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