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2. Is there information
demonstrating that the method
meets the SMPR Method
Performance Requirements using
the Reference Materials stated in
the SMPR? If not, then specify
what is missing and how this
impacts demonstration of
performance of the method.
Reference standards were acquired from a different vendor (Chromadex) than those
listed in the SMPR; however, purity of standards was evaluated by qNMR and is
therefore sufficient.
Matrix reference materials listed in SMPR were not used in this study (although they
are not yet available from NIST).
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:
0.3 mg/g (0.03%) for BDMC and DMC
1.6 mg/g (0.16%) for CUR
SMPR states 0.1%; met for BDMC and DMC, slightly high for CUR
Recovery reported: 96.6‐103.3%
SMPR states 95‐110%; met
Analytical ranges reported:
0.097‐0.943% for BDMC (1‐120 ug/mL cal range)
0.056‐8.096% for DMC (1‐100 ug/mL cal range)
0.377‐88.21% for CUR (5‐300 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 reported in supporting information are within range in SMPR (LT 5% at 0.1‐
50%; LT 3% at >50%) with one exception. BDMC at 0.373% in a tablet has RSDr of
5.5%.
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.
Yes (precision <5% for replicate samples throughout the run)
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 (table 2 of supplemental information)
4. Based on the supporting
information, is the method written
clearly and concisely? If no, please
specify the needed revisions.
Yes; will likely need to be reformatted from existing publication and supplemental
information into a single document for ease of reader
IV. General Submission Package