Why only 1.2 million lux hours require in photostability study?
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Answer Posted / Nikhil Verma
The requirement of 1.2 million lux hours in a photostability study is based on international guidelines (such as ICH Q1B) to ensure the adequate exposure of the drug product to various light conditions, simulating potential degradation pathways and predicting the long-term stability under different light sources.
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