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June 2013

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Subject:
From:
"Lund, Boyd M" <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Mon, 10 Jun 2013 20:11:06 +0000
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What's the rationale for this?  The only non-parenteral dosage form that I'm aware of that requires endotoxin is (recently) ophthalmics, which are sterile. 

Regards,
 
Boyd

-----Original Message-----
From: Pharmaceutical Stability Discussion Group [mailto:[log in to unmask]] On Behalf Of RC Pantola
Sent: Friday, June 07, 2013 8:03 AM
To: [log in to unmask]
Subject: [PSDGLIST] endotoxin test in non-sterile products

Dear Friends,
I would like to know about the endotoxin testing in non sterile products , number of our customers are asking for the endotoxin test in non sterile products even some of the products are water insoluble, and some of customers  are rigid for to have the endotoxin test in such products.Please share your experience ,standard scientific approach for below query.

1-Is it possible to have successful testing of endototin testing in non-sterile products (water soluble and water insoluble)?

 Thanks for your comments in advance.

    R.C.Pantola

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BahnsonEnvironmental Specialties - http://www.eschambers.com/
   Manufacturer of Quality Stability Chambers, Warm & Cold Rooms, Freezers and
   Ultra Low Storage Chambers with Complete Validation, Maintenance & Calibration

Stability Environments, Inc., an affiliate of Solar Light Company, Inc. - http://www.StabilityEnvironments.com
   High quality controlled environmental walk-in rooms and reach-in chambers
   Full installation, validation and spare parts also available

Hardy Diagnostics - http://www.HardyDiagnostics.com
    Provides a complete selection of laboratory and microbiology supplies
    for the clinical, industrial, and molecular biology research communities.

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