The document provides acceptance criteria for calibrating and testing an HPLC system in-house. It lists parameters like pump flow rate accuracy, temperature calibration ranges, and tests for injection precision, linearity, and carryover. Proper balancing, connections, downloads, and performance checks are needed to verify the HPLC system is functioning correctly before use.
The document provides acceptance criteria for calibrating and testing an HPLC system in-house. It lists parameters like pump flow rate accuracy, temperature calibration ranges, and tests for injection precision, linearity, and carryover. Proper balancing, connections, downloads, and performance checks are needed to verify the HPLC system is functioning correctly before use.
The document provides acceptance criteria for calibrating and testing an HPLC system in-house. It lists parameters like pump flow rate accuracy, temperature calibration ranges, and tests for injection precision, linearity, and carryover. Proper balancing, connections, downloads, and performance checks are needed to verify the HPLC system is functioning correctly before use.
The document provides acceptance criteria for calibrating and testing an HPLC system in-house. It lists parameters like pump flow rate accuracy, temperature calibration ranges, and tests for injection precision, linearity, and carryover. Proper balancing, connections, downloads, and performance checks are needed to verify the HPLC system is functioning correctly before use.
Download as XLSX, PDF, TXT or read online from Scribd
Download as xlsx, pdf, or txt
You are on page 1/ 3
HPLC IQ & IN-HOUSE CALIBRATION PARAMETERS
SR.NO PARAMETER ACCEPTANCE CRITERIA REMARK
1 BALANCING OF HPLC AT NEW PLATFORM SHOULD BE PROPERLY BALANCED 2 PHYSICAL CONDITION NO PHYSICAL DAMAGE ELECTRIC SUPPLY SHOULD BE SWITCHED ON AFTER 3 POWER SUPPLY 4 CONNECTION WITH PC MUST CONNECT WITH PC SOFTWARE LOGIN USER LOGIN SHALL BE DONE IN 5 SOFTWARE
ALL ICONS SHOULD BE VISIBLE AS
ALL ICONS CHECK IN SOFWARE BEFORE Eg. Instrument, browser, 6 postrun Method download Method present in system should be 7 downloaded at once 8 Purging Method run Auto purge should start 9 MOCK BATCH TABLE CREATION BATCH TABLE IN - HOUSE CALIBRATION OF HPLC 1 PUMP PERFORMANCE 0.5 ml/min - 0.475 ml to 0.525 ml 1.0 ml/min - 0.950 ml to 1.050 FLOW RATE ACCURACY - 0.5ml/min, 1.0ml/min ml 2.0mlml/min 1.900 ml to 2.100 (i) & 2.0 ml/min from A,B,C & D channels ml (ii) GPV TEST AT 10% - 9 TO 11% AT 50% - 49% TO 51% A/B AT 90% - 89% TO 91 % (ii a) AT 10% - 9 TO 11% AT 50% - 49% TO 51% A/C AT 90% - 89% TO 91 % (ii B) AT 10% - 9 TO 11% AT 50% - 49% TO 51% A/D AT 90% - 89% TO 91 % (ii C) % RSD OF AREA OF 6 INJECTION NMT 2.0% FLOW PRECISION AND INJECTOR PRECISION % RSD OF RETENTION TIME OF 6 INJECTION NMT 2.0% 2 VIAL PUNCTURED TEST THE RESPECTIVE VIAL SHALL BE 3 PUNCTURED TEMPERATURE CALIBRATION FOR COLUMN THE OBSERVED TEMP SHALL BE WITHIN 4 OVEN + 2°C OF THE SET VALUE TEMPERATURE CALIBRATION FOR SAMPLE 5 COOLER AT 15°C 13°C - 17°C INJECTION VOLUME ACCURACY 10,20,50,100 6 ul ± 1 ul of set value 7 INJECTOR LINEARITY Correlation cofficient NLT 0.999 8 AUTOSAMPLER CARRY OVER TEST NMT 0.1%
