To calibrate the equipment for reliable and accurate results.
This procedure is applicable to calibrate the karl fischer apparatus ,installed in quality control department.
3.1 Doing : Technical Assistant
3.2 Checking : Executive/Asst. Manager
Head of the Department
5.0 ProcedureFrequency : Once in a month
5.1 Operate the instrument as per SOP.
5.2 FOR BURETTE CALIBRATION
5.2.1 Place the burette outlet in 20ml standard calibrated measuring cylinder.
5.2.2 Dispense 2,4,6,8,10,12,14,16,18 & 20 ml water into previously weighed & conditioned beaker and note the water weight of water for the dispensed.5.2.3 Note down the observed volume of water in the measuring cylinder.
5.2.4 Record the obtained volume and displayed volume in the enclosed format.
5.2.5 The volume displayed on instrument and the volume collected in cylinder should not vary by more than 0.5 %, other wise follow the S.O.P.
5.2.6 Record the results in Annexure.
5.2.7 Frequency of calibration : Once in a month.
5.3 FOR INSTRUMENT PERFORMANCE
5.3.1 Add accurately weighed 50mg, 100mg, 150mg, 200mg, 250mg of Disodium tartrate into the titration vessel containing neutralized methanol and test for water content.
5.3.2 Calculate the % water by using the formula given below.
Volume of KFR consumed in ml X 100 X Factor
% Water (W/W) = --------------------------------------------------------------
Weight of disodium tartrate in mg
5.3.3 The performance of the instrument is satisfactory if the difference between the obtained values are within the tolerance limit of 15.66 ± 5% i.e. 14.87% -16.44.
5.3.4 Record the results in Annexure-I.
5.3.5 Frequency of calibration : Once in a month.
6.1 % = Percentage
6.2 mg = milligram
6.3 W/W = Weight by Weight
6.4 S.O.P. = Standard operating procedure
6.5 ml = mililiter
6.6 KFR = Karl fischer reagent
Q. C. Department
Q. C. Department
PERFORMANCE CHECK REPORT OF KARL FISCHER APPARATUS
PERFORMANCE CHECK DATE
DATE OF LAST PERFORMANCE
NEXT DUE FOR
INSTRUMENT ID No.
Wt. taken of di-sodium tartrate
Volume of KFR required
% Water obtained
14.87 % to 16.44 %
Linearity : ____(NLT 99.00%)
% RSD :
(NMT 1.0 %)
BURETTE CALIBRATION :
Actual temp of water : ________
Factor : ________
Wt. of beaker (A) : _________
Wt. of beaker + water
Wt. of water
Actual volume (ml)
(Factor X D)
Tolerance + 0.5 % of displayed volume
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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