In addition to our FAST routine analysis program, we offer a wide variety of advanced characterization methods and high level problem solving for your difficult drug substance or drug product samples. We can help with a host of development issues including identification of crystalline phases in active pharmaceutical ingredient (API) and drug product, quantification of crystalline or amorphous content, identification of phase separation in dispersion samples, investigation of salt or co-crystal disproportionation, solvate/hydrate determination and characterization, form changes during stability testing, and many more.
Many solid form changes occur upon processing, including API crystallization, isolation, and drying as well as formulation processing. Let us help you identify any form changes during your processing stream that may affect the dissolution or performance of your dosage form.
Our techniques include high level analysis using common solid-state techniques (XRPD, DSC, TG, IR, Raman, hot stage microscopy) along with advanced solid-state NMR spectroscopy, chemical imaging (infrared [IR], Raman, energy dispersive x-ray [EDX]). We can develop quantitative methods for API or drug product samples for early or late development projects. A variety of methods are available to investigate the relaxation and stability of amorphous materials and amorphous solid dispersions.
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