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February 2016

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From:
Juan Ortega <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Sun, 31 Jan 2016 16:59:18 -0600
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Hello,
What about when the FDA request microbial assay data for certain 
antibiotic product that assay via HPLC is validated/ acceptable, and the 
microbial assay is not in USP monograph?  The product is not even listed 
in USP Chapter <81> in regards to specific test parameters, media, buffer, 
microorganisms, incubation, median dose of the standard, etc. 
Unfortunately without a solid Scientific justification we can not argue 
the FDA - They make the rules, and we must follow them.  All validation 
samples including raw material and release testing samples  must be tested 
via microbial assay. 

Good luck!
 
Juan Ortega 
Microbiology Supervisor 

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From:   Frank Settineri <[log in to unmask]>
To:     [log in to unmask], 
Date:   01/30/2016 12:14 PM
Subject:        Re: [PMFLIST] Antibiotics-Microbial Assay USP <81>
Sent by:        The Pharmaceutical Microbiology Forum Email List 
<[log in to unmask]>



Shashi,
You need to follow the USP monograph.  Some antibiotics allow for chemical 
testing, others do not.  For example, Tobramycin is assayed by 
chromatography and Gentamicin is assayed by USP <81>.
Thanks Sincerely,

Frank Settineri 
Veracorp LLC 
Sparta, New Jersey 
908-499-5540 
www.veracorp.biz 
http://www.linkedin.com/in/veracorpStrengthening Businesses, Strengthening 
Lives
 

    On Friday, January 29, 2016 2:54 PM, Shashi Raju <[log in to unmask]> 
wrote:
 

 Hi All,

Is it acceptable to use HPLC method of analysis for Antibiotics to analyze 
validation samples and use Antibiotics-Microbial Assay USP <81> for 
Release and stability. 

USP states as below in the chapter <81>,

"A reduction in antimicrobial activity may not be adequately demonstrated 
by chemical methods"

Thanks 
Shashi Raju

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The PMFList (http://microbiologynetwork.com/pmflist.asp) is operated from
The Microbiology Network (http://microbiologynetwork.com) and supported by
our sponsors 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.

Accuratus Lab Services http://www.accuratuslabs.com/

Associates of Cape Cod, Inc. - http://www.acciusa.com/

Nelson Labs - http://www.nelsonlabs.com

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

Biolog - http://www.biolog.com

Analytical Research Labs - http://arlok.com/

Life Technologies - http://www.lifetechnologies.com/PharmaAnalytics

Charles River-Endosafe and Accugenix - http://www.criver.com/emd

Accugen Laboratories - http://accugenlabs.com

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

ATS Labs - http://www.ats-labs.com

EMD Millipore -  http://www.emdmillipore.com/biomonitoring

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

Microtest Laboratories, Inc. - http://www.microtestlabs.com

Steris - http://www.sterislifesciences.com/

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

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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://microbiologynetwork.com/pmflist.asp) is operated from
The Microbiology Network (http://microbiologynetwork.com) and supported by
our sponsors 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.

Accuratus Lab Services http://www.accuratuslabs.com/

Associates of Cape Cod, Inc. - http://www.acciusa.com/

Nelson Labs - http://www.nelsonlabs.com

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

Biolog - http://www.biolog.com

Analytical Research Labs - http://arlok.com/

Life Technologies - http://www.lifetechnologies.com/PharmaAnalytics

Charles River-Endosafe and Accugenix - http://www.criver.com/emd

Accugen Laboratories - http://accugenlabs.com

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

ATS Labs - http://www.ats-labs.com

EMD Millipore -  http://www.emdmillipore.com/biomonitoring

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

Microtest Laboratories, Inc. - http://www.microtestlabs.com

Steris - http://www.sterislifesciences.com/

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

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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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