Calibration of KARL FISCHER (METTLER TOLEDO)

November 26, 2019January 29, 2023 Pharma Editor

OBJECTIVE
To lay down the procedure for CALIBRATION of KARL FISCHER (METTLER TOLEDO)
SCOPE
To ensure that the instrument performs satisfactory and gives accurate and reproducible data. This SOP shall be applicable for the KARL FISCHER APPARATUS (METTLER TOLEDO).
RESPONSIBILITY
Quality Control Executive/Officer.
ACCOUNTABILITY
Quality Control Manager.

PROCEDURE

FOR CLEANING
Check that the power supply to the instrument is switched ‘ OFF ‘ before cleaning. Clean the instrument with a clean dry cloth every day. Occasionally wet cloth dipped in dilute soap solution may be used. Precaution has to be taken to clean the instrument immediately with dry cloth to remove the moisture.
OPERATING INSTRUCTIONS

Check that the instrument is properly connected to the power supply.

Operate the apparatus as per procedure No. BA(II)QA222.

Transfer accurately about 100mg of disodium tartrate in to the titration vessel and find out the K.F.

Repeat the experiment in duplicate and feed the average of these two readings of KF factor in memory by pressing the <Setup> key of the instrument.

Weigh accurately 150 mg of Di Sodium Tartrate in Titration vessel and find out the % of water present in Di Sodium Tartrate with the help of K.F. Reagent.

Repeat the experiment in triplicate and find out the % of water content in Disodium Tartrate. The presence of water should be between 15.6 to 15.7 %. Record the observation in the table

Fill the details of the calibration status in the label pasted on the Instrument / Apparatus.

Repeat any discrepancy observed during calibration to Quality Control Manager and notify the defect to engineering department or Service Engineer of the instrument. Affix an Under Maintenance label on the

Frequency of calibration: Once in a month.

Reference IP 1996

Forms and Records (Annexures)
Not Applicable
Distribution
Master copy – Quality Assurance
Controlled copies- Quality Assurance, Production, Quality Control.engineering
History

Date Revision Number Reason for Revision

– 00 New SOP

Date	Revision Number	Reason for Revision
–	00	New SOP

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