Impurity & Cold Label Standards
At Cascade Chemistry, we provide the services of isolation, identification, characterization, and synthesis of process impurities, degradants, and metabolites.
Meeting FDA Standards
Our work is an essential step in meeting FDA standards. We offer services to identify, characterize, and synthesize suspected or known process impurities for structural confirmation and provide the material for use as reference standards. We can isolate compounds present at very low levels and identify them.
In many cases, the most efficient identification results from synthesizing the compound which is indicated by the mass spectrum of the HPLC peak. The synthesis then provides material for the reference standard, or marker, for the substance. The reference standards are fully characterized and issued with a Certificate of Analysis.
When Can We Start?
If you’d like to receive an estimate or discuss a project, call us at 541-484-2387 or contact us here.