Preparative HPLC services at SIELC support compound purification, impurity isolation, and reliable analytical-to-preparative scale-up.
SIELC’s preparative HPLC capabilities encompass a broad range of proprietary reversed-phase, normal-phase, HILIC, and mixed-mode preparative columns (up to 50 mm ID) designed to isolate compounds in the 5–1000 mg range. All columns are manufactured in-house and undergo strict quality control. Each column is tested and shipped with an original chromatogram, ensuring reproducibility and compliance with specifications. We have supplied these columns to many satisfied customers worldwide. The preparative infrastructure includes HPLC pumps capable of up to 200 mL/min, manual and automated injection devices, variable wavelength, refractive index and MS detectors, as well as fraction collection equipment. All stationary phases are bonded at our facility, allowing close monitoring of batch quality. Our preparative HPLC services are used worldwide for research purification and pharmaceutical development.
The preparation of ultra-clean chemical entities and reference standards requires detailed analytical method development using all possible HPLC modes. This is followed by scaling up using preparative columns packed with the same stationary phases. Target compounds are obtained through optimized sample loading, followed by concentration and thorough analysis using suitable analytical HPLC methods. A similar approach is applied to the separation of isomers of diverse chemical nature, with isomer ratios in purified fractions provided to the customer. We also work with materials supplied by the customer and can adapt methods to specific client samples and project requirements. These preparative HPLC services are designed for reliable research purification and pharmaceutical workflows.
Isolation of impurities from potential drug candidates and/or their synthetic intermediates is a standard process typically conducted at early stages of drug development. This is essential for the initial assessment of structure and biological activity of possible impurities. These impurities are generally isolated using preparative HPLC methods derived either from client-supplied analytical data or methods developed by SIELC. The target range is approximately 5–10 mg of impurity, which is usually sufficient for structure determination by LCMS and NMR. When required, these research preparative methods can be scaled up to obtain larger quantities for initial toxicology studies. SIELC preparative HPLC services enable controlled impurity isolation and method scale-up.
A research project based on preparative HPLC begins with evaluation of existing analytical data for the client’s sample. If resolution is insufficient, additional analytical methodology is developed. Optimal separation conditions are then scaled up on an appropriate preparative column, impurities are collected and concentrated, and final purity assessment is performed using both SIELC and client analytical methods to ensure consistency with prior data. Thanks to the broad selection of stationary phases and column dimensions, scale-up is predictable and reliable.
Learn more about our analytical HPLC columns.
Please contact us at mail@sielc.com to discuss projects where SIELC can assist. Our facilities include preparative HPLC instrumentation and all necessary equipment for concentrating collected fractions. We strictly adhere to all terms and conditions, including security measures, in accordance with NDA agreements with our customers.
