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Tagged: stability testing
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Vitamin C Toner failed stability test
Posted by juliap3 on December 8, 2015 at 11:59 amHII recently put forward my toner for stability test, which failed. The colour changed from pale yellow to deep golden at week 8 during the 45C test but nothing else changed, the ph 6.5, so I am assuming that the failure was the Vit C (Sodium Asorbyl Phosphate) oxidising.This was my formula, can anyone suggest what I could add to stabilise the oxididation.Water to 100%Peg 40 Hydrolysed Castor Oil 2%Hydroxy-propyltrimomium honey 3%Sodium Asorbyl Phospate 1.5%Phenoxyethanol & Ethlhexylglycerin 1%Aqua, Glycerin, Cucumber extract 0.7%Aqua, Glycerin Pommegranate Fruit Extract 0.7%Allantoin 0.5%Citric acid 0.02%Aloe Vera Powder extract 0.15Rose Geranium 0.1%Vitamin E 0.1%Sweet Orange 0.1%Frankincense 0.06Many thankssandydijon replied 9 years ago 8 Members · 15 Replies -
15 Replies
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I am beginning my own development of a vitamin C serum at the moment using Apprecier (Trisodium ascorbyl palmitate phosphate) and research I have already done shows me that there is no way you can expect it to be stable at 45C. In fact even at room temp it will degrade in weeks rather than months. The graphs in the published data show that these formulations do degrade and that temperature is a major factor as is free oxygen in the mixture.
It is recommended to include dihydric alcohols in the formula. For some reason I can’t locate it at the moment but I have a document from Showa Denko recommending two types, e.g. propane 1,3 diol, may have been one, unfortunately I can’t obtain them here.I intend making ours in small batches, keeping them in refrigeration and recommending the customer does likewise and use within 3 weeks. -
I recently had stability testing success with a Vitamin C serum, using sodium Asorbyl Phosphate at 5%, I added anti-oxidants, Gamma Oryzanol and Vitamin E, I think this helped with the oxidation and the serum is packaged in an airless / container which also helped. With this success I had hoped the Vit C Toner would have the same success, but this is packaged in a standard bottle with an atomizer so oxygen could possibly get to the product. I am from the UK so all products have to go through regulatory stability testing and if there are any changes in the 1st 8 weeks of the testing schedule of 12 weeks the formula is deemed unstable, and therefore fails. I am looking for water based or glycerin based anticoxidant which might improve the stability of the Vit C toner. .
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“I am from the UK so all products have to go through regulatory stability testing”
- I have seen no regulations to that effect, can you give a link please? -
Are you restricted to “natural” products?
Also, I have a hard time with the idea that a cosmetic product that’s not heat stable at 45C can’t ever be sold in the UK. 45C (113F) is much hotter than any consumer product is likely to see in it’s lifetime. I understand that it’s a standard temperature for accelerated stability testing, but I would be shocked if there’s not an exception in there somewhere. -
Er, why do you need an “ethical safety assessor” in the first place?
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“… you’ll need a safety assessment done by a qualified safety assessor in the EU.”
Not that I sell in the EU currently, but I have read the UK regulations for personal care products and I didn’t see anything about that. And the UK is in the EU. Could you provide a link please?
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I had a client recently who was based in the EU, so I took some time reviewing the regs. In the EU, for cosmetics, you do indeed have to submit a safety report prepared by a safety assessor. And, your products must be registered. It is quite a bit more stringent that here in NA.
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Look at pdf’s page 21:
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:342:0059:0209:en:PDF
Also you must confirm PAO (period after opening) with stability test. -
Thank you for the PDF. What concerns me is that in the UK for instance, in the past, bureaucratic regulations have been used to keep small companies out of the market. For instance, in the 1990s, the cost of passing mandatory government tests kept many innovative companies from competing with inferior products in the telecomms marketplace. I have to wonder what these “safety assessors” are charging for their service.
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That’s true, unfortunately. You may need over 1000 euro for a complete safety assessment on one product. So many small companies sell their products illegally, or don’t have complete regulation.
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@heraklit 1000 euro!!!!! that’s a serious ripoff - our regular assessor charges £230 per product, and if they’re assessing several very similar products, the additional charge is about £30-50 per variant
@Belassi, by ‘ethical’ I mean someone who does the job thoroughly, actually considers the effects of the product on the consumer, and the potential for it to cause any harm during reasonable use
the vast majority of safety assessors I’ve dealt with fall into this category, but there are a few cowboys out there who will sign off any old rubbish
recent example of the latter: a customer came to us wanting to produce a hair colour remover they’d had developed elsewhere
the active ingredient was a bleaching agent meant for use on for fabric and paper(!), with little to no toxicology data, which released a considerable amount of formaldehyde in situ, enough for it to smell very strongly
and yet, despite all that, an assessor in the UK had signed it off and approved it!
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1000 euro for the complete safety report including dermatological, challenge, stability tests, toxicological profile, plus the cost of the assessor (about 200+ euro each one).
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Can you redo another batch and remove all the citrus essential oil and citric acid? Increase the Vitamin E to 0.5 and see.
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