Verification For Quantitative Test Methods

Transcription

1 Verification For Quantitative Test Methods Purpose To show the instrument is fit for use after replacing column 1 (new SN ) and updating the analyte retention times. Analyte Units of Measure Analyst Performing Responsible Supervisor Ethanol, Methanol, Acetone, Isopropanol g/100 ml Corissa L. Rodgers, M.S. Dayong Lee, Ph.D. Start Date December 14, 2016 Completion Date December 14, 2016 Primary Matrix Secondary Matrices Whole Blood Serum, Plasma, Alcoholic Beverages, Other Liquid Specimens Low Calibrator Concentration Highest Calibrator Concentration Equipment/Instrument Instrument Serial Number Method (Ethanol), (Methanol, Acetone, Isopropanol) Headspace 2 This instrument is fit for use on casework for Alcohol and Other Volatiles Analysis. Headspace CN Gas Chromatograph CN VOLATILES Verification Report Date December 15, 2016 Verification Approval Analyst: Date Responsible Supervisor: Date

2 Analyte: Ethanol Run Date Run Order MQC1 BQC2 EQC LMQC Target Concentration (g/100 ml): Run Dec _CLR Within Run Mean SD %CV 0.528% 0.419% 0.611% 0.000% % Bias -0.42% 0.12% 0.96% 3.13% ; BQC2 (Lot: ); EQC (Lot: B) Section Analytical Manual Standard Operating Procedures Version 2.6. Analyte: Ethanol Run Date Run Order MQC1 BQC2 EQC LMQC Target Concentration (g/100 ml): Run Dec _CLR Within Run Mean SD %CV 0.652% 0.480% 0.500% 0.000% % Bias -0.59% 0.82% 1.08% 3.65% ; BQC2 (Lot: ); EQC (Lot: B) Section Analytical Manual Standard Operating Procedures Version 2.6.

3 Analyte: Methanol Target Concentration (g/100 ml): Run Dec _CLR Within Run Mean SD %CV 0.735% 0.505% % Bias -1.37% 3.13% Analyte: Methanol Target Concentration (g/100 ml): Run Dec _CLR Within Run Mean SD %CV 1.136% 0.582% % Bias 0.37% 3.30%

4 Analyte: Isopropanol Target Concentration (g/100 ml): Run Dec _CLR Within Run Mean SD %CV 0.256% 0.774% % Bias -0.26% 2.78% Analyte: Isopropanol Target Concentration (g/100 ml): Run Dec _CLR Within Run Mean SD %CV 0.390% 0.000% % Bias 0.17% 2.60%

5 Analyte: Acetone Target Concentration (g/100 ml): Run Dec _CLR Within Run Mean SD %CV 0.682% 0.295% % Bias 0.78% 1.91% Analyte: Acetone Target Concentration (g/100 ml): Run Dec _CLR Within Run Mean SD %CV 0.734% 0.295% % Bias 0.85% 1.91%

6 Instrument: Headspace 2 Deviations from SOP: SUMMARY OF VERIFICATION PERFORMANCE Study Dates: 12/14/16 to 12/14/16 None. Other Notes: After replacing the front column, retention times were updated. This was accomplished by finding the average retention time per analyte across all calibration levels, updating the calibration table for each analyte, and reprocessing all data with the updated calibration table. Following this successful verification, the master VOLATILES.M calibration table will also be revised to reflect the updated analyte retention times. Conclusion: Headspace 2 is fit for use on casework analysis of ethanol, methanol, isopropanol and acetone after maintenance.