Stability Testing

Stability Testing

Have confidence in the therapeutic efficacy of your drug substance and drug product with Waters stability testing solutions. Waters systems, columns, software, and technical support play a crucial role in the quality of your methods and speed of your analysis, delivering reliable and reproducible results with every run.

Have confidence in the therapeutic efficacy of your drug substance and drug product with Waters stability testing solutions. Waters systems, columns, software, and technical support play a crucial role in the quality of your methods and speed of your analysis, delivering reliable and reproducible results with every run.
Demonstrate reliability and batch-to-batch uniformity in quality control and release in drug manufacturing with Waters dissolution testing solutions.
Demonstrate reliability and batch-to-batch uniformity in quality control and release in drug manufacturing with Waters dissolution testing solutions.

Overview

Stability testing is essential in drug development to ensure that pharmaceutical products maintain their safety, efficacy, and quality throughout their shelf life. Forced degradation and mass balance studies help identify degradation pathways and quantify degradation products, ensuring a complete understanding of the drug’s stability profile and supporting the development of robust, stability-indicating analytical methods.​

Waters stability testing solutions help you achieve the highest accuracy and efficiency. Our reliable systems offer fast run times and advanced detection capabilities to quantify and characterize degradation products and low-level impurities. Waters columns deliver high efficiency separations and batch-to-batch reproducibility, making them ideal for complex analytical applications. LC-MS-certified vials minimize the formation of degradants, ensuring sample integrity. Our unmatched expert technical support services can help you develop and refine robust methods, making Waters your trusted partner in ensuring product quality and safety over time.​

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

Applications

Waters HPLC, UPLC, and MS technologies play a pivotal role in pharmaceutical stability studies by delivering precise separation, rapid analysis, and sensitive detection of degradation products. These tools enable comprehensive impurity profiling, support accurate mass balance, and facilitate the development of robust, stability-indicating methods—ensuring drug quality, safety, and regulatory compliance over time.

Waters HPLC, UPLC, and MS technologies play a pivotal role in pharmaceutical stability studies by delivering precise separation, rapid analysis, and sensitive detection of degradation products. These tools enable comprehensive impurity profiling, support accurate mass balance, and facilitate the development of robust, stability-indicating methods—ensuring drug quality, safety, and regulatory compliance over time.

Application Notes

Application Notes

Stability testing provides insight into the stability of a drug substance or drug product over time, and under the influence of environmental factors (e.g., temperature, humidity, and light) and in vivo factors (e.g., pH and liver microsomes). Developing robust and reproducible methods for this application can be challenging, time consuming, and complex. Learn how the right technologies and support can help you develop and validate robust methods in these application notes.

Stability testing provides insight into the stability of a drug substance or drug product over time, and under the influence of environmental factors (e.g., temperature, humidity, and light) and in vivo factors (e.g., pH and liver microsomes). Developing robust and reproducible methods for this application can be challenging, time consuming, and complex. Learn how the right technologies and support can help you develop and validate robust methods in these application notes.

Application Notes

Application Notes

Compound isolation in stability studies is vital for identifying and characterizing degradation products. Waters preparative solutions enable efficient isolation and purification of these compounds with high recovery and purity. These scalable, high-resolution systems support method development and regulatory compliance, ensuring accurate impurity profiling and deeper insight into drug stability.

Compound isolation in stability studies is vital for identifying and characterizing degradation products. Waters preparative solutions enable efficient isolation and purification of these compounds with high recovery and purity. These scalable, high-resolution systems support method development and regulatory compliance, ensuring accurate impurity profiling and deeper insight into drug stability.

