Drug Product Improvement, Method Development, Lot release
SSCI is able to analyze the solid form(s) of active drug in dosage formulations using various in-house analytical techniques. Most structural changes produced in the formulation process 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.