Impurity Isolation & Purification

Isolation of impurities may be required for a variety of reasons, such as structure elucidation, generation of materials for use as reference standards and separation of racemic mixtures into enantiomers.

Toref utilizes state-of-the-art chromatographic techniques to isolate your unknown impurity or trace impurity in drug substances or drug products. Tools such as Preparative HPLC, SFC, Flash Chromatography, and preparative TLC are employed in the isolation and purification of compounds and low-level impurities.

Features of Isolation & Purification Services at Toref

  • Toref can provide the isolation of a large number of impurities, enabling quantitative and qualitative analysis of impurities.
  • Toref is equipped with a variety of analytical instruments and equipment, which can develop suitable methods for impurity standards with different chemical properties to achieve the appropriate detection limit in order to achieve the purpose of methodology and analytical detection.
  • Toref has a number of drug analysis technology platforms, familiar with drug impurity analysis, drug declaration and other relevant regulations, efficient collaborative technical service capabilities.

Efficient Isolation

    • Skilled inisolation of impurities ,such as low content (≤ 0.1%)samples, unstable (significantly degraded within 1 hour at room temperature) , poor resolution,weak chromatographic retention or no UV absorption of highly difficult trace components
    • mg-scale, g-scale, kg-scalepurification available
    • StructureDetermination, provide complete information, COA and other relevant inspection data to meet the declaration requirements
    • Providing Isolation & Purification and structural analysisFor multi-component crude
    • Proficient in the preparation and Isolation technology of chiral compounds.

Further Information

For more information about our processes or isolation and purification services in general, get in touch with our pharmacutical impurity isolation and structure elucidation team.