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About time in Incubator, or how to test expired of product?
hi all, I’m new customer of incubator, my instrument code is Memmert IN55
I heard about testing expired product similiar this:
put sample into incubator, set 45 Celsius and set time cutdown: 3moths equivalent to 1 year in outside environment
Is it correctly? cause i check in manuals, doesnt mention about that
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12 Replies
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anyone have ẽxperience with it? mr @PhilGeis
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40-45C for 1 and 3 months. I’d NOT go beyond 3 months or 45C. I’ve gone to market with passing preservative data from 1 month.
The ex date projected from this kind of testing is kinda flakey. There is an ISO method 18811 that prob could be seen as precedent but its no more validated than any. The comment you use is about as good as any.
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@oldman20 That is the parameter for subjecting pharmaceutical products to stability analysis of the active API. Too often mistaken for same parameters for thermodynamic formulations such as ours. I suggest 42C maximum or 40C. Many personal care formulations will liquify at 45C, which negates the validity! Check samples every 30 days for physical integrity, appearance, pH, viscosity changes. Yes, 3 months accelerated stability roughly equates to 12 months at RT if not longer. Interpret results with objectivity: I have seen samples fail at 42C/60 days but were still intact six years later in their trade package.
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as matt said
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many thank for information. do u have any link, edition relates to that? i cant find anything exclude Word of mouth
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and just curious: how they decided push that product into markets when it doesnt pass time in incubator?
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I’ve used passing data with product aged 1 month at 40C as justification to market - confirmed with data from 3 month 40 and real time.
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As matt said, conventional is - 40-45C one and three months, with latter approx 1 year stability. I’ve gone to market on 1 month data for cosmetics and 3 for OTC’s. .
This is rule of thumb - not validated - and may be be appr. for all products. You must execute real time stability to confirm.
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As matt said - 40-45C for 1 and 3 months. For accelerated, I’d not go greater in temp or longer in time. Rule of thumb is 3 months accelerated/rapid aged product data justifies 1 yrs stability but that is not validated. I use 1 month stability (preservation) data to justify marketing for cosmetics and 3 for OTC drugs with 1 yr ex data. .
You must confirm with real time data out to three years.
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“A twenty-four month expiry period may be assigned upon successful completion of three months accelerated testing.”
chpa.org
The objective of this guideline is to define the minimum stability data package to support the commercial distribution of OTC monograph drug products in the United States per climatic zone.
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I would also check the compliance requirements of the cosmetics regulatory authority for the country where you are located to check that the information you have provided conforms with what you have been provided here.
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thank all of you for responding. Good day for all, cheer
and Merry Christmas!
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