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3. Is there information
demonstrating that the method
performs within the SMPR Method
Preformance Requiements table
specifications for all analytes in the
SMPR applicability statement? If
not, please specify what is missing
and whether or not the method's
applicaiblity should be modified.
LOQs reported:
0.92 ug/mL (0.09%) for BDMC
1.33 ug/mL (0.13%) for DMC
2.86 ug/mL (0.29%) for CUR
SMPR states 0.1%; met for BDMC, slightly high for DMC, high for CUR. *Calculations
to % done without inclusion of methanol density, which would actually make them
higher and further from requirement
No recovery information provided.
Analytical ranges reported:
0.09‐1.66% for BDMC (0.6‐15 ug/mL cal range)
0.39‐10.3% for DMC (1.7‐42 ug/mL cal range)
0.00016‐25.2% for CUR (4‐100 ug/mL cal range)
SMPR requests 0.1% to >50%; based on levels in products and the calibration ranges
demonstrated, I have no concern about this method working in this range.
RSDrs for one BDMC test, one CUR test, and 3 DMC tests are outside of the range in
SMPR (LT 5% at 0.1‐50%; LT 3% at >50%). Values range from 6‐7%. 6 samples were
tested.
1. Based on the supporting
information, were there any
additional steps in the evaluation
of the method that indicated the
need for any addional
precautionary statements in the
method?
No
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
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.
N/A
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/strenghts of the method?
The method is straightforward and relatively simple. It has been tested on a number
of matrices (as suggested in Table 3 of SMPR) and in the presence of numerous
other botanicals (including 2 from Table 2 of SMPR).
IV. General Submission Package