A comprehensive quality assessment will be conducted throughout the entire R&D cycle to ensure quality and safety. Quality assessment includes physical and chemical properties, stability, resolution rate and so on.
In FC Center, testing methods come from the official pharmacopieas such as ChP, JP, JPE, USP/NF, EP, and other special functional testing covering stability, medication compliance (bitter masking, mouth feeling etc.)
| Evaluation Items | |
| ■Preparation condition review ■Testing methods and interim specification review ■Testing analysis Characteristic Dosage confirmation Purity Quantitative ■Preparation assessment I PSD Hardness Fragility Disintegration （ordinary tablets, ODT） Formulation uniformity Loss on drying |
■Preparation assessment II
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