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Pharmaceutical Expertise - Headspace GC
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 With
the amount of testing required by the FDA on the actual drug substance,
and the packaging it is contained in, little testing, if any, is
being performed on the volume of gas between the product and the
container. This is where our expertise in “headspace” assays
is outstanding, and can be used to understand side reactions in
long term stability studies.
If we know what is in the finished pharmaceutical product, the
packaging material and the environment / gas that surrounds the
pharmaceutical product, which is inside the packaging, it provides
a more definitive understanding of what is occurring over time
to the product once put up on stability.
The current FDA guidelines are not specific on the need for
this testing, however, in our opinion we feel that it just a
matter of time before this scientific concern is addressed officially.
Those companies that are choosing to integrate this testing into
their general practice now will have an advantage.
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