Chemical Forums
Specialty Chemistry Forums => Chemical Engineering Forum => Topic started by: gumusonur on December 25, 2018, 05:16:48 AM
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hi?
When a raw material with an expiration date of 6 months is used in product construction, why can the expiry date of the last product be given for 3 years?
how can we explain?
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If you produce a new product then the time for expire dates start with the manufaction date and end 3 year later. During production your raw material will be changed or transformed, so it doesnt matter is it new or 6 month old., but it should be not older then 6 month.
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it may not always be changed, it may be a constituent in a formulation such as a filler powder in a tablet, so it's a good question. But mostly if it's a pharmaceutical product we are only worried about the API itself, and how rapidly it degrades. But the expiration date of a product such as this has to be validated with data. 3 years is actually a long time so the product would be pretty stable.
Also, a raw material API would be less stable on its own, normally in a formulation, you would add other ingredients to extend its shelf life.
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usually we add preservative to product. i think this situation be help protect to our product. but even so i am not sure exactly.
cosmetic product not include API. we should work stability test. but we cant test every raw material in a product. how can explain i do not know.