Stability test - Chemists Corner

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Stability test

Posted by Rencelj on April 6, 2016 at 6:19 am

Hey forumites, long time i wasnt here. I would like to ask you question regarding stability test.

Can it be done in my “lab” with my readings and than i can check every week, same day for another 8 weeks? Or do i need to give it to other companies and than they send me papers saying passed or not?

Because i was thinking to lunch new products but wondering if i really need other labs to do it or can i writte paper ? This is in EU.

PET test i already send and they were ok, but for stability i was thinking to make it by myself. I have also samples more than 1 year old and are just fine, like first day.

Regards

Greg

Mike_M replied 8 years, 8 months ago 3 Members · 9 Replies
9 Replies

Chemist77

Member
April 6, 2016 at 6:33 am

Don’t see an issue with that, provided you have good ovens and other supporting tools.
Rencelj

Member
April 6, 2016 at 7:21 am

But i see some companies have not done on temperature but on centrifuge. Do you think i can buy cenftrifuge equipment and do it that way ?

Regards
Chemist77

Member
April 6, 2016 at 7:51 am

That’s one thing you can do as well but again it’s better to have a complete approach.
Rencelj

Member
April 6, 2016 at 8:22 am

So 3,5h at 3000 rpm is equal to 1 year stability?
Chemist77

Member
April 6, 2016 at 9:53 am

Sorry but I never came across such time of calculations and equations, I am more into the traditional things like an elevated temperature study in oven.
Rencelj

Member
April 6, 2016 at 10:22 am

Calculations:

Relative Amount (%) = [Volume Instability Phenomena] x 100

[Volume Total]

Ex). Total Volume = 10 mL

Volume of Settled Material = 1.0 mL

Relative Amount = (1.0 / 10) x 100 = 10% Settling
Rencelj

Member
April 6, 2016 at 10:25 am

atleast this is what i found on net. But like i said, my question is if i can make also with centrifugation stability tests ?

Regards

Greg
Rencelj

Member
April 6, 2016 at 11:16 am

If i buy chamber for stability test, can i give than stability test to myself/products after 8 or + weeks of controling?

Because for CPSR , we need PET testing and stability testing. PET testing i will give to outsourcing lab, but stability testing i was thinking to do it in my lab/cosmetic production with chamber that has :

0-60’celsius with -+0.1 accuracy, fluctation 1%+-

humidity 50-90 %

timing range 0-999min

So on end i dont need other labs or outsourcing to make stability test of produucts that will be relesed on market?

Regards
Mike_M

Member
April 6, 2016 at 2:38 pm

Run in it in the chambers. I’ve done both and there’s correlation but it’s not a guarantee. Run on at room temperature and at elevated. You can easily run it yourself. I would take pH and viscosity readings at the minimum.