SPDS Set 1 ERP Book

CHON-003

LOQ:

Not provided

Spike recovery: 102.5-103.6% at three spike levels (50, 100 and 150%). The number of repeated spikes is not reported 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

Accuracy/Recovery

Precision (RSDr)

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. 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.

No

Yes

Recommendations

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.

Final Recommendation: