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March 2013

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Subject:
From:
Mike Yang <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Fri, 8 Mar 2013 09:26:47 -0800
Content-Type:
text/plain
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Betzaida,

For controlled room temperature, the USP has very specific requirements in
USP 32, Section 10.30.60.

The mean kinetic temperature is the isothermal representation of a
non-isothermal environment. A temperature excursion always needs to be
interpreted carefully. The stability study at accelerated condition should
be consulted for the possible ill effect of a short spike of temperature
excursion.

Attention should be paid not only for the chemical property, but also
physical property. For example, semisolid dosage forms may not sustain
higher temperatures physically.

Here is an interesting analogue - What is the mean kinetic temperature if
eggs are stored at 20°C for 20 hours, 4 hours at 2°C,100 hours at 25°C, and
0.5 hours at 95°C? The answer is 35.9°C. However, the eggs are possibly
spoiled.


Best Regards,

Mike Yang, Ph.D.
ScienTek Software, Inc. | P.O. Box 323 | Tustin, CA 92781-0323 |
www.stabilitysystem.com <http://www.stabilitysystem.com/>
TEL: (714) 832-7435 | [log in to unmask]



On Tue, Feb 26, 2013 at 11:05 AM, Betzaida Rosario <
[log in to unmask]> wrote:

> Dear Stabilitarians,
>
> Can you please  help us with the followings:
>
> If we have a MKT result of 29°C  for an environmental excursion for about
> 2 weeks :
>
>
> What is the meaning of that value?
> Samples stored at the affected chamber (25/60) are impacted?
> It is a warning of inadequate control system?
> We need to calculate the MKT with a minimum of 52 weeks?
> What step do I have to follow if an MKT=29°C
>
>
> Thanks in advance for your support
>
> Best regards,
>
> Betzaida Rosario
> Suehail López
> Stability Coordinator
> Blu Caribe
> Dorado, PR
>
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The PSDGList (http://microbiol.org/psdglist.htm) is operated from The Microbiology Network (http://www.microbiol.org) and supported by our sponsors as a service to the scientific community.   Please take a second to visit our sponsors' web sites and say thank you for their support of this service.

BahnsonEnvironmental Specialties - http://www.eschambers.com/
   Manufacturer of Quality Stability Chambers, Warm & Cold Rooms, Freezers and
   Ultra Low Storage Chambers with Complete Validation, Maintenance & Calibration

Stability Environments, Inc., an affiliate of Solar Light Company, Inc. - http://www.StabilityEnvironments.com
   High quality controlled environmental walk-in rooms and reach-in chambers
   Full installation, validation and spare parts also available

Hardy Diagnostics - http://www.HardyDiagnostics.com
    Provides a complete selection of laboratory and microbiology supplies
    for the clinical, industrial, and molecular biology research communities.

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