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SOP for Performance Checks of Karl Fischer Apparatus


Standard operating procedure to calibrate the karl fischer apparatus using disodium tartrate.

1.0  Objective

       To calibrate the equipment for reliable and accurate results.

2.0  SCOPE

       This procedure is applicable to calibrate the karl fischer apparatus ,installed in quality control department.

3.0  Responsibility

3.1  Doing      : Technical Assistant
3.2  Checking : Executive/Asst. Manager    

4.0  Accountability

       Head of the Department  

5.0  Procedure

       Frequency : 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.

6.0  ABBREVIATIONS

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


ANNEXURE-I
Q. C. Department
PERFORMANCE CHECK REPORT OF KARL FISCHER APPARATUS
            
PERFORMANCE CHECK  DATE

DATE OF LAST PERFORMANCE
CHECK DONE
NEXT DUE FOR
PERFORMANCE CHECK






INSTRUMENT DETAILS
INSTRUMENT NAME
INSTRUMENT MAKE
INSTRUMENT ID No.




OBSERVATION

Sr. No.
Wt. taken of di-sodium   tartrate
(mg)
Volume of KFR required
(ml)
Factor
mg. H2O/ml
% Water obtained
Tolerance
1




14.87 % to 16.44 %
2




3




4




5





Linearity : ____(NLT 99.00%)
% RSD :


(NMT 1.0 %)

Calculation :
BURETTE CALIBRATION :
Actual temp of water   : ________
Factor                          : ________
Wt. of beaker (A)        : _________

Sr. no.
Displayed volume
(ml)
B
Wt. of beaker + water
(gm)
C
Wt. of water
(gm)
D=(C-A) gm
Actual volume (ml)
E=
(Factor X D)
difference

F=(E-B)
Tolerance + 0.5 % of displayed volume
1






2






3






4






5






6






7






8






9






10







Calculation :
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.
Email: .moc.enilediugamrahp@ofni Need Help: Ask Question


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