The key element here is that the product is to be used in a solid oral dosage
form.  What is the possibility that an oral pathogen has gotten into the
product, i.e. natural origin product.  Many organisms will survive in a low
water environment.  They will no grow but will survive.  A classic example is
the survival of Salmonella in Thyroid Tablets for up to a year.  The
Salmonella came in through the thyroid glands, survived the drying process and
was incorporated into the tablet.

If the wax is a synthetically manufactured product the chance of an oral
pathogen is probably low.  The heat that is supplied during sample preparation
will kill most oral pathogens.  I think a rationale can be developed to
exclude this product from testing.

Terry E. Munson
KMI/Parexel


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