SPDS Set 1 ERP Book

PDE5-005

of drugs to obtain structurally significant fragment ions Performance Characteristics

Analytical Range:

0, 100, 1000 mg/kg

LOQ:

N/A

Accuracy/Recovery

Recoveries of a 50 ppm spike ranged from 69% to 90%.

Precision (RSDr)

Repeatability values obtained were 0.4-1.8%.

Reproducibility (RSDR)

N/A

System Suitability

Not addressed in method. 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

Method is recommended for approval for screening, identification and quantitation with reservation due to expensive, highly technical instrumentation employed.

Final Recommendation: