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Stability testing
Do most of you use an outside site for stability testing? I’m basically making mist (that I’ve done a thousand times before) and the client is asking me about stability testing. Honestly I freeze it, leave it under a humidifier, by the window or let it roll around in my car for 4 seasons. Not very advanced but I’ve been trusting it. Advice please.
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16 Replies
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If you sell, you should approach stability in a professional manner. You’ll find testing lab offering stability testing on the net.
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The buyers I work with would demand a more structured stability test. Unless you have the needed equipment on board, you are best to send it out. It also grants you third-party validation. -
Microformulation said:The buyers I work with would demand a more structured stability test. Unless you have the needed equipment on board, you are best to send it out. It also grants you third-party validation.
I understand. What is the document they present? Is stability a specialized field or could I produce one using proper conditions?
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They have the facilities and controls and will issue a report you can show your client.
Trying to establish it yourself will be tough and not cost effective.
See: https://ifscc.org/wp-content/uploads/2018/05/2-Fundamentals-of-Stability-Testing.pdf -
You would need lots of lab equipment that you likely don’t have. Our stability oven was over 10K when new and we have to get it certified yearly. We test objectively for SG, pH (calibrated and logged), Viscosity (Brookfield calibrated yearly), visual appearance, and other metrics. We observe it across 3 accelerated cycles for changes. The final certificate is signed by a Chemist.Don’t try to half-ass it or buy all that equipment for a rarely executed protocol. Call Microconsult for example out of Texas (https://microconsultinc.com/) and you would be surprised how affordable it is, especially when contrasted to buying the bench equipment. Also, you get a credible and credentialed certificate from a Professional. I consult with a company to evaluate these submissions to buyers, and we look closely at these forms.Don’t do it. Make a sample, FedEx it to a lab, and wait for the test results.
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If you’re worried about cost have you thought of billing the client for third party stability testing? Obviously be up front with them about the cost beforehand but many clients are willing to pay for professional stability testing if you aren’t able to provide it.
We have our own equipment in the lab but a few times clients have asked for a third party to also test the stability and we’d tell them the cost ahead of time and bill them for it.
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We have used Allied Analytical for stability testing in the past and they were great.
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Microformulation said:You would need lots of lab equipment that you likely don’t have. Our stability oven was over 10K when new and we have to get it certified yearly. We test objectively for SG, pH (calibrated and logged), Viscosity (Brookfield calibrated yearly), visual appearance, and other metrics. We observe it across 3 accelerated cycles for changes. The final certificate is signed by a Chemist.Don’t try to half-ass it or buy all that equipment for a rarely executed protocol. Call Microconsult for example out of Texas (https://microconsultinc.com/) and you would be surprised how affordable it is, especially when contrasted to buying the bench equipment. Also, you get a credible and credentialed certificate from a Professional. I consult with a company to evaluate these submissions to buyers, and we look closely at these forms.Don’t do it. Make a sample, FedEx it to a lab, and wait for the test results.
Gotcha. It doesn’t seem necessary though recommended. (For this simple formulation anyway)
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PhilGeis said:They have the facilities and controls and will issue a report you can show your client.
Trying to establish it yourself will be tough and not cost effective.
See: https://ifscc.org/wp-content/uploads/2018/05/2-Fundamentals-of-Stability-Testing.pdfThanks. I can for sure see my way is certainly not very credible in “report” format. I’ll double check that they really need this for a simple formula like this. I don’t see anyone asking for it though (retailers/health Canada/FDA)
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It is necessary - someone can claim a micro or chemical injury and you’ll have no data to refute and will hear their lawyer state you had not followed industry standards. FDA says -
“There are no U.S. laws or regulations that require cosmetics to have specific shelf lives or have expiration dates on their labels. However, manufacturers are responsible for making sure their products are safe. FDA considers determining a product’s shelf life to be part of the manufacturer’s responsibility.”
https://www.fda.gov/cosmetics/cosmetics-labeling/shelf-life-and-expiration-dating-cosmetics -
How much do stability tests cost in US?
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grapefruit22 said:How much do stability tests cost in US?
They vary, but I know Microconsult will email you an estimate if you submit the online form. They are affordable and used by many lines.
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Actually, I already have a lab I cooperated with, I’m just curious how my local prices compare with US prices in general. If I pay 140 USD for a stability test (16 weeks, 4 & 40 °C, product packaging vs glass benchmark), would you say it’s a good price?
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@grapefruit22 Yes, that is a great price, especially with a credible lab and the stability report. You may find that your clients will like the fact that the test was sent off for “third-party stability validation.”
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@Microformulation, thanks, good to hear that.
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@grapefruit22 Hi, do you mind if I ask who are you using for your Stability Testing as that is an awesome price
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