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July 2020

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Subject:
From:
Donald English <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Wed, 8 Jul 2020 11:41:13 -0400
Content-Type:
text/plain
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Dear Henry,

An oil-in-water emulsion is not really oily.  Oil product formulation mostly consist of mineral oil such as a bath oil.  The usage of oil-in-water emulsions are very rare for drug product formulations.  They are mostly found Instead to be cosmetic product formulations.  I have found that most drug microbiologists have not and will never see an oil-in-water or a water-in-oil product emulsion in all probability because they are working with simple aqueous product formulations from an ingredient perspective with the exception of some creams and ointments.

The USP is very good in how to test aqueous product formulations, but the guidance in how to test what I call  atypical product formulations Is somewhat lacking and not sufficient from my perspective.  To perform testing on these atypical product formulations, it comes mostly from experience in performing microbial content and challenge testing on these types of product formulations and not by just reading a USP chapter.  Part of this experience comes from knowing how to formulate product formulations in which most microbiologists have a lack of understanding and why certain ingredients besides preservatives are present in a product formulation.

Don

Donald J. English Microbiological Quality Consulting LLC
Florham Park, New Jersey 07932.

Sent from my iPhone

> On Jul 8, 2020, at 10:17 AM, Henry Yepwi <[log in to unmask]> wrote:
> 

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