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May 2011

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Subject:
From:
Brian Matthews <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Fri, 20 May 2011 19:17:35 +0100
Content-Type:
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How do the pharmacopoeia express the potentcy of gentamicin?
I note that the BP/Ph Eur have a potentcy statement:

Minimum 590 IU/mg (anhydrous substance).
In the case of Gentamicin Injection the BP has the following statements
under Assay and Labelling:

 Assay

Carry out the microbiological assay of antibiotics, Appendix XIV A. The
precision of the assay is such that the fiducial limits of error are not
less than 95% and not more than 105% of the estimated potency.

Calculate the content of gentamicin in the injection, taking each 1000  IU
found to be equivalent to 1  mg of gentamicin. The upper fiducial limit of
error is not less than 97.0% and the lower fiducial limit of error is not
more than 110.0% of the stated content.
Labelling

The strength is stated in terms of the equivalent amount of gentamicin in a
suitable dose-volume.

Regards,

Brian Matthews.



On 20 May 2011 02:14, Kate Ambrus <[log in to unmask]> wrote:

> Do you no longer titrate the lot you purchase again a standard
> gentamycin powder purchased from a lab that sells these standards. That's
> what we used to do to establish the activity of a purchased batch of
> antibiotic. I am assuming it is this "pure" substance referred to in the
> message below. I am sorry - we are going back into the 90's here, and I no
> longer recall who manufactured these standards in the US.
>
> The biological activity does vary from batch to batch and there is
> no straightforward correlation between the units and the micrograms. It
> depends on how many units are in each unit of weight of your purchased
> batch.
>
> Kate Ambrus
>
> --- On Wed, 5/18/11, LORRAINNE RIVERA <[log in to unmask]> wrote:
>
>
> From: LORRAINNE RIVERA <[log in to unmask]>
> Subject: Re: [PMFLIST] Converting I.U. to micrograms for Gentamicin Sulfate
> To: [log in to unmask]
> Date: Wednesday, May 18, 2011, 5:02 AM
>
>
> Hi Carolyn,
>
> I suggest you go through the USP <81>  Antibiotics -Microbiological assay
> "Units and Reference Standards" it states that for the pure substance 1mcg
> of biological activity is equivalent to mcg of weight.
>
> With the Gentamycin Sulphate, definitely it is not a pure substance but
> nobody knows how much exactly is the Gentamycin and how much is the
> sulphate
> in there. In that case you can use 1000IU/mg of Gentamycin as base.
>
> Hope this helps
>
> Lorrainne
>
>
> On Mon, May 16, 2011 at 9:40 PM, BERES Carolyn <
> [log in to unmask]
> > wrote:
>
> > Hello!
> >
> > I'm looking for some information regarding conversion of International
> > Units per milligram to micrograms per milligram for Gentamicin Sulfate.
> >
> > The Certificate of Analysis for drug powder I'm working with states the
> > potency in I.U./mg however the USP monograph (and nearly all
> documentation
> > I've found) states potency in micrograms/mg.  The only information I've
> > found that lists the potency for Gentamicin in I.U/mg is the WHO
> > Pharmacopoeia Library Monograph.
> >
> > USP monograph: minimum potency = >590 micrograms/mg
> > WHO monograph: minimum potency = >590 International Units/mg
> >
> > I'm interested in determining potency in micrograms/mg.  Since the
> minimum
> > requirements for potency appear to be the same (with the exception to
> > units), can I assume that I.U. is equivalent to micrograms?
> >
> >
> > Thank you in advance for your advice!
> >
> >
> > Cari
> >
> >
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> Please take a second to visit our sponsors' web sites and say thank you for
> their support of this service.
>
> Accugenix - http://www.accugenix.com
>
> American Type Culture Collection - http://www.atcc.org
>
> BD Diagnostic Systems - http://www.bd.com/ds/
>
> Biolog - http://www.biolog.com
>
> Biomerieux - http://industry.biomerieux-usa.com
>
> Biotest - http://www.BiotestUSA.com/micro<http://www.biotestusa.com/micro>
>
> MicroBioLogics, Inc. - http://www.microbiologics.com
>
> MODA Technology Partners: now a LONZA company http://lonza.com/moda
>
> Pall - http://www.pall.com
>
> NovaTek International - http://www.ntint.com
>
> Rapid Micro Biosystems - http://www.rapidmicrobio.com  (formerly GPS)
>
> Veltek Associates, Inc - http://www.sterile.com
>
> =================================
> The nature of this service is to provide a medium for communication.  The
> specific statements and endorsements of individuals participating in the
> discussions are not necessarily those of The Microbiology Network, Inc., the
> PMF, or the sponsors of the list.
>
> ------------------
> The PMFList (http://microbiol.org/PMFList_info.htm) is operated from
> The Microbiology Network (http://microbiol.org) and supported by
> our sponsors (http://microbiol.org/sponsor.htm) as a service to
> the scientific community.
>
> Please take a second to visit our sponsors' web sites and say thank you for
> their support of this service.
>
> Accugenix - http://www.accugenix.com
>
> American Type Culture Collection - http://www.atcc.org
>
> BD Diagnostic Systems - http://www.bd.com/ds/
>
> Biolog - http://www.biolog.com
>
> Biomerieux - http://industry.biomerieux-usa.com
>
> Biotest - http://www.BiotestUSA.com/micro<http://www.biotestusa.com/micro>
>
> MicroBioLogics, Inc. - http://www.microbiologics.com
>
> MODA Technology Partners: now a LONZA company http://lonza.com/moda
>
> Pall - http://www.pall.com
>
> NovaTek International - http://www.ntint.com
>
> Rapid Micro Biosystems - http://www.rapidmicrobio.com  (formerly GPS)
>
> Veltek Associates, Inc - http://www.sterile.com
>
> =================================
> The nature of this service is to provide a medium for communication.  The
> specific statements and endorsements of individuals participating in the
> discussions are not necessarily those of The Microbiology Network, Inc., the
> PMF, or the sponsors of the list.
>

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The PMFList (http://microbiol.org/PMFList_info.htm) is operated from
The Microbiology Network (http://microbiol.org) and supported by
our sponsors (http://microbiol.org/sponsor.htm) as a service to
the scientific community.

Please take a second to visit our sponsors' web sites and say thank you for their support of this service.

Accugenix - http://www.accugenix.com

American Type Culture Collection - http://www.atcc.org

BD Diagnostic Systems - http://www.bd.com/ds/

Biolog - http://www.biolog.com

Biomerieux - http://industry.biomerieux-usa.com

Biotest - http://www.BiotestUSA.com/micro

MicroBioLogics, Inc. - http://www.microbiologics.com

MODA Technology Partners: now a LONZA company http://lonza.com/moda

Pall - http://www.pall.com

NovaTek International - http://www.ntint.com

Rapid Micro Biosystems - http://www.rapidmicrobio.com  (formerly GPS)

Veltek Associates, Inc - http://www.sterile.com

=================================
The nature of this service is to provide a medium for communication.  The specific statements and endorsements of individuals participating in the discussions are not necessarily those of The Microbiology Network, Inc., the PMF, or the sponsors of the list.

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