Application Notes

Application Notes

Waters accurate mass LC-MS solutions, combined with UNIFI software, streamline the characterization of degradation products in stability studies. The systems capture full-scan and fragmentation data in a single run, while UNIFI automates structural elucidation. This workflow delivers rapid, confident identification of degradation pathways, even for non-expert users. Learn how Waters solutions can help streamline your stability testing in these application notes.​

Waters accurate mass LC-MS solutions, combined with UNIFI software, streamline the characterization of degradation products in stability studies. The systems capture full-scan and fragmentation data in a single run, while UNIFI automates structural elucidation. This workflow delivers rapid, confident identification of degradation pathways, even for non-expert users. Learn how Waters solutions can help streamline your stability testing in these application notes.​

Application Notes

Application Notes

Waters triple detection approach—combining UV, ELSD, and MS—offers a comprehensive solution for mass balance studies. Combined with the Waters selection of high-efficiency columns, this enables accurate quantification of all components, including non-UV-absorbing impurities, and supports robust method development. Integrated software tools streamline data analysis, ensuring precise impurity profiling and reliable stability assessments in pharmaceutical degradation studies.

Waters triple detection approach—combining UV, ELSD, and MS—offers a comprehensive solution for mass balance studies. Combined with the Waters selection of high-efficiency columns, this enables accurate quantification of all components, including non-UV-absorbing impurities, and supports robust method development. Integrated software tools streamline data analysis, ensuring precise impurity profiling and reliable stability assessments in pharmaceutical degradation studies.

Application Notes

Application Notes

Case Study: Improving Quality Control and Stability Testing Efficiency with Standardized Chromatography Operations

In this case study, learn how NAPP Pharmaceuticals and its Cambridge, UK facility leveraged Empower CDS to make improvements in its pharmaceutical QC and stability laboratories, improving both critical reporting for management as well as sample throughput for product release.

In this case study, learn how NAPP Pharmaceuticals and its Cambridge, UK facility leveraged Empower CDS to make improvements in its pharmaceutical QC and stability laboratories, improving both critical reporting for management as well as sample throughput for product release.
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Hand holding blue capsule pack at medicine pill production line

Solutions

Waters systems offer reliable and reproducible results for stability testing to support quality and efficacy in drug products and substances.

Waters systems offer reliable and reproducible results for stability testing to support quality and efficacy in drug products and substances.

The next evolution in separation science is here

The next evolution in separation science is here
ACQUITY Premier System

Enhance your routine LC-MS analyses with the Waters ACQUITY Premier System and ACQUITY QDa II Mass Detector, a compact mass detector system that operates in Empower Chromatography Data System. Experience superior separation and mass confirmation while seamlessly integrating mass spectral data into your compliant Empower Chromatography Data System workflow. Gain greater confidence in compound detection and confirmation with improved performance and efficiency.

  • Stability Testing
  • Method Development
  • Mass Balance Studies

Improve your lab productivity, efficiency, and throughput

Improve your lab productivity, efficiency, and throughput
Waters UHPLC/UPLC Systems

Enhance the performance of virtually any liquid chromatography-mass spectrometry (LC-MS) experiment with any MS using Waters UHPLC/UPLC systems to support improvements in your separation resolution and reproducibility. Pair with ACQUITY UPLC/UHPLC columns for enhanced selectivity regardless of molecule type or matrix complexity.

  • Stability Testing
  • Method Development
  • Compound Isolation
  • Mass Balance Studies

Complex chromatography challenges, solved

Complex chromatography challenges, solved
ACQUITY UPLC I-Class PLUS System

Achieve highly efficient, rapid separations from industry-leading ultra-low dispersion and delay volume with the ACQUITY UPLC I-Class PLUS System for narrow, ultra-efficient peaks, enhancing the sensitivity of any mass spectrometer and simplifying the characterization of the most complex sample.

  • Stability Testing
  • Method Development
  • Structural Elucidation
  • Mass Balance Studies

Complete coverage for confident characterization

Complete coverage for confident characterization
Xevo G3 QTof

Maximize sample information for your analytes from detailed characterization to accurate quantitation with the Xevo G3 QTof, which enables complete confidence in your results, from challenging small molecules to complex biotherapeutics.

  • Structural Elucidation

Separate beyond question with the power of mass detection

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

Obtain the selectivity of mass detection in a compact design with the ACQUITY QDa II Mass Detector. Its selected ion recording (SIR) acquisition reduces the impact of co-eluting matrix components, leading to simpler chromatograms, lower detection limits, and greater method flexibility.

