Our CQAs and Instruments
CQAs
Quality Attributes
- Characterization
- Appearance
- Ceometry
- Identification
- Mechanical strength
- Water content
- IVRT
- Safety
- Impurity
- Insoluble particles
- Endotoxin
- Sterility
- Potency
- Assay / Assay uniformity
- In vivo / in vitro activity
Test Methods
- Characterization
- Microscope inspection
- Microscope measurement
- HPLC / IR
- Precision press testing machine
- Karl fischer
- Franz cell
- Safety
- HPLC
- Insoluble particles tester
- TAL
- Sterility test
- Potency
- HPLC
- ELISA/XTT / animal etc
Instruments
Microscope- Appearance
Pressure tester-Mechanical Strength
Karl Fischer -Water Content
Franz Cell-IVRT；IVPT
HPLC-Identification; Impurity
Insoluble Particle tester-Particles
Endotoxin detector-Endotoxin
Aseptic testing isolator-Sterility
Elisa Reader-API Activity
Rheometer - Viscosity
VISIA 7- Skin Irridation
PH/conductivity meter- PH
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