Pharmaceutical Polymorph Screening
Structural confirmation of crystalline active pharmaceutical ingredient (APIs) polymorphs through the application of solid state NMR, X-Ray Diffraction and other spectroscopy methods
The performance of an active pharmaceutical ingredient (API) is directly related to the molecule's specific structural form. These forms can vary with processing conditions such as temperature and the choice of recrystallizing solvent and other factors associated with the process. Our physical characterisation experts employ a suite of methods to confirm or explore the effects of these influencing factors on the crystalline phase of the API.
- Solid State Nuclear Magnetic Resonance – sensitive to chemical composition and crystalline form for a bulk API
- Raman Spectroscopy – highly localized technique for differentiation between surface and interior drugs in a delivery system (tablet or other drug delivery system)
- Powder X-ray Diffraction and Rietveld Refinement – API phase identification and quantitation with multiple phases or mixed products
- Differential Scanning Calorimetry – rapid screening protocol for mg quantities of developmental or commercial products
- Thermogravimetric Analysis, UV-VIS, Near IR and others are also available
Intertek is able to solve specific problems or provide solid state characterization services for your scale-up needs. Contact us about assembling a package of test methods for physical characterization or for problem-solving. Bringing quality and safety to life, we offer Total Quality Assurance expertise to help you to meet and exceed quality, safety and regulatory standards.
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