Jing these would be shelf-life specifications. If the potency or moisture
levels changes significantly you would want tighter release specifications
Tony
On Fri, Mar 17, 2017 at 10:46 AM, Capucao, Jing [MCCUS] <
[log in to unmask]> wrote:
> 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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--
Tony Cundell, Ph. D.
Consulting Microbiologist
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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.
|
