Which titrator supports 21 CFR Part 11 compliance?

Metrohm’s Ti-Touch and OMNIS titrators offer audit trails, user management, and secure data handling for full regulatory compliance to 21 CFR Part 11. Stand-alone titrators (without PC software): Ti-Touch Software-controlled titrators: OMNIS

How do titrators work?

Titrators are used to determine the concentration of a substance (analyte), which is dissolved in a sample. A reagent (titrant) is added gradually in a known volume to the sample until a chemical reaction reaches its endpoint, which is detected by a sensor. How titrators work step-by-step: Sample addition: The sample is added to a vessel, often with a stirrer to ensure homogeneity. Titrant addition: The titrant is added manually or automatically in controlled volumes. Measurement & monitoring: Sensors continuously monitor the reaction. The titrator tracks changes in solution properties (e.g., voltage, color, conductivity) to detect the equivalence point. Endpoint detection: The endpoint is the moment when the reaction is complete. Result calculation & reporting: The titrator calculates the concentration of the analyte based on the volume of titrant used and generates a digital report. Various sensors are available to monitor the reaction depending on the type of titration you are performing. Metrohm offers sensors for photometric, thermometric, redox, precipitation, complexometric, surfactant, aqueous or non-aqueous acid-base titration. Check out our Webinar Center and our blog to learn more about titration: Webinar: Basics of titration Blog: Titration – definition and principles Blog: Best practices for electrodes in titration

Does the entry-level titrator have good accuracy?

Yes, entry-level Metrohm titrators (i.e., Eco Titrators ) deliver reliable accuracy when paired with proper electrodes and validated methods. The accuracy of titrations does not only depend on the instrument, it is the sum of several factors that contribute to it: Choice of a suitable electrode or indication method Choice of a suitable cylinder volume Choice of a suitable titration mode Accuracy of sample size (weighing/pipetting) Homogenization of the sample Electrode cleaning and maintenance Burette maintenance Other factors, depending on the specific titration method An overview on how to get correct and accurate titration results can be found here: Blog: How to avoid titration errors in your lab Blog: Validation of titration methods Webinar: Avoid titration mistakes through best practice sensor handling Webinar: Troubleshooting titration: essential know-how for quality results

How do I validate a titration method?

Validating a titration method ensures that the procedure delivers accurate, reproducible, and reliable results – especially when transitioning from manual to automated titration. Metrohm recommends following the validation framework outlined in USP General Chapter <1225> Validation of Compendial Procedures and ICH Guidance Q2(R1) Validation of Analytical Procedures: Text and Methodology , which includes the following key steps: Perform standardization of the titrant using a primary standard or a pre-standardized solution Assess the accuracy and precision of the titration results by performing reference measurements Verify the linearity of your results, i.e., that the titration results are proportional to the analyte concentration across the expected range Demonstrate specificity , i.e., that the method can accurately measure the analyte without interference from impurities, excipients, or degradation products. Find more information: Blog: Validation of titration methods White paper: Recommendations for titration methods validation

What are the benefits of an autotitrator?

Titration is one of the oldest analytical techniques and is usually performed manually. However, manual titration presents many challenges. An autotitrator automates the titration process, delivering faster, more accurate, and safer results compared to manual titration. The video summarizes the 5 top reasons to switch from manual to automated titration. Easier preparation of the buret: An autotitrator fills the buret automatically. Step-by-step guidance: An autotitrator automatically transfers the sample size from the balance to the software or instrument, adjusts the stirring speed, and more. More reliable and reproducible endpoint evaluation: Automatic titrators ensure objective endpoint detection. Complete documentation according to GxP: Autotitrators ensure compliance with FDA CFR Part 11 and EudraLex Vol. 4, Annex 11. Safer handling of chemicals: Autotitrators reduce the exposure to hazardous chemicals. In summary, the main benefits of an autotitrator are: Speed and throughput: Faster analysis and higher sample throughput Accuracy and reproducibility: Automated dosing and endpoint detection minimize human error Efficiency: Frees lab personnel from repetitive tasks Safety: Minimizes chemical exposure Data management: Digital reports and integration with LIMS/ERP systems Scalability: Modular accessories and automation options adapt to changing workloads Learn more about autotitrators: White Paper: Manual vs. Automated Titration: Benefits and Advantages to Switching Webinar: The benefits of automating your titration applications Blog: Why consider automation – even for simple titrations Blog: How to transfer manual titration to autotitration

What should I consider when choosing a titrator?

