An Initial Drug Substance Characterization (IDSC) report contains physical characterization and preformulation data for your Investigational New Drug (IND) filing. In the solid state chemistry group, we take a multidisciplinary approach for the study of solid forms. The analytical group will collect, analyze and summarize all data necessary for your regulatory documentation. Physical characterization data include form identification, solvent identification, hygroscopicity, micrometrics, and structure elucidation. Polymorph screening and form identification are also available. Preformulation data include equilibrium solubility, pH solubility, partition coefficient, pKa determination, and accelerated physical and chemical stability. We can collect all or part of the IDSC package, and the information will be summarized in a scientifically and QA reviewed report that will provide all the data necessary for regulatory submission.
The determination or confirmation of solid state molecular structure for a chemical entity can be performed with a combination of analytical techniques. Some of these techniques are mass spectrometry, NMR spectroscopy, infrared spectroscopy, elemental analysis, and single crystal X-ray diffraction. The solid state chemistry group is able to combine any or all of these techniques to address complex structural problems. Additionally, we are able to analyze solid dosage forms to determine any issues that may arise for example with drug product stability. High end instrumentation such as near infrared imaging and Raman mapping are often used in drug product analysis, however, a full list of instruments can be found here.