In your arcticle you reccomend temperatures of 4-50 C.

Wy do you not consider the

stbility after freezing or even with repeated thaw-freeze circles We know that in real life
during storage and transport the products often have to face such conditions.
We often see that especially raw material suppliers do not consider this part of stability
testing when presenting frame formulations based on their raw materials and calling them
stable.
besr regards
Heike Schelges

Direct Reply

Perry Romanowski says:

January 6, 2015 at 11:11 pm

Hello Heike,

Thanks for your comments. Freeze / Thaw testing is another excellent method for
predicting the stability of your formula. It is typically used in addition to the stability
test method outlined above. It can give you a quicker sense of whether a product will
separate or not and works best for emulsion products.

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o Adri says:

January 12, 2015 at 3:25 pm

The freeze thaw is best for stab of emulasions, so start with it do not wait
for two months and fail then.
Every stab test should be considered intelligently
Many emulasions do never survive 45 so: industry standard is often 3 mth at
40/42.
In EU the actual, marketed formula should be tested. The prototype is not
good enough (unless identical).

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David O'Halloran says:

January 6, 2015 at 10:22 am

Dear Perry,

An opportunity to explain so much more. I do a guest lecture every other year at the FDU
Masters Fragrance class and I focuss mostly on Stability.

I have a large Stability group here at Givaudan catering to the Fine Fragrance and Specialty
Retail companies.
Would love to discuss with you an opportunity to get a Cosmetic Stability Course given as I
do believe this is such an important Topic.

Best Regards,
David OHalloran
Director of Fragrance Cosmetic chemistry
Givaudan Fragrances
NY, NY 10019
212-649-8878

Direct Reply

Perry Romanowski says:

January 6, 2015 at 11:13 pm

Hello David,

Thanks for your comments. Sure Id love to hear more. You can contact me at
perry.romanowski @ gmail.com

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Petra Wirth says:

January 7, 2015 at 4:09 am

Very good idea we are involved in safety assessments for cosmetic products and
advice our clients concerning stability testing. it is very important to see also the type
of cosmetic product to define the parameters which should be tested during stability
testing for example for natural cosmetics the pH is a very important parameter
because most of the preservatives used for natural cosmetics work only at low pH
values. Best regards, Petra Wirth, alphachem, Services for the cosmetic industry /
Regulatory affairs

Direct Reply

o Perry Romanowski says:

January 7, 2015 at 11:59 am

Yes. Sometimes performance tests should also be included as part of your

stability testing protocol

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Javier Guandalini says:

January 6, 2015 at 7:31 pm
Thank you! Perry. Great advice.
regards, Javier

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Drew Edell says:
January 7, 2015 at 9:49 am

I agree with the above comments stability is perhaps the number one priority in product
development / formulation. I and with 30 years experience believe this area of product
development is not well understood particularly for the newer members of the formulating
community. In particular the various time intervals and conditions required to establish a
sound stability testing protocol.

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Perry Romanowski says:

January 7, 2015 at 12:01 pm

There could certainly be more work done into creating a more precise stability
protocol. Often people ask me about how to speed things up. Unfortunately, there
arent a lot of things you can do beyond accelerated temperatures.

Direct Reply

o Adri says:

January 12, 2015 at 3:32 pm

Freeze thaw and centrifuging are good examples of not long term/storage at
diff temps. In all cases intelligent interpretation is key. A failing challengetest
is usually known within a week. A good CT result takes ~4 weeks.

Would like to be involved in such a course (we did something like that in my
former company) and prepare it for the EU (safety assessments).

Direct Reply

Perry Romanowski says:

January 7, 2015 at 11:59 am

This may make a good topic for a continuing education course with the SCC

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Court land Imel says:
January 7, 2015 at 11:22 pm

Perry,
Great thoughts as always. I know you touched on packaging concerns, but I do want to raise
the need to evaluate your formula in an inert package as well as the intended final package.
We continue to see a number of our clients that fail to evaluate final package and a recall
follows. I agree with Drew that this information must be passed down. I agree that a stability
program training should be part of the CE program. I will offer my help in any FDA side of
the presentation.

Thank you for raising this important issue.

Courtland

Courtland Imel
CEO
Ceutical Laboratories, Inc.
972-241-8374

Direct Reply

Perry Romanowski says:

January 12, 2015 at 2:27 pm

Thats excellent Courtland. We could almost do a whole seminar on this topic.

Direct Reply

Matthew Thorpe says:

January 8, 2015 at 10:07 am

Great Article!

My job involves the investigation of fragrance performance in various product bases, so one
of the most important aspects is to determine fragrance stability over time. As you
recommend, I determine stability over a range of temperatures, but also look at the effect of
UV light on product samples. My current UV testing apparatus was constructed in-house and
utilises a bulb that effectively mimics daylight, i.e. light is emitted in the visible range as well
as the UV range of the spectrum. I am currently experiencing difficulties sourcing more
professional, custom-made equipment for this purpose. Are you able to offer any advice that
might aid me in my search?

Many thanks,
Matthew.

Direct Reply

Perry Romanowski says:

January 21, 2015 at 11:35 am

sorry, I cant recall which light box brand we used.

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 Ronald J. Versic says:
January 8, 2015 at 10:20 am

The sentence Stability testing isnt exact science, but its good enough for the purposes of
cosmetic products. tells it all. There is no exact science here for the following reason:

Aging is due to accelerated reactions that have different free energies.

