The
United States Pharmacopoeia (USP) is considering major changes
to medical gas testing requirements
The latest
USP journal Pharmacopeial Forum contains significant proposed
changes for testing medical gases. This issue (July/August
2002 Vol. 28, No. 4) is due to be published within the next
two weeks. Here are some of the proposed changes:
Oxygen
Assay – the new test method is proposed to be the
paramagnetic
oxygen analyzer. This would replace the wet chemical method.
Identity – the new test method for identity would
be included as
a part of the assay test.
Nitrogen
Assay – the new test method is also proposed to be
the paramagnetic
oxygen analyzer. This would replace the gas chromatograph
method...
much faster!
Carbon Dioxide
Assay – the new test method is proposed to be gas
chromatography.
This would replace the Orsat wet chemical method.
Nitrous
Oxide and Helium
Assay – the new gas chromatograph column is 1.8 meters
long.
This will result in much faster analyses.
Air
Oxygen content – the new test method is also proposed
to be the
paramagnetic oxygen analyzer. This would replace the electrochemical
method.
Gas
Chromatographic Methods
GC parameters (temperature, flow, etc.) and system suitability
parameters (precision, resolution, etc.) would be explicitly
specified. This would clarify much ambiguity in the present
monographs.
Remember
that these proposed changes have a long way to go before they
become official. First they are published in Pharmacopeial
Forum. Then comments, with scientific justification, are received
and republished, if necessary. Finally, some version of the
new monographs would be published as a revision to USP. This
process could take months... or years.
AsteRisk
will continue to monitor Pharmacopeial Forum, and other sources,
to bring you the latest information about medical gas compliance.
We will post the latest information at www.AsteRisk-Inc.com.
Thank
you,
Tom
Badstubner
(800)
432-5038
TLBadstubner@AsteRisk-Inc.com
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