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October 1998

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Subject:
From:
"Kuriakose, Lucy" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Wed, 7 Oct 1998 11:20:43 -0400
Content-Type:
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Here is a question for my Microbiology family members.
Do we need to do any Micro testing on a material that has low water content?
I have received a material called Lauroyl macrogolglycerid into our Micro
lab.  It is a waxy solid material. It is going into a solid oral dosage
form.

Additional information on this material : Prior to testing the material must
be heated to 66 degree C overnight. An oven bath or oil bath is acceptable,
a steam bath is not. The sample may be kept at this temperature for upto 72
hours, stability at this condition
has been established by the supplier.
Do I have to screen for thermophilic organisms? But what is their clinical
significance? From Dr. Cundell's article most of the organisms will not
survive in products with water activity below 0.60.
Please share your comments.


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