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:
Made with FlippingBook