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2. Does the method contain
system suitability tests or
controls as specified by the
SMPR? If not, please indicate
if there is a need for such
tests or controls and which
ones.
no; Can't find a blank injection of the extraction solvent.
3. Is there information
demonstrating that the
method system suitability
tests and controls as
specified in the SMPR worked
appropriately and as
expected? If no, please
specify.
YEYS
4. Based on the supporting
information, is the method
written clearly and concisely?
If no, please specify the
needed revisions.
YES
5. Based on the supporting
information, what are the
pros/strengths of the
method?
fully automated derivatization, as an online post-column derivatization System is used.
The method is also applicable to complex dietary supplements like soft-gel capsules
containing other plant extracts and a variety of excipients
6. Based on the supporting
information, what are the
cons/weaknesses of the
method?
con: from a practical point-of-view: I would assume that only a few labs will have and
use this derivatization system
7. Any general comments
about the method?
I think an alternative procedure for off-line derivatization (e.g. with AQC-reagent) should
be described.
Do you recommend this
method be adopted as a First
Action and published in the
Official Methods of Analysis
of AOAC INTERNATIONAL?
Please specify rationale.
By voting strictly according to the given SMPR I have to recommend this method, as all
requirements are fulfilled with excellent Validation data. From a practical point of view
my concerns are that only a few labs may have this online derivatization System from
Pickering. I would recommend to include an alternative for this labs. This could be an
off-line derivatization e.g. with AQC-reagent, which is quick and fast and stable.