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one supplier)
Reference standard availability for delta-di-6S
Cost of running assay
May be technically challenging; pipetting and transfer of
small volumes
k' for delta-di-0S is small, eluting close to column void
volume which could impact accuracy; change in initial
gradient conditions should overcome this
minor(?): interference from Hyaluronic Acid, which is also
hydrolyzed by enzyme
Supporting Data
General Comments
method is well documented
amount of time to prepare samples (enzymatic
hydrolysis) and analyze samples is rather long
Method Optimization
Selectivity, Stability, Ruggedness of method meet
requirements for SMPR
May need to modify gradient to increase retention factor
(k') for delta-di-0S; currently elutes close to void volume
Performance Characteristics
Analytical Range:
0.2 - 10 ug/mL for delta-di-0S
1.4 - 70 ug/mL for delta-di-4S
2 - 100 ug/mL for delta-di-6S
LOQ:
could not find documented
Accuracy/Recovery
99.8% from liquid dietary supplement
101 - 106% in raw material and finished product
Precision (RSDr)
0.25 - 1.8% single day
Reproducibility (RSDR)
1.6 - 4.72% RSD for raw and finished product
System Suitability
5 instrument calibration standards run prior to samples,
correlation must be >0.998
Tailing factor must be within 0.8 - 1.5
Safety Review
Is the method safe to use as written?
Yes
Are there any safety concerns with
any component, instrument, reagent
or instruction of the method? If yes,
please clearly state the concerns.
No
Does the method include all
necessary safety precautions and/or Yes
CHON-004