Choosing the right titrator depends on your sample type, analytical goals, and lab environment. Here are the key factors to consider: Factors Tips Type of titration Potentiometric titration: Ideal for acid-base, redox, complexometric, and precipitation reactions. Photometric: Suitable for colored, opaque, or non-aqueous samples. Thermometric titration: Best for samples where traditional sensors may not work. Conductometric titration: Useful for reactions involving ionic changes. Sample characteristics Consider whether your samples are liquids, solids, slurries, or gases. Some titrators offer accessories like homogenizers or sample preparation modules to handle complex matrices. Throughput & automation For high sample volumes, look for titrators with autosamplers or robotic automation (e.g., Metrohm’s OMNIS Sample Robot ). Parallel titration capabilities can significantly boost lab efficiency. Accuracy & reliability Choose systems with precise dosing, sensitive sensors, and robust endpoint detection. Look for instruments that support method validation and reproducibility. Compliance & data management Ensure compatibility with GLP/GMP, 21 CFR Part 11, and other regulatory standards. Check for integration with LIMS, ERP, or ELN systems for traceability and audit readiness. Modularity & scalability Opt for a platform that grows with your lab. Metrohm’s OMNIS titrators allow expansion with additional modules and titration modes. Support & service Consider availability of training, application support, and service contracts. Ask about software updates, warranty coverage, and repair turnaround times. Our titration experts are happy to assist you with your questions: Contact us

Titrering

Innovative titratorer, titreringssystemer, tilbehør og ekspertise fra verdens ledende leverandør av titreringsløsninger.

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Vår portefølje av titratorer inkluderer rimelige, kompakte og frittstående alternativer samt moderne og helautomatiserte systemer. Bruk filtrene til å avgrense søket ditt og finn den perfekte titratoren.

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Markedsledende titreringsløsninger

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Metrohm – Verdensledende leverandør av banebrytende instrumenter og løsninger for dine titreringsanalyser.

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Recognition of endpoints (EP)

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How to avoid titration errors in your lab

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Fem grunner til å bytte fra manuell til automatisert titrering

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Validation of titration methods

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Basics of titration

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Reliable and accurate measurements – Components for your titrator

Electrodes

Our range of hand-made electrodes covers pH, redox, and precipitation titrations, and more. Find the electrode you need with the Electrode Finder.

Accessories

Find all titration equipment and accessories you need for your titrations with the Accessory Finder: Sample beakers, adapters, titration heads, sample racks, tubing, and more.

OMNIS Software

Learn more about our modular and powerful lab data management software OMNIS. Optional features include 3rd party data integration, long-term support, compliance package, or a networkable client/server version.

Why Metrohm titrators? – We are the global market leader

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Founded in 1943, Metrohm has developed into the world-leading provider of cutting-edge instruments and solutions for titration analyses.

Get the complete range of titrators, from compact benchtop solutions to modular autotitrator systems including accessories and software for potentiometric titration, volumetric and coulometric Karl Fischer titration, or process analysis from one supplier.
Rely on Swiss-made quality.
Benefit from our global presence in over 80 countries for local support by our service and application experts.

Over 450 application notes on titration written by our application specialists are waiting to be read:

Go to Application Finder

Go to our solutions for Karl Fischer titration and process analysis:

Karl Fischer titrators from Metrohm

Titration process analyzer from Metrohm

Titrator – FAQs

Titrators are used to determine the concentration of a substance (analyte), which is dissolved in a sample. A reagent (titrant) is added gradually in a known volume to the sample until a chemical reaction reaches its endpoint, which is detected by a sensor.

