Method Development

Method Development

Support the development of safe and effective medicines by minimizing method variability and generating consistent reportable results with Waters diverse portfolio of products and services. With Waters, you can implement systematic or multivariate experimental approaches and quality-by-design principles to meet ICH Q14 and USP <1220> regulatory requirements and elevate quality throughout the analytical procedure lifecycle.  

Support the development of safe and effective medicines by minimizing method variability and generating consistent reportable results with Waters diverse portfolio of products and services. With Waters, you can implement systematic or multivariate experimental approaches and quality-by-design principles to meet ICH Q14 and USP <1220> regulatory requirements and elevate quality throughout the analytical procedure lifecycle.  
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ACQUITY QDa II Detector with ACQUITY Premier System in lab | Scientist on computer
ACQUITY QDa II Detector with ACQUITY Premier System in lab | Scientist on computer

Overview

The development of new LC and LC-MS methods can be challenging and extremely time consuming. Waters is committed to providing products and services, as well as workflow and regulatory expertise, to help you optimize your method performance and improve efficiency and quality throughout the lifetime of use of your methods, with fit-for-purpose instrumentation, software, consumables, and support.

We can help you:

  • Adopt quality-by-design principles to manage the potential risks at each phase of your method’s journey

  • Implement systematic or multivariate experimental approaches, standardized workflows, and effective data management strategies

  • Modernize your approach with Waters Professional Services support

Applications

With enhanced approaches to procedural development, the focus transitions from the analytical method to the reportable result. Learn how modern-day approaches using Analytical Quality-by-design (AQbD) principles help you understand how sampling, storage, sample preparation, analytical procedure, instrument parameters, and data handling affect the variability of the reportable value, identifying, and minimizing areas of the procedure that could potentially introduce variability into your final result.

With enhanced approaches to procedural development, the focus transitions from the analytical method to the reportable result. Learn how modern-day approaches using Analytical Quality-by-design (AQbD) principles help you understand how sampling, storage, sample preparation, analytical procedure, instrument parameters, and data handling affect the variability of the reportable value, identifying, and minimizing areas of the procedure that could potentially introduce variability into your final result.

Application Notes

Application Notes

Many labs perform method development by evaluating one factor at a time. This approach can be time-consuming and fail to provide a robust method because of the limited experimental space explored. An alternative option is to adopt a systematic approach to method development, consisting of a pre-defined experimental set-up and ordered protocol. Through this controlled process, knowledge can be gathered to ensure that the key parameters affecting selectivity and resolution of a separation are evaluated.

Many labs perform method development by evaluating one factor at a time. This approach can be time-consuming and fail to provide a robust method because of the limited experimental space explored. An alternative option is to adopt a systematic approach to method development, consisting of a pre-defined experimental set-up and ordered protocol. Through this controlled process, knowledge can be gathered to ensure that the key parameters affecting selectivity and resolution of a separation are evaluated.

Application Notes

Application Notes

Transferring validated analytical methods between laboratories and different LC systems can be challenging. Instruments can vary in terms of settings, system design and system volumes, so that transfer can be time consuming and prone to failure. Waters systems and software are designed to accept and successfully replicate existing LC methods from a variety of platforms, producing equivalent test results, helping to keep your implementation of new methods on track.

Transferring validated analytical methods between laboratories and different LC systems can be challenging. Instruments can vary in terms of settings, system design and system volumes, so that transfer can be time consuming and prone to failure. Waters systems and software are designed to accept and successfully replicate existing LC methods from a variety of platforms, producing equivalent test results, helping to keep your implementation of new methods on track.

Application Notes

Application Notes

Tracking peaks across different chromatograms in the method development process can be difficult as sample components could shift, switch retention times, or even coelute under different separation conditions. A powerful, yet simple approach to addressing the challenge of shifting peaks is to combine a mass detector, such as the ACQUITY QDa II or SQ Detector 2, with optical detection in the method development process and use complimentary mass information to track peaks across different chromatograms.

Tracking peaks across different chromatograms in the method development process can be difficult as sample components could shift, switch retention times, or even coelute under different separation conditions. A powerful, yet simple approach to addressing the challenge of shifting peaks is to combine a mass detector, such as the ACQUITY QDa II or SQ Detector 2, with optical detection in the method development process and use complimentary mass information to track peaks across different chromatograms.

Application Notes

Application Notes

Method validation establishes that the performance characteristics of the method meet its intended purpose and is part of the overall validation process that includes software validation, instrument qualification, and system suitability. Waters Empower Method Validation Manager (MVM) automates and streamlines method validation, reducing time and costs by up to 80%, enhancing compliance, improving data traceability, and eliminating manual steps.

