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21 CFR Part 11 Compliant Karl Fischer Titrator – Kafi Smart

21 CFR Part 11 Compliant Karl Fischer Titrator – Kafi Smart

Karl Fischer titration is an accurate, rapid and efficient method for determining the water content in samples.

When the sample is titrated in the presence of SO, I2 and organic base, moisture from the sample extracted in the solvent, can be quantitatively estimated. Dry methanol is used as a solvent in Karl Fischer titration.

The indicator-electrode is a two – pin platinum electrode across which a constant current is generated by a polarizing current source. For starting, very low volume of methanol as a needed in the specially designed vessel.

Background signal correction is done through an offset mode.

Calculated doses of Karl Fischer regent are added to the solution in a hermetically sealed vessel as per stop criteria selected and the end-point volume is evaluated automatically. The instrument continuously monitors moisture leak in the vessel and neutralizes it automatically.

The built-in reagent standardization procedure by water (H2O) or Sodium Titrate (C4H4Na2O62H2O) for titre factor / concentration (F) is incorporated.

The liquid handling path comprises Teflon tubing, Teflon-lined valve, and a gastight syringe with Teflon plunger. It creates a chemically inert system for this highly sensitive analysis.

The magnetic, adjustable- speed stirrer is a part of the system in which the sample is stirred vigorously to extract the moisture efficiently.

The result, including the leak rate, is printed in a tabulated form and is also displayed on back lighted liquid crystal display (LCD) screen.

Modes of Operation:

Karl Fischer Titration is a dead stop titration process which monitors the mV drift to be lower than the stop band, and end of the titration is detected when the leak rate is close to or less than stop band. The leak rate is displayed and also printed.

There are two main modes of operation:

  • In minimum ‘Dose Mode’ where the end dose is same as the minimum dose, the titration will be stopped when mV does not rise above the stop band in specific delay time.
  • In drift mode, the titration will be stopped if the calculated drift value is less than or equal to entered drift value in µl/min.

Calculation Modes:

  • Weight/weight
  • Volume/volume
  • Volume/density

Selectable Report formats, complying with GLP requirement:

  • Report giving titration parameters and result.
  • Report of method Parameters.
  • Condensed report of titration parameter and result
  • Statics report for last 10 repeat run analysis

Report can be obtained even after resetting / power off/ power failure conditions.

Key Features:

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