ICH Stability Studies

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ICH Stability Studies

Stability Chamber(IQ/OQ/PQ, annual calibration): temperature, humidity, light

Stress testing，accelerate, long-term, intermediate, etc.
Stability sample management
Stability testing: chemical properties, physical properties

Stability Management

Development of stability indicating HPLC method
Drug substances and products
Clinical supplies
Protocol driven
Customer defined report format
Chamber IQ/OQ and calibrations