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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.
Yes.
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.
Yes.
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?
This method utilizes readily available instrumentation and reagents and gives accurate
and reasonably precise results. The HPLC conditions were optimized to give relatively
rapid results and the sample preparation steps were simple and straight forward. The
method therefore, should be useful for quality testing purposes.
6. Based on the supporting
information, what are the
cons/weaknesses of the
method?
The chromatography showed peak tailing and lack of baseline resolution for some of
the analyte peaks. Some of the %RSD precision results were high for minor catechins.
Use of all of the individual catechin standards
7. Any general comments
about the method?
This method could be optimized by individual laboratories with minor modifications of
chromatographic conditions. Determining relative response factors for the minor
catechins might be advisable for routine quality testing work.
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.
Yes. The method is appropriate and applicable to routine testing for quality purposes.
Additional work may need to be performed to determine the application in supplement
forms not addressed in the journal reference: e.g., liquids, soft-gelatin capsules.