Karl Fischer titrator ezFiSCHR: Accurate moisture determination and 21 CFR Part 11 compliance

Determining water content is a critical quality parameter in countless industries, from pharmaceuticals and food to petrochemicals. The ezFiSCHR Karl Fischer titrator by Electrolab is a modern, voltametric titration system, specifically designed for the fast, accurate, and repeatable quantification of water, while fully complying with the stringent regulations of the pharmaceutical industry.

Superior features of the ezFiSCHR Karl Fischer titrator

This product integrates advanced technology and intelligent software to provide a comprehensive moisture determination solution.

Full 21 CFR Part 11 compliance for the pharmaceutical industry

Equipped with ezIntegrity software, the ezFiSCHR fully meets the requirements of 21 CFR Part 11 for electronic records and signatures. Features like user management, audit trails, and secure reports ensure data integrity, a mandatory requirement for labs submitting data to the FDA.

Specialized dosing system for Karl Fischer analysis

The ezFiSCHR employs voltametric endpoint detection with a dedicated Karl Fischer electrode, ensuring high sensitivity and accuracy in water detection. The efficient dosing assembly, with a 5 μL burette resolution and smart burette recognition, eliminates errors and optimizes the workflow.

Intuitive and smart touchscreen interface

A 7-inch capacitive touchscreen with a user-friendly graphical interface allows users to easily set up methods, monitor the titration process, and manage data. With the capacity to store 1000 methods and reports, along with customizable calculation formulas, the ezFiSCHR offers maximum flexibility.

Detailed technical specifications

• Model: ezFiSCHR

• Principle: Voltametric Karl Fischer Titration

• Endpoint detection: Voltametric

• Sensor: Karl Fischer electrode

• Burette resolution: 5 μL

• Burette capacity: 20 mL

• Display: 7-inch capacitive touchscreen

• Storage: 1000 Reports & Methods

• Compliance: ezIntegrity software (21 CFR Part 11)

• Communication Interface: Ethernet/Wifi (PC), Ethernet/USB (Printer), USB (External drive)

Frequently asked questions (FAQ)

1. What is Karl Fischer titration?
It is a specialized chemical titration method and is considered the “gold standard” for determining the water content in a solid, liquid, or gaseous sample. It is based on the reaction of iodine with water.

2. How is this instrument different from potentiometric titrators like the ezTiTRATR?
The core difference lies in the principle and application. The ezFiSCHR uses a voltametric method specifically to determine water content. In contrast, potentiometric titrators measure the change in potential (mV) or pH to determine the concentration of a substance in acid-base, redox, or other reactions.

3. Why is 21 CFR Part 11 compliance important for a Karl Fischer titrator?
Because water content is a critical batch release parameter in the pharmaceutical industry, ensuring that the measurement data is accurate, secure, and unalterable is a mandatory requirement from regulatory bodies like the FDA.

4. What kinds of samples can it analyze?
A Karl Fischer titrator can analyze the water content in a wide range of samples, including pharmaceuticals, chemicals, solvents, oils, foods, and many other industrial products.

5. How is the endpoint of the titration detected?
The instrument uses a voltametric method. A small current is applied across a dual platinum electrode. In the presence of water, the iodine in the reagent is consumed. At the endpoint, when a slight excess of iodine is present, it causes a sudden voltage drop, which the instrument registers as the end of the titration.