Purification of unknown impurities by preparative HPLC
Manufacturing of emulsions and suspensions by High Pressure Homogenization
Stability testing and storage of medicinal products in climatic chambers:
Standard
- Climatic zone II, 25°C/60% RH
- Intermediate conditions, 30°C/65% RH
- Accelerated testing, 40°C/75% RH
on request
- Climactic zone IVa, 30°C/70% RH
- Climactic zone IVb, 30°C/75% RH
Refrigerated storage
- 2°C to 8°C
Freezer storage
- -20°C
considering ICH conditions and on-going conditions (in accordance with GMP requirements)
Blister packaging (in accordance with GMP requirements)/
Screening of packaging material (foils)
semi-automatic blistering (Blister-Omar)
