PMFLIST Archives

October 1998

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Subject:
From:
"Shih, Katherine" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Thu, 1 Oct 1998 16:38:41 -0700
Content-Type:
text/plain
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Michael:

Thank you.  (Your memory serves you right.)

Katherine Shih

> -----Original Message-----
> From: MICHAEL CARROLL (Sr. QA Mgr., Osteotech, Inc.
> [SMTP:[log in to unmask]]
> Sent: Thursday, October 01, 1998 11:38 AM
> To:   [log in to unmask]
> Subject:      Re: [PMFLIST] Endotoxin Limits
>
>      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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