Analytical Testing on Active Pharmaceutical Ingredients and Finished Dosage Forms
In full compliance with GMP requirements (EU-GMP), we store drug substances and finished products in climatized test chambers for short- and long-term stability studies.
The analyses are carried out in our specialized pharmaceutical control laboratory.
- Quality control tests for batch release according to specifications and pharmacopoeia
- In-vitro dissolution tests on formulations
- Physical tests on solid preparations (hardness, friability, disintegration)
- Analytical assistance for validation of cleaning procedures
- Method development and validation in accordance with GMP standards
- Stability testing (-20°C, 2-8°C, ICH conditions)
- Determination of elemental impurities