Drug Product Improvement, Method Development, Lot release

Drug Product Development

SSCI is able to utilize its powerful analytical method development capabilities to determine the solid form(s) of active drug in formulations. Additionally, these methods are used to determine the stability of the drug product and formulation. Most structural changes produced in the formulation process or occurring during storage can be detected and eliminated and the process improved. This is crucial when troubleshooting problems with dosage forms. We routinely develop full quantitative and limit test assays under cGMP to monitor solid form in drug substances and drug products. SSCI also issues certificates of analysis for lot release on both drug product and drug substance. SSCI is a leader in developing and analyzing amorphous formulations for enhanced solubility.