1.0 OBJECTIVE:To lay down the procedure for operation of Karl Fischer apparatus.
2.0 SCOPE:This SOP shall be applicable to Quality Control Dept.
3.0 RESPONSIBILITY:Quality Control Supervisor
4.0 ACCOUNTABILITY:Sr. Manager Quality Assurance
5.0 PROCEDURE:5.1 Take about 150 ml of Karl Fischer reagent. The glassware used should be well dried as otherwise the reagent will become useless due to moisture.
5.2 Put the Karl Fischer reagent in the reservoir bottle provided at the back and place the stopper immediately after addition of Reagent.
5.3 Remove large rubber cork and add some methanol to the moisture beaker to such an extent that the metal wires of the sensors in the beaker are fully immersed. Replace the cork immediately.
5.4 Connect leads of relay to the small three-pin socket on the titrator. Then connect the sensor wires to socket provided on the instruments. Adjust speed of the magnetic stirrers such that the wired ends of the sensor do not touch the stirred and at the same time sensors should not be exposed to air.
5.5 Put the dispensing burette on top of Karl Fischer Reagent bottle and close it properly.
5.6 Connect the titrator to main supply. Veego Home screen will be displayed.
5.7 Rotate Stirrer knob provided on Right side of instrument. Stirrer will be on.
Adjust the speed of the magnetic stirrer in such a way that the wired ends of the sensors do not touch the stirrer and at the same time sensors should not be exposed to air.
5.8 Press Start key. Instrument Starts calculating and neutralizing the water previously present in the methanol by adding Karl Fischer reagent. Once methanol is neutralized repeat the same procedure till KF reading for methanol comes to zero.
5.9 Weigh the sample for water content is to be determined. Press start key and add sample to methanol for water determination .KF reading will be displayed.
5.10 Press “Smpl” key and add weight of sample taken for analysis.Press enter key and then “%age, PPM, mgH2O” key to display water content present in the sample.
6.0 ABBREVIATIONS:6.1 SOP : Standard Operating Procedure
6.2 QA : Quality Assurance
6.3 QC : Quality Control
6.4 Dept. : Department
6.5 KF : Karl Fischer
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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