Calibration of Karl Fischer titrator

1.0        PURPOSE: 

1.1    To lay down the procedure for Calibration of Karl Fischer titrator. 

2.0    SCOPE

2.1     This procedure is applicable for Calibration of   Karl Fischer titrator in  
          quality control department. 

3.0    RESPONSIBILITY

3.1    Assistant-QC

4.0    ACCOUNTABILITY

4.1     Sr.Executive-QC

5.0    PROCEDURE

5.1    Operate the instrument as per the respective SOP and calibrate the Karl Fischer Titrator   as follows.
    
5.1.1 ACCURACY
5.1.1.1    Determine the Karl Fischer factor (titer) taking about 30 to 50 mg of purified water, in duplicate and take the average value.
                      
5.1.1.2 Determine the water content of disodium tartarate in  duplicate by taking about 150 mg of sample using the factor as determined above. The water content thus determined     shall be between 15.5% and 16.0%                 
                      Record the details as per Format no. xxxxx
            
5.1.2    PRECISION

5.1.2.1 Determine the water content of disodium tartarate in triplicate in addition to the two determinations carried out in ACCURACY test. The %RSD of the five determinations shall be NMT 1.0. Record the details as per per Format no. xxxxx

5.1.3    LINEARITY

5.1.3.1    Determine the water content of disodium tartarate by taking 
 sample weights of 100,125,150,200 and 250 mg. Calculate the water content in mg for each determination. Plot a linearity graph of sample weight Vs volume of KF reagent consumed (ml). The correlation coefficient of the graph thus obtained shall be NLT 0.999. Record the details as per per Format no. xxxxx

5.2    FREQUENCY    :  Once in three months.   

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