How titrators work step-by-step:

Sample addition: The sample is added to a vessel, often with a stirrer to ensure homogeneity.
Titrant addition: The titrant is added manually or automatically in controlled volumes.
Measurement & monitoring: Sensors continuously monitor the reaction. The titrator tracks changes in solution properties (e.g., voltage, color, conductivity) to detect the equivalence point.
Endpoint detection: The endpoint is the moment when the reaction is complete.
Result calculation & reporting: The titrator calculates the concentration of the analyte based on the volume of titrant used and generates a digital report.

Various sensors are available to monitor the reaction depending on the type of titration you are performing. Metrohm offers sensors for photometric, thermometric, redox, precipitation, complexometric, surfactant, aqueous or non-aqueous acid-base titration.

Check out our Webinar Center and our blog to learn more about titration:

Webinar: Basics of titration

Blog: Titration – definition and principles

Blog: Best practices for electrodes in titration

OMNIS, OMNIS titrator, OMNIS dosing module, OMNIS titration module, titration

An automatic titrator is a laboratory instrument that performs titration procedures automatically, including sample and titrant addition, endpoint detection, and results calculation. Auto titrators have many advantages over manual titrators, such as faster analysis, reproducible measurements, and more.

Learn more about the fully automatic titrator from Metrohm:

Go to OMNIS titrators

Learn more about automatic titration and the advantages over manual titration in our blog:

Blog: Save money by using automated titration systems

Blog: Why consider automation – even for simple titrations

Titration is one of the oldest analytical techniques and is usually performed manually. However, manual titration presents many challenges. An autotitrator automates the titration process, delivering faster, more accurate, and safer results compared to manual titration. The video summarizes the 5 top reasons to switch from manual to automated titration.

Easier preparation of the buret: An autotitrator fills the buret automatically.
Step-by-step guidance: An autotitrator automatically transfers the sample size from the balance to the software or instrument, adjusts the stirring speed, and more.
More reliable and reproducible endpoint evaluation: Automatic titrators ensure objective endpoint detection.
Complete documentation according to GxP: Autotitrators ensure compliance with FDA CFR Part 11 and EudraLex Vol. 4, Annex 11.
Safer handling of chemicals: Autotitrators reduce the exposure to hazardous chemicals.

In summary, the main benefits of an autotitrator are:

Speed and throughput: Faster analysis and higher sample throughput
Accuracy and reproducibility: Automated dosing and endpoint detection minimize human error
Efficiency: Frees lab personnel from repetitive tasks
Safety: Minimizes chemical exposure
Data management: Digital reports and integration with LIMS/ERP systems
Scalability: Modular accessories and automation options adapt to changing workloads

Learn more about autotitrators:

White Paper: Manual vs. Automated Titration: Benefits and Advantages to Switching

Webinar: The benefits of automating your titration applications

Blog: Why consider automation – even for simple titrations

Blog: How to transfer manual titration to autotitration

Choosing the right titrator depends on your sample type, analytical goals, and lab environment. Here are the key factors to consider:

Factors	Tips
Type of titration	Potentiometric titration: Ideal for acid-base, redox, complexometric, and precipitation reactions. Photometric: Suitable for colored, opaque, or non-aqueous samples. Thermometric titration: Best for samples where traditional sensors may not work. Conductometric titration: Useful for reactions involving ionic changes.
Sample characteristics	Consider whether your samples are liquids, solids, slurries, or gases. Some titrators offer accessories like homogenizers or sample preparation modules to handle complex matrices.
Throughput & automation	For high sample volumes, look for titrators with autosamplers or robotic automation (e.g., Metrohm’s OMNIS Sample Robot). Parallel titration capabilities can significantly boost lab efficiency.
Accuracy & reliability	Choose systems with precise dosing, sensitive sensors, and robust endpoint detection. Look for instruments that support method validation and reproducibility.
Compliance & data management	Ensure compatibility with GLP/GMP, 21 CFR Part 11, and other regulatory standards. Check for integration with LIMS, ERP, or ELN systems for traceability and audit readiness.
Modularity & scalability	Opt for a platform that grows with your lab. Metrohm’s OMNIS titrators allow expansion with additional modules and titration modes.
Support & service	Consider availability of training, application support, and service contracts. Ask about software updates, warranty coverage, and repair turnaround times.

Our titration experts are happy to assist you with your questions:

Contact us

The most common indication methods for automated titrations are potentiometric and photometric endpoint (EP) determination.

