A 0.1% Impurity Doesn't Sound Like Much, Until it Stops Production
Catalent Pharma Solutions Can Help
- Low-level impurity isolation or enrichment
- Preparative LC capabilities (up to 100 mL/min solvent flow)
- Preparative GC for volatile components
- Impurity enrichment to facilitate identification by LC-MS or LC-NMR
- Fully documented isolation and characterization studies to demonstrate a due diligence effort to meet ICH Q3B guidelines
Isolation of sufficient quantities to allow for NMR characterization can be accomplished with impurity levels as low as 0.03%.
Catalent will:
- Evaluate the impurity by LC-MS for possible structural identification
- Determine if enrichment or isolation is needed for structural assignment
- Prepare an enriched sample through extraction, SPE or forced degradation, if needed
- Evaluate current method of analysis; further develop to facilitate isolation
- Scale up method for semi-preparative isolation
- Isolate sufficient quantities (up to mg quantities) for further characterization
Once the impurity has been isolated and characterized, our team will propose a supported structure and possible pathways for formation
Top figure shows impurity of interest, middle the modified method used for isolation with the impurity more resolved from the largest parent peak. Bottom figure show the purified impurity ready for additional characterization.
For capabilities that meet your needs, and outcomes that exceed your expectations, partner with Catalent today. For more information fill out our Contact us form or call a member of our sales staff toll-free at 866.720.3148.