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%