Home > Research Strength > WesternMedicine > Drug analysis > Drug evaluation and registration service

Drug evaluation and registration service

《Dissolution testing》


【Dissolution test of the registration of medicinal products】
The Center has passed the TAF validation and can be delegated for executing the drug dissolution profile comparison in accordance with the TFDA regulations.

【Development of drug and bio-dissolution testing】
It is for the evaluation before the BE study. Experiments use a dissolution medium simulating the status of fasting and satisfaction to develop and execute dissolution testing for predicting in vitro drug releasing.

▲300 practiced cases accumulated

《Development of chromatography》


1.Develop the appropriate of qualitative or quantitative methods according to the physical-chemical properties of the analyzed substance.
2.The Center is available for HPLC, UPLC, GC, and LS-MS for various analytical developnat (development?).
3.Provide customized experiment design and reports from developing analytical methods to confirming effectiveness.

《Particle property testing》


Apply the techniques of laser diffraction and dynamic light scattering for testing particle size distribution from the various range of 0.0003-10 µm and 0.01-3500 µm for providing the row materials and products of herbal and drug medications.

The Zeta potential is changed with the surface property, solution pH, electrolyte types and solution electrolyte concentration of the nanoparticles. The instrument of the Center uses Laser Doppler Micro-electrophoresis to measure the particle Zeta potential and which can be use as the stability index of the electrophoresis.

《Fluid property testing》


The level of retention or lubrication of semi-solid drugs are often controlled by the viscosity or viscoelasticity.

1.Viscosity measurement: Test levels of viscosity. Matters have various viscosity.
2.Viscoelasticity measurement: Viscoelasticity is a combination of both the viscous and elastic characteristics. This is also the flow combination of viscous fluid and elastic solid.