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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