Method validation establishes that the performance characteristics of the method meet its intended purpose and is part of the overall validation process that includes software validation, instrument qualification, and system suitability. Waters Empower Method Validation Manager (MVM) automates and streamlines method validation, reducing time and costs by up to 80%, enhancing compliance, improving data traceability, and eliminating manual steps.

Application Notes

Application Notes

Case Study: The Method Detectives: Building a New Business Model with Analytical Procedure (Method) Lifecycle Management

In this case study, Waters ACQUITY UPLC and ACQUITY QDa technology adoption contributes to the success of Chromicent’s business by providing more information faster and earlier in the method development process, while Waters Empower Chromatography Data System (CDS) contributes to data handling and data integrity. 

In this case study, Waters ACQUITY UPLC and ACQUITY QDa technology adoption contributes to the success of Chromicent’s business by providing more information faster and earlier in the method development process, while Waters Empower Chromatography Data System (CDS) contributes to data handling and data integrity. 
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MLCM Method Lifecycle Management

Solutions

Waters LC-MS systems minimize method variability and generate consistent reportable results for safe and effective medicines.

Waters LC-MS systems minimize method variability and generate consistent reportable results for safe and effective medicines.

The next evolution in separation science is here

The next evolution in separation science is here
ACQUITY Premier System

Reduce analytical uncertainty and maximize the repeatability, robustness and sensitivity of your LC and LC-MS applications with Waters ACQUITY Premier System that step-up chromatographic performance, risk control and lab efficiency, bringing confidence in your results.

  • Enhanced Approach
  • Systematic Screening Approach
  • Method Transfer
  • Peak Tracking
  • Method Validation

See clearly and consistently, with confidence

See clearly and consistently, with confidence
Arc Premier System

Confidently produce faster, reproducible, and accurate data with Waters Arc Premier System that reduces non-specific adsorption due to metal interaction and produces correct and robust results reliably and easily.

  • Enhanced Approach
  • Systematic Screening Approach
  • Method Transfer
  • Peak Tracking
  • Method Validation

The ease of reversed-phase meets the power of normal-phase

The ease of reversed-phase meets the power of normal-phase
ACQUITY UPC2 System

Address routine and complex separation challenges while delivering reliability, robustness, and sensitivity with the ACQUITY UPC2 System to precisely vary mobile phase strength, pressure, and temperature for better control over analyte retention.

  • Enhanced Approach
  • Systematic Screening Approach
  • Method Transfer
  • Peak Tracking
  • Method Validation

Separate beyond question with the power of mass detection

Separate beyond question with the power of mass detection
ACQUITY QDa II Mass Detector

Seamlessly integrate Waters ACQUITY QDa II Mass Detector into your method development workflow to maximize your sample information while complementing new and existing workflows at reduced time.

  • Enhanced Approach
  • Systematic Screening Approach
  • Method Transfer
  • Peak Tracking
  • Method Validation

Simple, robust, and versatile mass detection

Simple, robust, and versatile mass detection
SQ Detector 2

Achieve uncompromised analysis of both low and high molecular weight species with a wide mass range with the SQ Detector 2 for reproducible results and versatile chromatographic options to ensure compatibility with all of your applications.

  • Enhanced Approach
  • Systematic Screening Approach
  • Method Transfer
  • Peak Tracking
  • Method Validation

Waters software streamlines data acquisition, processing, and reporting of consistent results to develop safe and effective medicines.

Waters software streamlines data acquisition, processing, and reporting of consistent results to develop safe and effective medicines.

Elevate your chromatography with the universal language of the lab

Elevate your chromatography with the universal language of the lab
Empower Chromatography Data System (CDS)

Simplify the way you collect, manage, and report chromatography test results with Empower Chromatography Data System (CDS) to address your most rigorous chromatographic, regulatory, and networking challenges, easily scalable from a single workstation to an enterprise-wide network.

  • Enhanced Approach
  • Systematic Screening Approach
  • Method Transfer
  • Peak Tracking
  • Method Validation

Automate the method validation workflow

Automate the method validation workflow
Empower Method Development Tools

Obtain a powerful workflow-based solution for automated chromatographic method validation, from protocol planning through final reporting with Empower Method Development Tools to manage validation from start to finish - using one comprehensive, automated tool.

  • Enhanced Approach
  • Systematic Screening Approach
  • Method Transfer
  • Peak Tracking
  • Method Validation

Automated, Quality-by-Design solution for rapid LC method development

Automated, Quality-by-Design solution for rapid LC method development
Fusion QbD® Method Development™ Software (S-Matrix® Corporation)

Automate LC method development with Fusion QbD® Method Development™ Software from S-Matrix® Corporation that integrates with Waters HPLC systems and Empower Chromatography Software to manage complex statistics, model method screening and optimization experiments, and integrate method robustness testing during method development and implementation for routine use.

