Drug product studies, in situ solid form characterization, formulation design, reverse engineering. Most structural changes produced in the formulation process can be detected. This is crucial when troubleshooting problems with dosage forms. SSCI's analytical capabilities include instruments capable of optical, thermal, or spectroscopic mapping. For example, using our IR microscope we can identify specific contaminants, determine the layered structure of a packaging material or map the homogeneity of a drug substance in a tablet.
Mapping is a valuable technique for complex products such as microspheres.
We can determine chemical identity of layers, thickness of layers with spatial resolution to one micron, and solid form. We also routinely develop full quantitative and limit test assays to monitor solid form in drug substances and drug products. Multiple techniques are used including XRPD, vibrational spectroscopy, NMR spectroscopy, differential scanning calorimetry, and moisture sorption. We are glad to develop a technique with your laboratory capabilities in mind as well as participate in transfer of a method from our labs to an in-line monitoring system installed on your production line. There can be many advantages to using the amorphous form of a drug.