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Sampled have a fully-qualified Photostability chamber dedicated to photostability testing
The chamber holds 25°C for the duration of the study, and is equipped with radiometers/lux meters. These meters control the bank of lights, turning them off when the appropriate amount of lux hours and watt hours/meter have been achieved according to the ICH guideline. The chamber is also equipped with a Hark cloud based data recorder.
These photostability tests demonstrate the effects that light might have on your products. The samples are then subjected to various photodegradation studies, including assays and visual tests. From the resulting stability profile, you will be able to select appropriate packaging to protect your product, and identify what degradants might occur when the product is exposed to light.
As per ICH option II, their photostability testing laboratory exposes your samples to:
- A cool white fluorescent lamp specified in ISO 10977(1993)
- A near UV fluorescent lamp with spectral distribution from 320 nm to 400 nm
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