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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 testing and sample storage to
support our customer’s needs in relation to drug substance and
drug product stability.
Our stability testing and storage meet ICH guidelines. Various
ICH storage conditions are available, and are monitored using a
validated Kaye Lab Watch ™ System.
25°C/60% RH
30°C/60%RH
40°C/75%RH
Other conditions offered are: 5°C, -20°C and –80°C.
All stability chambers are fully validated to meet strict temperature, humidity and uniformity requirements. All chambers are monitored 24 hours a day and are connected to emergency generator power to ensure integrity of stored samples.
The following techniques are used to support stability programs:
- Dissolution Testing
- GC
- Particle Size
- HPLC
- Gel Electrophoresis
- Surface Area and porosity analysis (nitrogen adsorption)
- X-ray Powder Diffraction
- DSC
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