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 |
Reason |
|
00 |
|
New
SOP |
8.0
REFERENCES:
8.1
Not Applicable.
9.0
ANNEXURES:
9.1 Not Applicable.