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Preservative Concentration
Hi all. I am working on a school project and I am hoping to get some advice on the amount of preservative to add into a gel formulation with a target shelf-life of 1 year. I intend to use a combination of methylparaben and propylparaben. Are there any guidelines/ studies done to show various amounts added and their corresponding shelf-life? Thanks for all your help!
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4 Replies
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lordofthefries said:…school project…gel with a target shelf-life of 1 year…Are there any guidelines/ studies done to show various amounts added and their corresponding shelf-life?…School project sounds like fun! Your proposed preservative has decades of intense use in cosmetics and pharmaceuticals. It is usually used at a fixed proportion. A water based gel will, if preserved adequately, manufactured properly, and filled in tubes but not jars or pipette bottles, be stable for up to a year. Given that your kids do not know what GMP is… I’d go with a 3 months expiration date at the most. Depending on composition, storage in the fridge might be advisable too.Are there guidelines: yesAre there studies: not applicable in your case -
Pharma said:lordofthefries said:…school project…gel with a target shelf-life of 1 year…Are there any guidelines/ studies done to show various amounts added and their corresponding shelf-life?…School project sounds like fun! Your proposed preservative has decades of intense use in cosmetics and pharmaceuticals. It is usually used at a fixed proportion. A water based gel will, if preserved adequately, manufactured properly, and filled in tubes but not jars or pipette bottles, be stable for up to a year. Given that your kids do not know what GMP is… I’d go with a 3 months expiration date at the most. Depending on composition, storage in the fridge might be advisable too.Are there guidelines: yesAre there studies: not applicable in your caseHi Pharma! Would you be able to tell me what the guidelines are? I am interested to read them and find out more.
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You might find this write-up from the EU helpful.
https://ec.europa.eu/health/sites/health/files/scientific_committees/docs/citizens_parabens_en.pdfBasically, use level of methylparaben & propylparaben would be 0.2 - 0.4%
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In pharmaceutical preparations, it’s often 0.05-0.1% at a ratio of 3:1 though the product is usually stored in the fridge if used at 0.05%.Apart from EU documents, I only have stuff written in German, sometimes not even available online.
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