The term good enough skips over the exact science and minimizes it by ignoring it.

So were left with wishful thinking. Theres nothing more to aging then that. Wishful
thinking!

Direct Reply

Perry Romanowski says:

January 12, 2015 at 2:29 pm

Youre right, there is some wishful thinking involved in stability testing. Many times a
test will come out fine but a different batch will fail stability. Its unfortunate but until
we get supercomputers that can model the happenings of molecules inside a formula,
this is the best weve got.

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sandra says:
January 12, 2015 at 6:22 am

It is a really interesting article. I would be interested in exploring the topic. Is there any
publication that you can recommend us ? Or otherwise , have you planned some seminar that
we can attend?

Thank You

Direct Reply

Perry Romanowski says:

January 12, 2015 at 2:33 pm

Both the PCPC and the IFSCC publish monographs on the topic of stability testing.
IFSCC monograph no. 2 (Fundamentals of Stability Testing) covers this subject.
You can search their websites for more information.

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o sandra says:

January 13, 2015 at 5:53 am

 Thanks for the information!

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David Steinberg says:

January 12, 2015 at 6:49 am

Dear Perry,

Wouldnt it be nice if the EU had a stability method for 30 months stability. This way you
could see if yu needed Period After Opening or Best used by symbols.

Direct Reply

Perry Romanowski says:

January 12, 2015 at 2:31 pm

Great point David, lol. Unfortunately, legislators pass laws which are not usually
written by scientists.

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Adri says:

January 12, 2015 at 3:38 pm

Would be nice: one method is impossible due to the great differences between
samples and markets. Also intended usage is a very important factor.
I hope no one will try to design an ISO standard for this

There is a Colipa report and some info from the SCCS. Good stuff to use in
interpretation of results!

Direct Reply

Sherrill Archer says:

January 16, 2015 at 3:45 pm

Hi Perry
I am new to the cosmetics industry. Are there cosmetic industry specific testing protocols to
meet different jurisdictional requirements or is it up to the manufacturer to design and
execute a stability study?

Direct Reply

Perry Romanowski says:

January 21, 2015 at 11:36 am

 In the US it is up to the manufacturer to come up with an appropriate stability testing
protocol.

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Mercedes Cocera says:

May 26, 2015 at 3:30 am

Good morning,
What we can consider about mixtures of ingredients that are formulated to be incorporated to
a final product, in stability terms?
Is it necessary to perform the stability tests in the same way for a final product or for an
ingredient?
Thank you very much

Direct Reply

Perry Romanowski says:

July 30, 2015 at 8:50 am

Its better to do stability tests on the final formula. Ingredients can interact and you
have no way of knowing that if youve only tested the ingredients by themselves.

Direct Reply

APRIL says:
June 9, 2015 at 7:51 pm

I was on your webinar today and thought it was excellent. Will you be sending out a
recording of your presentation or could you possibly send me a copy of the slides?

Direct Reply
Wanling says:
July 30, 2015 at 5:38 am

It is an interesting ariticle! But sir, do you have any journal to support that 45C for 8 weeks is
equivalent to 1 year? I am planning to do stability testing on my product. I proposed to my
manager but he require me to find journal or thesis to support this theory. However, I cannot
find any journal to support it. Do you mind to share with me?=) Thanks a lot.

Direct Reply

Jovena says:

March 22, 2017 at 12:16 am

Hi. have you found any journal or article t support below statement?
An industry rule-of-thumb is that a sample stored at 45C for 8 weeks is equivalent
 to one that is stored at room temperature for one year.
Thank you in advance =)

Direct Reply

TAYCIR BAHLOUL says:

January 23, 2016 at 3:37 pm

Hello,
thank you for your article.
For Against I have some questions about the stability of a cosmetic product:
1- Accounting test content / container: I want to know the test period and analyzes that can be
done to confirm the stability of the product.
2- For the stability test under extreme storage conditions (under a UV lamp and exposed to
the sun), I also want to know the test period to assess the stability of the formula.

Direct Reply
Anna Davidenko says:
July 13, 2016 at 2:23 am

Hello,

Perry.

Could you say please what test can guarantee the shelf life of the product 1, 2 and 3 years?
Thank you in advance,

Anna.

Direct Reply

Perry says:

July 19, 2016 at 8:38 am

There are no tests that guarantee stability for 1, 2, or 3 years.

The best you can hope for is that there is a good chance it will be stable.

The industry standard is 45C for 8 weeks will predict 1 year at RT stability. And 1
year at RT will predict 3 years at RT.

But there really arent any good stability tests predictive of more than a year.

Direct Reply

o Anna Davidenko says:

August 25, 2016 at 11:11 pm

 Perry,

thank you!

Is it true that 1 year at RT will predict 3 years at RT ??? How is it possible?

Physical and chemical parameters can change after 18-24-36 months so how is
it possible that 1 year is guarantee of 3 years.

Thank you in advance!

Direct Reply

o Jovena says:

March 22, 2017 at 12:18 am

Hi. May I know where can find the reference for this statement?

The industry standard is 45C for 8 weeks will predict 1 year at RT stability.
And 1 year at RT will predict 3 years at RT

Thank you.

Direct Reply

Perry Romanowski says:

March 22, 2017 at 9:32 am

I do not know of a published reference for the statement. It is an

industry rule-of-thumb not settled science.

Direct Reply