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FTIR ID reference not available for certain ingredients in OTC product
We’ve been working on a barrier cream that will be considered an OTC. The formulation includes ingredients that are not very common. Some of them are not on the FDA list of approved inactive ingredients, but all are currently used in other, similar OTC’s.Per 21 CFR 330, we are confident that all the inactive ingredients are safe and suitable for the product, but we want to be sure that we are compliant before getting this to market. Our current challenge is that our lab doesn’t have the reference standards to FTIR ID the following ingredients:
Olea Europaea (Olive) Leaf ExtractCitrus Aurantium Dulcis Peel Cera (Orange Wax)BentoniteOlivem 1000 (Cetearyl Olivate, Sorbitan Olivate)We really want to keep these in the formulation, so what would the bast way to proceed that ensures that we are FDA OTC compliant? Are the Orange Wax and the Olive leaf candidates for organoleptic ID?
Open to all feedback, and thanks so much in advance.
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3 Replies
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Olive leave extract isn’t one substance and it’s not even clear, what kind of extract it is… Even if you’re always using the same product but different batches, they’re never the same. IR may be suitable to a degree such as: band this or that has to be present (representing for example a major typical constituent) or has to be absent (typical peak of a spiked extract). Organoleptic should work though.In general, natural product mixtures are not too well suited for IR and citrus peel cera isn’t much different. Given that oranges don’t have a super strong variation in their composition, maybe you could make your own reference spectrum from a batch you identified by other means.Bentonite is another mixture (and a solid)… not sure if that one can be IR’d… -
Appreciate your answers!In the past we’ve been able to rely on FTIR IDs for other raw materials by tracking down a reference scan. If we are unable to do an FTIR here, I am wondering if there is another id that you can recommend?We want to do our due diligence to ID to meet FDA standards, wondering what lab tests might be a good addition to organoleptic (thinking that might be insufficient). -
Pharmacopoeia for bentonite
.Olivem should have melting point, saponification and other specs you could test.Olive extract: TLC or HPLC.The wax… meh…
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