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October 1998

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Subject:
Re: Endotoxin Limits
From:
"MICHAEL CARROLL (Sr. QA Mgr., Osteotech, Inc." <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Thu, 1 Oct 1998 13:37:58 -0500
Content-Type:
text/plain
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text/plain (40 lines) 
     Katherine:
        The only exceptions to the 5.0 EU/Kg rule that I'm aware of, are
     intrathecals, which (if memory serves) are 0.2 EU/Kg..... I believe
     the "per Kg" part is supposed to account for pediatrics: Smaller body
     mass--
        M.Carroll ([log in to unmask])


______________________________ Reply Separator _________________________________
Subject: [PMFLIST] Endotoxin Limits
Author:  <[log in to unmask]> at INTERNET-MAIL
Date:    9/29/98 11:31 AM


Hi:

We use 5 EU/Kg as the endotoxin limit for parenteral products.  Is there
a lower limit for pediatric products?   Are children/infant more
sensitive?  Thank you in advance for your help.

Katherine Shih
Oread
>


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