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 Extractables
are defined as “compounds that can be extracted from
elastomeric, plastic compounds or coatings of the container
and closure systems when in the presence of appropriate solvents
under vigorous conditions.”
The
Regulatory guidelines indicate that an extractables profile
should be determined for all materials that contact the drug
or patient directly and during the early stages of development
candidate materials should be “screened” as to
their suitability on this basis.
Two stage approach
Rapra
has developed a two-stage approach to extractables profiling
of polymeric components
A
Qualitative Compositional Analysis (QCA)
A
QCA will enable clients to specify the most appropriate suite
of analytical tests and conditions in a subsequent control
extraction study and more importantly to ensure that any potential
extractables/migrants are not overlooked,
Information
relating to the composition of polymers or rubbers, especially
specific data relating to the additive package and low molecular
weight species such as monomers, solvents and initiators must
also be considered. (These types of compounds are typically
those with the highest potential to migrate from the polymer
into the drug matrix).
This
information may already be available from the manufacturer
(material specification datasheets) and may include some or
all of the following depending on the polymer type:
Monomers
Initiators
Antioxidants
Antistatic Agents
Heat Stabilisers
Lubricants/Process Aids/Plasticisers
UV Absorbers
Fillers
Flame Retardants
Modifiers (e.g. Impact)
Coupling Agents
In
cases where this information is not available from the manufacturer
or is not considered to be reliable, then the data must be
gained from analytical studies.
In
addition, the information gained from the manufacturer of
the bulk polymer would not cover any potential extractables
that may have contaminated the surface, been absorbed into
the polymer matrix, or been generated during the processing,
handling and storage of the polymer in its lifetime. Again
analytical studies will be required to identify such additional
species.
Although
there is no one analytical technique that could cover the
identification of all of these potential migrants, Rapra has
developed a robust protocol to rationalise the testing required.
Interested
in the details covered here, then why not contact us?
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