Pharm Eur section 5.1.4 Microbial Quality of Pharmaceutical Preparations
address the issue of enteric bacteria. For example, Category 2 products,
Preparations for Topical use and use in the respiratory tract, are required
to have a spec of NMT 10 cfu/g of enterobacteria "and certain other gram
negative organisms" (it's too early in the morning to get into the "enteric
bacteria" vs. "enterobacteriaciae" vs "coliform" debate). Anyway, this
section of the Pharm Eur is binding as opposed to USP <1111> which,
technically speaking, is only "informational" (yeah, right). So, even
though the specs may not be in the monograph, the products are still
expected to meet the specs outlined in 5.1.4. I'm not sure if this
answers your question, but it's the best I can do being on this side of the
P.S. I wanted to let all the Forum member know that I actually saw 10
Bengal Tigers in NC last week!!! This just reinforces my proposal to
establish an "absence of Bengal tigers" specification for our park system.
Although these particular tigers were in a cage (several cages, actually)
there is a POSIBILITY that they could escape and run rampant in our fair
state's park system. You can never be too safe.
> -----Original Message-----
> From: Anthony Cundell [SMTP:[log in to unmask]]
> Sent: Thursday, October 28, 1999 3:52 PM
> To: [log in to unmask]
> Subject: [PMFLIST] Enterobacterial Counts and Clostridium Testing in
> Eur. Ph Monographs
> I looked in the Eur. Ph. to determine what raw materia and product
> monographs have Enterobacterial Counts and absence of Clostridium
> requirements and I cannot find any?
> I looked at some obvious ones like Acacia, gelatin, starch, etc and did
> not find a specific requirement.
> It would be helpful if our European colleagues could comment on how they
> apply these two proposed USP tests?
> Tony Cundell
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