  • Enhanced Approach
  • Systematic Screening Approach
  • Method Transfer
  • Peak Tracking
  • Method Validation

Our reliable and robust columns and consumables can be easily integrated into your chromatography workflows.

Our reliable and robust columns and consumables can be easily integrated into your chromatography workflows.

Stop looking and start seeing – no compromise required 

Stop looking and start seeing – no compromise required 
ACQUITY Premier Columns 

Achieve increases in sensitivity and analyte recovery while reducing column passivation time and mitigating unwanted analyte/surface interactions with ACQUITY Premier Columns that are built on Waters industry-leading sub-2-µm particle technologies.

  • Enhanced Approach
  • Systematic Screening Approach
  • Method Transfer
  • Peak Tracking
  • Method Validation

Meet your analytical challenges with the right vial

Meet your analytical challenges with the right vial
Vials

Reduce failed assays from unknown contaminant peaks with Waters sample vials, held to the tightest dimensional tolerances and manufactured via a 2-, 3-, or 4-step certification process to meet and maintain specified vial dimensions, levels of cleanliness, and adsorption properties from batch to batch. 

  • Enhanced Approach
  • Systematic Screening Approach
  • Method Transfer
  • Peak Tracking
  • Method Validation

Achieve testing efficiencies and accurate results using streamlined Waters services and support.

Achieve testing efficiencies and accurate results using streamlined Waters services and support.

Reduce the burden of updating your aging HPLC systems

Reduce the burden of updating your aging HPLC systems
FlexMETHODS Method Migration Service for Validated LC Methods

Ensure safe migration and upgrading of your trusted methods to new HPLC technology with Waters FlexMETHODS Method Migration Service* that keeps your laboratory up to date.

Not available for sale in all countries.
For information on availability, please contact your local representative.
  • Enhanced Approach
  • Systematic Screening Approach
  • Method Transfer
  • Peak Tracking
  • Method Validation

Refresh outdated lab instruments and software

Refresh outdated lab instruments and software
FlexUP Technology Trade-In Program

Cost-effectively refresh your aging instruments from Waters or another manufacturer with Waters FlexUP Technology Trade-In Program so your lab can work with the latest technology for optimum productivity and security.

Not available for sale in all countries.
For information on availability, please contact your local representative.
  • Enhanced Approach
  • Systematic Screening Approach
  • Method Transfer
  • Peak Tracking
  • Method Validation

Your success is just a click away

Your success is just a click away
Waters Global Services

Optimize your laboratory's productivity and success with Waters Global Services to maintain peak system performance, minimize downtime, address application challenges, and support stringent compliance requirements.

  • Enhanced Approach
  • Systematic Screening Approach
  • Method Transfer
  • Peak Tracking
  • Method Validation

The data speaks for itself

The data speaks for itself
Spectral peak purity verification using UV and MS spectral data. Analysis of the ophthalmic solution. Chromatographic separation with peak table data (A). UV peak purity plot of naphazoline impurity A (B) and Empower 3 Mass Analysis window with peak purity spectrum (C).
The Empower custom scoring report uses custom calculations and reporting, designed to facilitate selection of the conditions by identifying the total number of peaks that have met the separation goals.
Representative chromatograms from the 12 DOE runs. A: represents three experiments that were performed on a Standard ACQUITY Arc System under different scouting conditions and B represents three experiments that were performed on the Arc Premier System under the same conditions. Conditions in common between all chromatograms are: Mobile phase A: 10 mM Ammonium formate in water, flow rate 0.50 mL/min, temperature 30 °C, 0.0–15 min, and 10–90% B linear gradient. Variations in conditions are detailed in the figure.
Method development for pH scouting. Representative chromatograms (A) and MS Peak Tracking report (B) for low and high pH experiments.

Webinars and Resources

  • White Paper

A Complete Solution to Perform a Systematic Screening Protocol for LC Method Development

A Complete Solution to Perform a Systematic Screening Protocol for LC Method Development
Download
  • Case Study

Streamlining Method Validation in Pharmaceutical Product Development with Empower Chromatography Data System

Streamlining Method Validation in Pharmaceutical Product Development with Empower Chromatography Data System
Download
  • Case Study

Analytical Procedure (Method) Lifecycle Management Drives Method Development at Innovative CDMO

Analytical Procedure (Method) Lifecycle Management Drives Method Development at Innovative CDMO
Download
  • White Paper

Control Method-Related Data Quality Risks During Chromatographic Analysis with Fit-for-Purpose, High Quality Vials

Control Method-Related Data Quality Risks During Chromatographic Analysis with Fit-for-Purpose, High Quality Vials
Download

Learn more about Method Development Solutions.

Learn more about Method Development Solutions.
ACQUITY QDa II Detector with ACQUITY Premier System in lab | Scientist on computer
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