DETERMINATION OF KF FACTOR

1. PROCEDURE:

           Note:

1. Operate the KF titrator using suitable operating procedure.
2. A commercially available, stabilized solution of Karl Fischer type reagent may be used. Commercially available reagents containing solvents or bases other than pyridine or alcohols other than methanol may be used also.
3. The diluted Reagent called for in some monographs should be diluted as directed by the individual testing procedure. Either methanol or other suitable solvent, such as ethylene glycol monomethyl ether, may be used as the diluent. The same solution shall be standardized.

           Standardization of KF Reagent by Water:    

1. Unless otherwise specified, transfer 35 to 40 mL of methanol or other suitable solvent to the titration vessel.
2. Neutralise the solvent with KF reagent.
3. Weigh accurately between 25 to 250mg of water, transfer it into the titration vessel.
4. Titer the content with Karl Fischer reagent to end point to the electrometric or visual endpoint.
5. Perform the above titration in duplicate.
6. Calculate the Factor using the formula

                                               Weight of water taken in g x 1000

                           Factor =    --------------------------------------------------

                                              Volume of KF reagent consumed in mL 

           Standardization of KF Reagent by disodium tartrate:        

1. Unless otherwise specified, transfer 35 to 40 mL of methanol or other suitable solvent to the titration vessel
2. Neutralise the solvent with KF reagent.
3. Weigh accurately 75 to125mg of Disodium tartrate , transfer it into the titration vessel
4. Titer the content with Karl Fischer reagent to end point to the electrometric or visual endpoint.
5. Perform the above titration in duplicate.
6. Calculate the Factor using the formula

                                  2 x 18.02 x Weight of Disodium tartrate taken in g x 1000

                     Factor =    -------------------------------------------------------------------------

                                             230.08 X Volume of KF reagent consumed in mL 

           Acceptance criteria:

1. Standardization is valid, if concentration should be not less than 5 mg and not more than 7mg
2. The relative Standard deviation between two average KF factors of water and DST determined consecutively should not be more than 3.0 % [Average of two factors (2 with water and 2 with DST) to be considered for calculation.]

Neutralise, ethylene glycol monomethyl ether, pyridine, alcohols