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Reliable testing and sample storage
you can trust
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In today’s market, understanding the effects of temperature and
humidity on chemical purity as well as potency, bioactivity, particle
size, surface area and crystalline phase transitions, is crucial
to developing a better product.
At Micron Technologies, we offer stability testing and sample
storage to support our customers’ needs in relation to drug substance
and drug product stability.
Our stability testing and storage capabilities meet International
Conference on Harmonisation (ICH) guidelines. Various ICH storage
conditions are available, and are monitored continuously to ensure
compliance to ICH requirements. Storage conditions currently offered
by Micron Technologies include: 25°C/60% RH, 30°C/65% RH, 40°C/75%
RH, 5°C and -20°C.
All stability chambers are fully validated to
meet strict temperature, humidity and uniformity requirements. They
are connected to emergency generator power to ensure integrity of
stored samples.
The following techniques are commonly used to
support stability testing programs at Micron Technologies:
- High Performance Liquid Chromatography (HPLC)
- Dissolution Testing
- Particle Size Analysis by laser diffraction
- Surface Area analysis by nitrogen adsorption
- X-ray Powder Diffraction
- Differential Scanning Calorimetry (DSC)
- Moisture Testing
- Dynamic Vapor Sorption
Our Quality Assurance Group reviews all analytical
data to ensure product quality and adherence to cGMP guidelines.
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