In potentiometric EP determination, the difference in potential is measured: The concentration-dependent potential of a solution is measured using an indicator electrode against a reference potential, which is measured using a reference electrode. Combined sensors including both indicator and reference electrode are also available.

In photometric EP determination, a photometric sensor, such as the Optrode from Metrohm, is used to determine the change in intensity at a particular wavelength of a light beam passing through a solution.

Another kind of titration that is less well known is thermometric titration. Thermometric EP determination relies on detecting temperature changes during the titration reaction. A highly sensitive temperature sensor monitors the solution, and the endpoint is identified by a sudden change in temperature, which occurs due to the exothermic or endothermic nature of the reaction. This method is especially useful for titrations where no suitable electrode or photometric indicator is available.

Learn more about potentiometric, photometric, and thermometric endpoint determination in our blog:

Blog: Recognition of endpoints (EP)

Blog: Thermometric titration – the missing piece of the puzzle

Webinar: Thermometric titration

OMNIS Automation, Rack, Sample robot, robot, Titration, OMNIS, Automation, lid, Omnis Sample Robot, roboter

Fully automated titration systems increase efficiency, accuracy, safety, and reliability of your titrations. Automated systems are ideal for high-throughput labs, routine analysis, and when minimizing manual labor is critical.

The OMNIS Sample Robot from Metrohm, for instance, allows you to fully automate the analysis of up to 175 samples.

Learn more about automated titration:

Webinar: The benefits of automating your titration applications

High-throughput labs not only need instruments with a large sample capacity, they also look for a system which offers flexibility and modularity to adapt to changing applications or peaks in workload.

OMNIS titrators and the OMNIS Sample Robot form the perfect titration system for high-throughput laboratories. OMNIS offers parallel titration, modular expansion, and automated sample handling. Watch the video to learn more.

Yes, entry-level Metrohm titrators (i.e., Eco Titrators) deliver reliable accuracy when paired with proper electrodes and validated methods.

The accuracy of titrations does not only depend on the instrument, it is the sum of several factors that contribute to it:

Choice of a suitable electrode or indication method
Choice of a suitable cylinder volume
Choice of a suitable titration mode
Accuracy of sample size (weighing/pipetting)
Homogenization of the sample
Electrode cleaning and maintenance
Burette maintenance
Other factors, depending on the specific titration method

An overview on how to get correct and accurate titration results can be found here:

Blog: How to avoid titration errors in your lab

Blog: Validation of titration methods

Webinar: Avoid titration mistakes through best practice sensor handling

Webinar: Troubleshooting titration: essential know-how for quality results

Validating a titration method ensures that the procedure delivers accurate, reproducible, and reliable results – especially when transitioning from manual to automated titration. Metrohm recommends following the validation framework outlined in USP General Chapter <1225> Validation of Compendial Procedures and ICH Guidance Q2(R1) Validation of Analytical Procedures: Text and Methodology, which includes the following key steps:

Perform standardization of the titrant using a primary standard or a pre-standardized solution
Assess the accuracy and precision of the titration results by performing reference measurements
Verify the linearity of your results, i.e., that the titration results are proportional to the analyte concentration across the expected range
Demonstrate specificity, i.e., that the method can accurately measure the analyte without interference from impurities, excipients, or degradation products.

Find more information:

Blog: Validation of titration methods

White paper: Recommendations for titration methods validation

Modern titration systems offer various data formats for transferring titration data to an external software (LIMS / ERP / ELN). The most common formats are:

PC/LIMS report
XML report
PDF
CSV

Any Metrohm titrator offers at least one of these options, either by transferring the corresponding data in a corresponding file to a USB memory stick or directly to a computer/network directory.

The OMNIS Software offers a convenient and secure data exchange between OMNIS and any 3^rd party software (e.g., LIMS, ERP, ELN) by direct transfer based on the REST software architecture.

Do you want to learn more about titration?

The free monograph "Practical titration" covers the theory of titration explaining titration reactions, indication methods, electrodes, and titrants. In the practical part, acid-base, precipitation, redox, complexometric, and chelometric titrations are discussed.