Title: Standard operating procedure for determination of Moisture content by volumetric Karl Fischer method.


1.0                   OBJECTIVE:

To lay down a procedure for determination of Moisture content by volumetric Karl Fischer method.

2.0                   SCOPE:

This SOP shall be applicable to Q.C Dept.

3.0                   RESPONSIBILITY:

3.1    Doing: Q.C Analyst.

3.2    Checking: Q.C-Manager.

4.0                   ACCOUNTABILITY:

4.1    Head of the Q.C Department.

5.0                   MATERIAL AND EQUIPMENT:

5.1    Karl Fischer apparatus.

5.2    Weighing balance.

5.3    Methanol.

5.4    Karl Fischer reagent.

5.5    Glassware (according to need).

5.6    Sample

6.0                   PROCEDURE:

6.1    Operate the Karl Fischer apparatus according to SOP.

6.2    Unless otherwise specified, take a dried titration flask of apparatus and add 35 to 40ml of methanol in it and titrate it with Karl Fischer reagent to the end point.

6.3    Weigh accurately test specimen by using analytical weighing balance.

6.4    Quickly add it in titration flask and mix by using magnetic stirrer.

6.5    And titrate the solution with Karl Fischer reagent to the end point under vigorous stirring.

6.6    When the sample is insoluble in the solvent, powder the sample, weigh suitable amount and transfer it quickly into titration flask, stir the mixture for 30 minutes while protecting it from moisture. Perform titration under vigorous stirring.

6.7    The results will be appeared on the screen of apparatus.

6.8    % Water content can be determined by using formula:

% Water content = volume of Karl Fischer reagent consumed (ml) x factor (mg/ml) x100

Weight of sample (mg)

7.0                   REVISION LOG:

Revision No.

Effective Date






8.0                   REFERENCES:

8.1    Not Applicable.

9.0                   ANNEXURES:

9.1    Not Applicable.