PMFLIST Archives

October 1999

PMFLIST@LISTS.MICROBIOLOGYNETWORK.COM

Options: Use Monospaced Font
Show Text Part by Default
Condense Mail Headers

Message: [<< First] [< Prev] [Next >] [Last >>]
Topic: [<< First] [< Prev] [Next >] [Last >>]
Author: [<< First] [< Prev] [Next >] [Last >>]

Print Reply
Mime-Version:
1.0
Content-Type:
text/plain; charset=US-ASCII
Date:
Mon, 11 Oct 1999 11:54:50 -0400
Reply-To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Subject:
From:
Anthony Cundell <[log in to unmask]>
Content-Transfer-Encoding:
quoted-printable
Sender:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Comments:
Parts/Attachments:
text/plain (33 lines)
During product development the robustness of the preservative is demonstrated at 100, 75 and 50% of label claim.

Batches on stability are subject to AET with in the shelf specification not at the highest concentration.

Tony Cundell
wyeth-ayerst

>>> <[log in to unmask]> 10/10 10:42 PM >>>
When conducting the B&F test, are folks typically using product with the
highest labeled concentration of the preservative or simply testing the
product at whatever preservative level it may have, e.g., midpoint of the
labeled range?  Has FDA told anyone that they must conduct the B&F test at
the highest labeled preservative concentration?

Richard Prince
[log in to unmask] 


------------------
The PMFList (http://microbiol.org/PMFList_info.htm) is operated from
The Microbiology Network (http://microbiol.org) and supported by
our sponsors (http://microbiol.org/sponsor.htm) as a service to
the scientific community.


------------------
The PMFList (http://microbiol.org/PMFList_info.htm) is operated from
The Microbiology Network (http://microbiol.org) and supported by
our sponsors (http://microbiol.org/sponsor.htm) as a service to
the scientific community.



ATOM RSS1 RSS2