Quality Control
The Quality Control Department has an up-to-date testing instrument for ascertaining the chemical quality and powder properties of the drug substance. We have also established facilities for microbiological testing and highly pharmacological activity substance to ensure a thorough quality evaluation system. In addition to quality testing, we will also support a reduction in the development period for new drugs from the standpoint of quality control, including transfer of analytical techniques to the contract research organization, validation of analytical methods, and research and development of analytical methods.
Main facilities in QC center
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HPLC/GC testing laboratory
Testing laboratories with mainly separate analytical instruments. See the list below for more information on analytical instruments.
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Physical and Chemical testing Laboratory
Testing laboratories that provide major analytical instruments other than separation analysis. See the list below for more information on analytical instruments.
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Microbiology testing laboratory
Testing laboratories dedicated to microbiology testing that meets the BSL2 of the Laboratory Biosafety Guidelines (WHO3rd Edition). Security-controlled indoors are controlled to meet Class 100,000 of the Clean Room Standard and include toxicometers, incubators, clean benches, and safety cabinets.
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High Pharmacology testing laboratories
Testing laboratories suitable for handling highly active drug substances with containment functions. Balance closures (BEs) are installed in the room to ensure that the containment capacity is less than 1 μg/Ⅶof OEL (measured according to SMEPAC standards).
Analytical equipment
| Description of equipment | numbers | Note |
|---|---|---|
| HPLC | 45 | UV/RI |
| UPLC | 4 | UV/PDA |
| LC-MS/MS | 1 | UV/PDA |
| GC-MS | 1 | |
| IC（Ion chromatograph） | 2 | ECD/CD |
| GC | 27 | Headspace/FID/TCD |
| ICP-MS | 1 | |
| TOF-MS | 1 | |
| Micro electronic balance | 1 | |
| electronic balance | 14 | |
| UV spectroscope | 1 | |
| FT-IR spectroscope | 1 | |
| Atomic Absorption spectroscope | 1 | |
| Polarimeter | 1 | |
| 400MHz FT-NMR spectroscope | 1 | |
| Partucle size distribution measurement device | 2 | wet/dry |
| XRD（X-ray diffractometer） | 1 | |
| （Karl Fischer）water content measurement device | 5 | Coulometric/volumetric/vaporization equipment |
| Potentiometric Compact Titrators | 2 | |
| TOC（Total Organic Carbon）measurement device | 1 | |
| Electrical conductivity | 1 | |
| Constant temperature and drying oven | 5 |
25℃/60％RH ×2 40℃/75％RH 5℃（Refrigerator） -20℃（Freezer） |
