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October 1999

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Subject:
From:
M Carroll <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Wed, 13 Oct 1999 17:40:39 -0400
Content-Type:
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This refers to the FDA-mandated  "guideline" on validation of LAL testing
methods; it means evaluating your product and system to insure that there
are no substances present which will either inhibit or enhance the LAL
reaction and give false positive or negative results. Presumably, if you
expect certain degradation products to be present in steadily-increasing
concentrations with product aging, you would need to ensure that these do
not build up to levels where they would interfere with testing which was
perfectly valid on un-aged product.
M.Carroll ([log in to unmask])

On Wed, 13 Oct 1999 11:27:22 -0400 "Harder, Joel"
<[log in to unmask]> writes:
> What is an "inhibition/enhancement profile"? How does it relate to
> LAL
> testing? Thanks in advance.
>
> Joel C. Harder
> * v-mail: 703-351-5942
> * e-mail: [log in to unmask]
>
>
> -----Original Message-----
> From:   Tony Coyle [mailto:[log in to unmask]]
> Sent:   Wednesday, October 06, 1999 10:09 AM
> To:     [log in to unmask]; [log in to unmask]
> Subject:        Re: [PMFLIST] Endotoxin testing of dry products on
> stability
>
> Dear Mark
>
> The draft guidance document is ambiguous and leaves
> the decsion to the stability study administrators. The
> reason for this is that ascientific judgement has to
> be made as to whether the degradation products are
> likely to have an effect on the analytical method.
>
> For LAL testing I advise that the
> inhibition/enhancement profile be determined for
> stabilty study lots if available to account for this
> possibility.
> Remember that the registered LAL procedure should be
> valid throughout the life of the product so it would
> be prudent to include this requirement in the
> stability study protocol.
>
> I hope that this helps but should you require any
> further information please don't hesitate to get in
> touch.
>
>
> --- Mark E Claerbout <[log in to unmask]>
> wrote:
> > Dear forum members,
> >
> > I am interested in getting opinions as to the need
> > to perform LAL testing on
> > dry sterile dosage forms on stability, and whether
> > of not companies are
> > routinely doing this.  The 1998 FDA draft guidance
> > document on Stability
> > Testing of Drug Substances and Drug Products
> > indicates it "may" not be
> > necessary (page 38 of the document), which seems
> > rather ambiguous to me.
> >
> > thanks in advance for any responses,
> >
> > Mark Claerbout
> >
> >
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