Impurity Profiling and Synthesis of Standards

Impurity profiling is a critical point in drug development. Their analysis and identification, as well as the synthesis of impurity standards appearing in drug substances and drug products is a key activity in which Enantia has more than 20 years of experience in.

Our impurity services include:

  • Impurity characterization and identification: Underpinned by Enantia’s profound knowledge of reactivity mechanisms, along with the use of advanced analytical techniques, we are able to elucidate the most challenging unknown impurities appearing either in drug substances and in formulated drugs.
  • Impurity isolation through enrichment and tandem MPLC / HPLC purification.
  • Impurity formation studies through stress tests and excipient compatibility studies.
  • Preparation of impurity reference standards from milligram to gram scale for analytical method development, qualification and toxicological studies.
  • Nitrosamine analysis and preparation of their standards.
  • Carry-over studies: detection, identification and quantification of impurities and their potential transformations during the chemical synthesis. This includes synthesis and isolation of impurities, purge and spiking experiments.  
Analytical equipment and vials to perform impurity profiling. HPLC and GC are used for the identification of impurities and impurity standards that are prepared at Enantia.
Flash chromatography used at Enantia for impurity profiling and synthesis of standards. This equipment helps with the isolation and purification of impurities, to further identify them. It is also helpful in reference standard preparation.

Enantia offers a comprehensive approach to impurity profiling, identifying impurities in starting materials and those formed throughout the development process. By using HPLC/MS and NMR as primary techniques, we characterize impurities and assess their impact on the final compound’s quality. Additionally, and when necessary, high-resolution MS/MS provides deeper structural insights.

We also conduct spiking and purge studies as part of our Process Development services in order to confirm impurity formation, transformation, and carry-over, ensuring robust control strategies for both innovative and generic drug development.