Forced degradation study to be performed to achieve purposeful degradation that is predictive of long term and accelerated stability conditions.

For confirmatory studies, samples should be exposed to light providing an overall illumination of not less than 1.2 million lux hours and an integrated near ultraviolet energy of not less than 200 watt hours/square meter to allow direct comparisons to be made between the drug substance and drug product.



Make: Thermo Corporation