SPDS Set 1 ERP Book

CHON-004

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 method is well documented amount of time to prepare samples (enzymatic hydrolysis) and analyze samples is rather long 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

General Comments

Method Optimization

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

Analytical Range:

LOQ:

could not find documented

99.8% from liquid dietary supplement 101 - 106% in raw material and finished product

Accuracy/Recovery

Precision (RSDr)

0.25 - 1.8% single day

Reproducibility (RSDR)

1.6 - 4.72% RSD for raw and finished product

5 instrument calibration standards run prior to samples, correlation must be >0.998 Tailing factor must be within 0.8 - 1.5 Safety Review

System Suitability

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