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December 2003

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Subject:
From:
Amy Jo Karren <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Tue, 2 Dec 2003 12:23:25 -0700
Content-Type:
text/plain
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text/plain (102 lines)
02 Dec 2003

Dear James,

The replacement of the pyrogen test with the LAL test  is covered in
the introduction and background sections of "Guideline on the Validation
of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test
for Human and Animal Parenteral Drugs, Biological Products, and Medical
Devices". USFDA, December 1987.

A copy of the guideline can be easily found on the FDA website.

Happy holidays,


Amy Jo Karren, B.S., RM (NRM), CQA
Microbiology Section Leader

Nelson Laboratories, Inc.
6280 South Redwood Road
Salt Lake City, UT  84123
Phone:  801-963-2600
Fax:  801-963-2630

E-Mail:  [log in to unmask]
URL:  nelsonlabs.com

>>> [log in to unmask] 12/01/03 09:49PM >>>
Fellows,

I have a question which is probably elementary to many of you but any
tuition that you may care to offer would be welcomed.  It appears that
the
classic rabbit-test for pyrogen has largely been supplanted by the LAL
test
for the presence of bacterial endotoxin on a monograph by monograph
basis.
Does anyone know of the guidance document that directs this
substitution?

Best regards,


JDonnell

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