Unknown Impurities Identification Projects
Frontage has a unique skill set from various chemistry disciplines and equipment to efficiently elucidate the structures of unknown compounds found in APIs and finished products during stability evaluations. We employ a systematic approach for identification and isolation of these compounds, allowing for projects to be quickly and successfully completed.
The workflow for identification projects involves the following steps:
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Evaluate the HPLC conditions used to measure the compound to ensure complete separation of the compound from other close-eluting entities. This is an important step to determine whether fraction collection techniques can be used to isolate quantities of the unknown for further structure determination experiments.
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Develop LC/MS/MS-friendly chromatography that can separate the unknown entity and verify the elution of the unknown via spiking studies.
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Employ the organic chemistry group to isolate larger quantities of the unknown using flash or preparative chromatography.
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Utilize LC/MS/MS, NMR and/or Maldi-TOF equipment to perform structure elucidation experiments.
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Synthesize the predicted compound, identified from the MS and NMR measurements and confirm that the synthetic material elutes as observed during the unknown entity measurements.
