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In use study for a bottle of capsules
#1 · August 28, 2025, 7:30 am
Is there any region where there is a regulatory requirement to do in use stability studies on a bottle of capsules or tablets . I would argue they arent multidose and are covered by the normal stability studies
#2 · September 29, 2025, 12:45 pm
There is no requirement for in-use stability study on a bottle of tablet or capsule. It is specially required for reconstituted or liquid products.
You can read the below guideline: https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-use-stability-testing-human-medicinal-products_en.pdf
