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Stability Testing- Hair Conditioner Spray
I was wondering if a product contains only water soluble ingredients, in check stability do I need to do temperature variations or can I only do packaging stability test.
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8 Replies
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One of the benefits of doing temperature variations is that you can get an accelerated shelf life determination. So you can get a 2 year shelf life in 6 months testing instead of waiting the full 2 years to label it. This is beneficial to you as the seller but also from the buyers at the stores you want to sell. They want products with certain expiration periods.
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Stability testing at different temperatures will also give you an indication if your product will be ok during the temperatures encountered during shipping.
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3 months stability testing at 40C gives you a year shelf life. 6 months at 40C gives you 2 years. So I suppose it depends on how long you need to guarantee shelf life for. I know our buyers want 18 months minimum but generally 2 1/2-3 years preferred.
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We used to live by the rule that 8 weeks at 45C was predictive to a year of RT stability.
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@Mike_M can I only do the test at 40C and freeze and thaw. Or do I also need to do room temperature and other different temperatures.
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The answer is that it really just depends. Check out ICH guidelines, but basically we do 40C for 6 months, room temperature for 2 years and freeze thaw for 6 weeks. If we run into issues with the 40C and we’re pressed to get a product out without waiting on the room temperature then we’ll run 30C and run that out. Like Perry mentioned you could do 45C instead of 40, it all depends. Some systems might crash at 45 that would be perfectly okay at 40 and the same goes for 30. Different accelerated tests will give you different time tables for shelf life. When I was doing innovation we did 50C, 4C and RT.
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@Mike_M thank you I really appreciate the help.
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