SPDS Set 1 ERP Book

PDE5-003

Low throughput, only applicable to the analytes that can be ionized at the condition used. In this case, only ESI positive mode was used. Supporting Data There are details in this work about the QC, data analysis, and how to use the method with other techniques such as NMR to fully characterize other unknowns etc. The figures and tables are clear. There are some inconsistencies with the parameters in the method description and in the appendix, such as mass spectral acquisition parameters. The method optimization is not specifically discussed; however,the method description indicated that optimization was performed based on the recommended solvent selection for the extraction of the analytes and also the recommend fragmentation parameters etc. of mass spectrometer. Performance Characteristics

Cons/Weaknesses

General Comments

Method Optimization

Analytical Range:

1ug to 5 ug/mL.

LOQ:

Not applicable as a qualitative method

Accuracy/Recovery

Not applicable as a qualitative method

Precision (RSDr)

Not applicable as a qualitative method

Reproducibility (RSDR)

Not applicable as a qualitative method

It is not specifically discussed. Running standards before running the samples will fulfil part of this requirement. 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. 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 yes

No extra safety concern is identified.