We perform the study on the BPO itself.
The only issue we ever see is rising assay.
We have never seen Benzoic acid increase by any appreciable amount. Our
Benzoic acid results are always relatively low for our product.
I agree, at 40C, I believe we may drive water off too quickly, ie run out
of spec high on the assay.
So-do we suggest ambient storage <38C or are we obligated to run at 38 and
see what happens or at 40 to match the guidelines or what?
Eileen M. Maher, QA/QC Manager
Arkema
3289 Genesee Street
Piffard, NY 14533
(585) 243-6300 phone
(585) 243-2649 fax
Gary Strickland <[log in to unmask]>
Sent by: Pharmaceutical Stability Discussion Group
<[log in to unmask]>
05/06/2011 08:55 AM
Please respond to
Pharmaceutical Stability Discussion Group <[log in to unmask]>
To
<[log in to unmask]>
cc
Subject
Re: [PSDGLIST] Safety vs. Stability
Hi Eileen,
Are you performing a stability study on the API (Benzoyl Peroxide - BPO)
itself or are you performing the study on a finished product containing
Benzoyl Peroxide?
If you are performing the study on a finished pharmaceutical, you should
not
have any problems regarding the drying out of benzoyl peroxide or the
safety
of the study. However, I would not expect benzoyl peroxide to be very
stable
(i.e. within the 90-110% specification) in an accelerated condition for
any
length of time. If you have an aqueous matrix, Benzoyl Peroxide will
convert
to Benzoic Acid relatively quick.
Gary Strickland
-----Original Message-----
From: Pharmaceutical Stability Discussion Group
[mailto:[log in to unmask]] On Behalf Of Eileen MAHER
Sent: Tuesday, April 26, 2011 4:19 PM
To: [log in to unmask]
Subject: [PSDGLIST] Safety vs. Stability
We have a product that has been made for >85 years and has been given a
recommended storage temperature because of safety concerns (<38C).
As this hydrophobic product ages, it drives off water and become more pure
(no change in impurities), but less water makes it more friction and shock
sensitive.
As an API, the stability protocol was set up using ICH guidelines
(30C/65RH) as dictated by largest customer of the API grade, but now we
have been asked how we can label with <38C when our data has been run at
30C. We would not want to run at >=38C for extended periods (like a 3 year
study).
Does anyone have a similar experience and if so, have there been any
issues with Regulatory agencies (US or Europe)?
Eileen M. Maher, QA/QC Manager
Arkema
3289 Genesee Street
Piffard, NY 14533
(585) 243-6300 phone
(585) 243-2649 fax
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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
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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
Environmental Specialties - http://www.eschambers.com/
Manufacturer of Quality Stability Chambers and
Provider of Complete Validation & Calibration Services
=================================
The nature of this service is to provide a medium for communication. The specific statements and endorsements of individuals participating in the discussions are not necessarily those of The Microbiology Network, Inc., the PSDG, or the sponsors of the list.
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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
Environmental Specialties - http://www.eschambers.com/
Manufacturer of Quality Stability Chambers and
Provider of Complete Validation & Calibration Services
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