Analytical Facility
The Quality Control Department has the latest testing instruments to ascertain the chemical quality and powder properties of drug substances.
We have also established laboratories for microbiological testing and testing of highly pharmacological activity substances, ensuring a robust quality evaluation system.
In addition to quality testing, we also support reduction of new drug development period from quality control aspect, such as analytical method transfer from contract givers, method validation, and research and development of analytical methods.
In 2024, we introduced a laboratory information management system (LIMS), focusing on strengthening our data integrity (DI).
Main Facilitys
HPLC/GC Testing Labaratory
Testing laboratory equipped mainly with separation analysis instruments
This laboratory is equipped with approximately 50 HPLC units and about 30 GC units, as well as multiple units of IC, UPLC, LC-MS/MS, and GC-MS. These are properly managed by the two types of analytical network systems.
Physicochemical Testing Laboratory
Testing laboratory equipped with major analytical instruments other than separation analysis
Instruments are managed by the network systems or as standalone instruments.
Similar to management by the network systems, standalone instruments are also properly managed by using functions, such as electronic data management, back-up, and audit trail.
This laboratory also includes a low-humidity testing room for handling hygroscopic samples.
Microbiological Testing Laboratory
Testing laboratory dedicated to microbiological testing, meeting the requirements of the Biosafety Level 2 (BSL-2) of the Laboratory Biosafety Guidelines (WHO 3rd Edition). Security-controlled interior is maintained to meet the clean room standard Class 100,000, equipped with a toxinometer, incubators, clean benches, and safety cabinets.
High Pharmacological Testing Laboratory
Testing laboratory with containment functions, suitable for handling highly active drug substances. Balance enclosures (BE) are installed in the room to ensure that the containment performance is OEL 1μg/㎥ or less (measured according to the SMEPAC standards).
Facilities / Equipment
| Equipment type | Specifications |
|---|---|
| High performance liquid chromatography (HPLC) | UV、RI |
| Ultra-performance liquid chromatography (UPLC) | UV、PDA |
| Ion chromatograph (IC) | ECD、CＤ |
| Gas chromatograph (GC) | headspace、FID、TCD |
| LC-MS/MS | UV、PDA |
| GC-MS | |
| ICP-MS | |
| TOF-MS | |
| LC/Q-TOF-MS | |
| UV-Visible Spectrophotometer（UV） | |
| Infrared Spectrophotometer（FT-IR） | |
| Atomic absorption spectrophotometer | |
| Polarimeter | |
| Nuclear magnetic resonance spectrometer (FT-NMR) | |
| Particle size analyzer: | dry and wet |
| X-ray diffractometer | |
| Karl Fischer moisture meter | Coulometric Method, Volumetric Method, Evaporation Method |
| Potentiometric titrator | |
| Total organic carbon system (TOC) | |
| Electrical conductivity meter | |
| Constant Humidity | temperature chamber: 25℃/60%RH, 40℃/75%RH, 5℃(refrigerator), -20℃ |
| Electronic balances | micro, semi-micro |
Inquiries
Please feel free to contact us even for small-scale production or small projects
Inquiries by Phone
[Available Hours] 8:30 – 17:00 on
weekdays (excluding Sat. Sun. and national holidays)
