A
________________________________________________________________________________________________________________________
WALTER ROUTH
Stability Section Manager
Lake County Operations
AbbVie, Inc.
Dept. 048D, Bldg. AP32/1
One N. Waukegan Rd.
North Chicago, IL 60064-6206
OFFICE +1 847-935-8676
CELL +1 847-513-1144
EMAIL [log in to unmask]
abbvie.com
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-----Original Message-----
From: Pharmaceutical Stability Discussion Group [mailto:[log in to unmask]] On Behalf Of Capucao, Jing [MCCUS]
Sent: Friday, March 17, 2017 9:46 AM
To: [log in to unmask]
Subject: [PSDGLIST] interpretation of specifications
Dear Folks,
This should be an easy one so please let me know your thoughts!
If you have acceptance criteria or specifications that are not indicated as either "for release only" or "for stability only", for example:
Active Assay: 90.0-110.0%
Unspecified Degradation Products: Not More Than 0.2%
Moisture: Maximum 5%
Do the specifications apply:
A: for both release and stability?
B: for stability only?
C: other, please specify...
Thank you in advance for your responses!
Jing
Jing Capucao, Ph. D.
R&D Stability Manager
Johnson & Johnson Consumer Inc.
[log in to unmask]
215-273-2441
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Avista Pharma Solutions - http://www.avistapharma.com/
Comprehensive testing and CMC services organization
Analytical and Microbiology support to early stage API and drug product development and manufacturing.
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
Cincinnati Sub-Zero - http://www.cszindustrial.com/
Provides a large selection of environmental chambers from benchtop, reach in to walk-in
rooms along with chambers for freeze/thaw, temperature cycling applications.
=================================
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.
------------------
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.
Avista Pharma Solutions - http://www.avistapharma.com/
Comprehensive testing and CMC services organization
Analytical and Microbiology support to early stage API and drug product development and manufacturing.
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
Cincinnati Sub-Zero - http://www.cszindustrial.com/
Provides a large selection of environmental chambers from benchtop, reach in to walk-in
rooms along with chambers for freeze/thaw, temperature cycling applications.
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