This method determines and calibration, the water content of low-value moisture, and calibration of Karl Fischer. To lay down the procedure for KARL FISCHER AUTO TITRATOR operation.

1.0 SCOPE:

This procedure applies to Quality Control Department.

2.0 RESPONSIBILITY

2.1 QC chemists to prepare and follow the SOP.

2.2 Head – QA & QC for implementation of SOP.

3.0 PROCEDURE

1.1 Instrument Detail:

Name	K.F.Autotitrator
Make	VEECO
Model	MATIC-MD

1.1 Operation Procedure:

4.2.1 Ensure that instrument is clean and free from dust.

4.2.2 Now fill the DRIED METHANOL up to the level to touch the sensors. Also, fill the methanol bottle and Karl Fischer reagent bottle.

4.2.1 Switch “ON” the main and start the stirring.

4.2.2 Now press the “START” button of the System to perform BLANK neutralization of Dried Methanol. After completion of Neutralization, a beep sound will appear.

Calibration of Karl Fischer

1.0 Operation Procedure for CALIBRATION (FACTOR): (Karl Fischer apparatus calibration)

1.1 Press the “CAL” button and Calibrate the instrument with DISTILLED WATER.

1.2 Press “Enter” to inject Distilled water 10μm with a syringe. After completion of the Neutralization of distilled water, a beep sound will appear.

1.3  The above process of calibration with distilled water is repeated three times.

1.4 Press the “FACTOR” button to show the Factor for calibration.

1.5 FACTOR will be above the 4.8 mg/ml. (Karl Fischer water factor limit

2.0 Procedure for Sample Testing:

Karlfischer’s Moisture Range
Expected Moisture Content (%)	Sample size (gms)
0.05	20 or more
0.1	10.0
0.5	2.0
1.0	1.0
2.0	0.5
10.0	0.1
50.0	0.02

2.1 To find out the moisture of the sample follows the above table.

1.1  Now weigh the sample and put it in the methanol beaker within the time fixed for neutralization.

1.2  After completion of Neutralization of Sample a beep sound will appear.

1.3  Now press the SAMPLE button and put the weight of the sample, then press the DENSITY button that is fixed, after that press the ppm/% button which shows the moisture of the sample on a display screen.

1.4  For closing the instrument change connection to the methanol bottle and Press the CLEAN button for cleaning the pipes with methanol.

1.5  When the pipes are cleaned press the CLEAR button close the Instrument and wash the main beaker with dried methanol.

2.0  Abbreviations:

QC              -        Quality Control

SOP           -        Standard Operating Procedure

3.0 REFERENCE: MANUAL

IPQA full form in pharma | SOP For IPQA

SOP for Cleaning and Sanitization of Colour Mixer Tank