O N E S O U R C E M U LT I - V E N D O R I Q O Q P Q

T E C H N I C A L

Qualification of HPLC & LC/MS Systems

Laboratory Instrument Qualification Performed & Documented in GLP Format
OQ Operational Qualification
Temperature accuracy and stability of column heater/cooler Holmium oxide wavelength scan (if applicable) Detector lamp intensity and wavelength accuracy Detector noise and drift Pump flow rate accuracy and repeatability High and low pressure shutdown accuracy Injector precision Detector linearity and sampleto-sample carryover Injection volume linearity Gradient composition accuracy Linear gradient tested using IPA and 0.5% Acetone/IPA Five step gradient tested using IPA and 0.5% Acetone/IPA
TEMPERATURE ACCURACY AND STABILITY OF COLUMN HEATER/COOLER

N O T E

INJECTION PRECISION Five repeated injections of standard caffeine sample. Compare area count and retention time deviations.

IQ Installation Qualification
Inventory of instruction manuals, components and serial numbers Installation verification

INJECTION LINEARITY Five injections of increasing concentrations of standard caffeine samples, followed by HPLC water injection. Compare linearity of area counts, and check for carryover in water blank.

PQ Performance Qualification
System performance and robustness Typically a 5 or 10 L injection of a low concentration sample, repeated five times Compare area count and retention time deviations For more information about OneSource multi-vendor IQ OQ PQ services, call (800) 762-4000 or e-mail us at onesource@perkinelmer.com.

INJECTION VOLUME LINEARITY 5, 10, 20, 40, and 60 L injections of standard caffeine sample. Compare linearity of area counts.

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