Laboratory provides services in the field of stability and photostability testing according to ICH guidelines. It is equipped in modern climatic chambers which allow testing of API, reference materials, cosmetic products, food, packaging to establish the expiration dating period and storage conditions. Personalized analytical methods enables control of quality changes with time and under different environmental conditions (temperature, humidity and light)
- Stress stability testing
- Long-term testing
- Intermediate stability testing
- Accelerated stability testing
- Freezing-defrosting tests
We provide constant monitoring and recording of storage conditions and testing of samples according to specified procedures and timeframes. Analyses are carried out according to the actual ICH, FP, USP and Ph. Eur. guidelines. We have facility equipment and well-qualified staff in such areas as spectrophotometric techniques, gas chromatography, mass spectrometry, IR, microbial purity testing.
- Constant climate chambers Binder KBF 720
- Constant climate chambers with light and luminometers Binder KBF P 240
All devices have IQ /OQ /PQ qualification and are connected to software enabling detailed control of given parameters, in accordance with the requirements of the FDA (21 CFR Part 11), GLP/GMP.
Anna Kolbe-Panek, PhD – Laboratory Process Coordinator
Autor: PORT - Polski Ośrodek Rozwoju Technologii, Opublikowano: 30.11.2016