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DMDM Hydantoin
I want to know what compound can be combined (and at what %) with DMDM Hydantoin to achieve broad-spectrum protection against bacteria, mould and fungus?
I will be using it in purely a water-based serum with a pH of 5.5.
Ingredients are roughly as follows:
Water
Niacinamide
PG
Glycerine
HA
PanthenolThanks.
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11 Replies
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I would maybe use Iodopropynyl Butylcarbamate (Fungicidal).
Recommended use 0.1-0.3%. pH 2-10.
You can get it from the same supplier - Lonza. Trade name Glyacil L
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you may not need another DMDMH is broad spectrum.Only problem is formaldehyde releaser
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DRBOB@VERDIENT.BIZ said:you may not need another DMDMH is broad spectrum.Only problem is formaldehyde releaser
You will need another and IPBC is a good reco. One should design a preservative system that should be broadly effective and then confirm with a PET. Do not use PET to minimize a system - quantitatively or qualitatively.
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We have used DMDMH alone in a myriad of systems ie creams lotions gels etc with products having micro-integrity for 3+ years via OTC/USP preservation testing. Unnecessary Overloading of a preservation system can lead to skin problems such as contact dermatitis and so on.Preservative as rule of thumb should be < 1.0% wt/wt.
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DRBOB@VERDIENT.BIZ said:
We have used DMDMH alone in a myriad of systems ie creams lotions gels etc with products having micro-integrity for 3+ years via OTC/USP preservation testing. Unnecessary Overloading of a preservation system can lead to skin problems such as contact dermatitis and so on.Preservative as rule of thumb should be < 1.0% wt/wt.Preservation should be designed to be broadly effective (esp. if qualified using <51>) and within parameters of safety in use - not by “rule of thumb”.
The primary purpose of presrvation is to protect consumers in use - how much in-use testing have you done?
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We have sampled from the field to verify.How much do you do and how many samples ?
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DRBOB@VERDIENT.BIZ said:We have used DMDMH alone in a myriad of systems ie creams lotions gels etc with products having micro-integrity for 3+ years via OTC/USP preservation testing. Unnecessary Overloading of a preservation system can lead to skin problems such as contact dermatitis and so on.Preservative as rule of thumb should be < 1.0% wt/wt.
At what percentage have you used DMDMH?
And generally, for what sort of products?
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I worked for a large, global company - to qualify systems and test, we conducted tests on products recovered after consuner use from each of the major geographies. I’ve worked with other companies who targeted 1000 recovered samples - not for every product but for systems and to qualify their preservative test.
I understand your general concern - but encourage that folks err on the side of microbiological safety within the safety-in-use parameters of preservatives. Think your success speaks very well of your GMP’s and manuf hygiene, esp. if your using <51>.. -
At what percentage have you used DMDMH?
And generally, for what sort of products?-CREAMS/LOTIONS @0.5% WT/WT%-NO longer use it due to formaldehyde release as most customers want Form-free.Also used Gydant Plus at lower level 0.3% .Creams lotions gels etc-
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I worked for a large, global company - to qualify systems and test, we conducted tests on products recovered after consuner use from each of the major geographies. I’ve worked with other companies who targeted 1000 recovered samples - not for every product but for systems and to qualify their preservative test.I did the same for major Pharm Co doing new product Development on WW basis.You can probably guess the company-now making Covid single dose vaccine.
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Guess was incorrect. ‘”Company” not currently in the pharma biz.
Per level - If you’re marketing in EU, you’ll want to keep the free formaldehyde less than 500 ppm or suffer labeling as contains formaldehyde*. Experience - this drives to 2000-2500 ppm range for most formalehyde releasers, including DMDM Hydantoin.
*Annex IV - “All finished products containing formaldehyde or substances in this Annex and which release
formaldehyde must be labelled with the warning “contains formaldehyde” where the
concentration of formaldehyde in the finished product exceeds 0.05%.”
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