SPDS Set 1 ERP Book

PDE5-001

The method is miniaturized which allows high throughput for samples. Sample preparation is easy and simple. The linearity for the three compounds studied is excellent, they are linear from 50 to 1000 ppm in the sample. The consumables are inexpensive. The cost of the DART itself, compared with other DART instruments on the market, is reasonable. It would still need a highly skilled operator for the instrument. The method could be a little clearer. Extraction times, drying times, etc., were not mentioned. The data at the end of the method could have been organized a lot better. It was a little difficult to follow. Also, an explanation of how the RSD's were produced would have been helpful. small sample size, easy extraction, use of internal standards for quantitation, ease of automation, use of MS/MS for selctivity and sensitivity, low maintenance. The data is rather confusing in order to find out if the 10 replicates are taken form the same extract or are from 10 different extracts. This will need to be cleared up. The method appears to be optimized for three target compounds not the entire list in the SMPR. There is also no optimization data for the nontargeted panel. Performance Characteristics 50 - 1000 ppm, unsure if this is applicable when a POD model is used. none stated, uses a ratio of target to internal standard which is 0.100 to be considered positive. There were some recovery studies done, but it is unclear how they were calculated. Needs the use of a highly skilled operator. Supporting Data

General Comments About the Method:

Method Clarity

Pros/Strengths

Cons/Weaknesses

General Comments

Method Optimization

Analytical Range:

LOQ:

Accuracy/Recovery

Precision (RSDr)

It is unclear how this was calculated.

Reproducibility (RSDR)

It is unclear how this was calculated.

System Suitability

Does not appear to be addressed. Safety Review

Is the method safe to use as written? Yes