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.  

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


ACQUITY QDa II Mass Detector with ACQUITY Premier System in laboratory.

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


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. 


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

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

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

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

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

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


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 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 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 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 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
  • 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
  • Case Study

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

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


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