36 / 116
LOQ:
Not provided
Accuracy/Recovery
Spike recovery: 102.5-103.6% at three spike levels (50, 100
and 150%). The number of repeated spikes is not reported
Precision (RSDr)
The results of 5 sample preparations in two laboratories
were provided. The overall RSDn is 7.11 and that is larger
than required in the SMPR
Reproducibility (RSDR)
System Suitability
NA
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 warning statements? Yes or
No. If No, please suggest potential
precautions or warnings that can
be added to the method for users
or recommend safer option(s) if
warranted.
Yes
Recommendations
Final Recommendation:
The method as written is applicable for the analysis of raw
materials and simple finished products . The method
doesn't meet the Method Performance Requirements
stated in the SMPR, but these might be improved after
further method development/optimization. Depending on
the quality of the other submission this method can be a
candidate for further consideration.
CHON-003