer further scale-up for the isolation of larger quantities of impurities for use as reference materials. This combination of orthogonal techniques ensures the highest possible purity and accurate characterisation of isolated compounds.
RSSL supports the development and scale up of sample purification methods, ensuring reproducible and efficient purification approaches tailored to your specific API's.
Our comprehensive suite of analytical techniques includes
Whether you’re facing unexpected peaks, troubleshooting a formulation issue or preparing for a regulatory submission, our impurity isolation and purification services can help you move forward with confidence.
