SIELC’s preparative HPLC capabilities encompass a broad range of proprietary reversed-phase, normal phase, HILIC, and mixed-mode preparative separation columns (up to 50 mm ID) designed to target compounds in the 5-1000 mg range. The preparative instrumentation includes HPLC pumps with up to 200 mL/min capabilities, manual and automated injection devices, variable wavelength, refraction index and MS detectors, and fraction collection equipment.
The preparation of ultra-clean chemical entities and reference standards requires detailed analytical method development using all possible modes of HPLC. This is followed by scaling up using preparative columns packed with the same stationary phases. Target compounds are obtained through optimized sample loads and then concentrated, followed by a thorough analysis using suitable analytical HPLC methods. A similar approach is applied for separating isomers of diverse chemical nature, with the determination of isomer ratios in the pure isomers provided to the customer.
Isolation of impurities from potential drug candidates and/or their synthetic intermediates is a standard process typically conducted at the early stages of drug development. This is crucial for the initial assessment of the structure and biological activities of potential impurities. Generally, these impurities are isolated using preparative HPLC methods, which are derived either from client-supplied analytical HPLC data or methods developed by SIELC. The target range for such preparations is approximately 5-10 mg of the impurity, which is usually sufficient for structure determination using LCMS and NMR methods. Scaling up these research preparative HPLC methods is possible for obtaining larger quantities needed for initial toxicology experiments.
A research project based on the use of preparative HPLC technology starts with the evaluation of any existing analytical HPLC data for the client’s sample. Additional analytical methodology will be developed in case of inadequate resolution of the impurities of interest from the main component of the sample. Optimal separation conditions will then be scaled up on an appropriate preparative column, impurities collected and concentrated. Final purity assessment will be carried out using SIELC and client’s analytical methods to match the results with previous data.
Please feel free to contact us at prep@sielc.com to discuss any projects where SIELC can be of help. Our capabilities include preparative HPLC instrumentation and all necessary equipment for concentrating the generated fractions. We strictly adhere to all terms and conditions, including security measures, as per the NDA agreements with our customers.