  • Stability Testing
  • Method Development
  • Mass Balance Studies

Delivering SmartMS to the masses

Delivering SmartMS to the masses
ACQUITY RDa Detector

Increase productivity, improve data confidence, and simplify routine accurate mass workflows with the compact and easy-to-use ACQUITY RDa Detector.

  • Stability Testing
  • Method Development
  • Structural Elucidation

Simple, robust, and versatile mass detection

Simple, robust, and versatile mass detection
SQ Detector 2

Achieve uncompromised analysis across a wide mass range, from low to high molecular weight species, with the SQ Detector 2. Gain the chromatographic flexibility you need for reproducible results, along with seamless compatibility across all your applications.

  • Stability Testing
  • Method Development
  • Mass Balance Studies

Bring your analytical purification performance to the next level

Bring your analytical purification performance to the next level
Analytical Scale Purification System

Obtain a fully automated purification solution designed for purification labs that need more efficient purification on smaller prep scales with Waters Analytical Scale Purification System that offers high-capacity sample processing, fraction collection, and high-pressure capabilities.

  • Compound Isolation

Uniquely designed to accurately collect fractions from high-efficiency UPLC separations

Uniquely designed to accurately collect fractions from high-efficiency UPLC separations
Waters Fraction Manager - Analytical

Minimize fraction loss and carryover to better manage low volume peaks and efficiently collect small amounts of material for further assays with the Waters Fraction Manager (WFM-A), an analytical-scale fraction collector for UPLC systems.

  • Compound Isolation

Ensure your laboratory runs efficiently with Waters advanced software for stability testing.

Ensure your laboratory runs efficiently with Waters advanced software for stability testing.

Take control of your stability testing and increase workflow efficiency

Take control of your stability testing and increase workflow efficiency
NuGenesis Stability

Integrated into your NuGenesis LMS, the NuGenesis Stability module allows your lab to gain workflow efficiency across research and manufacturing environments, enforce a consistent, compliant, and standardized stability operation, and minimize the risk of human error – all without a LIMS.

  • Stability Testing

Simplify data acquisition, processing, and reporting

Simplify data acquisition, processing, and reporting
Empower Chromatography Data System (CDS)

Equip your lab with Empower Chromatography Data System (CDS) and gain advanced laboratory data management for your analyses, including acquisition, processing, and reporting for liquid and gas chromatography instruments.

  • Stability Testing
  • Method Development

Reduce complexity and increase speed to results

Reduce complexity and increase speed to results
waters_connect for Small Molecule Workflows

Maximize productivity with compliant-ready solutions for the analysis of compounds like pesticides, drugs of abuse, metabolites, impurities, extractables, and leachables with waters_connect for Small Molecule Workflows, using workflows through the UNIFI application.

  • Stability Testing
  • Method Development
  • Compound Isolation
  • Structural Elucidation
  • Mass Balance Studies

Streamline LC method development

Streamline LC method development
Fusion Method Development (FMD) Software from S-Matrix

Streamline LC method development by automating this process with Fusion Method Development (FMD) Software from S-Matrix. Fusion FMD works seamlessly with Empower 3 Chromatography Data Software (CDS) and ACQUITY Ultra Performance LC (UPLC) to automate liquid chromatographic method development according to Quality-by-Design guidelines.

  • Method Development

Quality and reliable consumables for stability testing in your laboratory.

Quality and reliable consumables for stability testing in your laboratory.

Reduce time wasted on column passivation and method optimization

Reduce time wasted on column passivation and method optimization
MaxPeak Premier Columns

See and do more with MaxPeak Premier Columns, which use progressive integrated technologies like MaxPeak High Performance Surfaces (HPS) to effectively reduce non-specific adsorption (NSA) losses due to metal interactions while increasing reproducibility, sensitivity, and overall results quality.

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  • Stability Testing
  • Method Development

Increase speed, sensitivity, and resolution, without compromising data integrity

Increase speed, sensitivity, and resolution, without compromising data integrity
ACQUITY UPLC Columns

Increase sample throughput, achieve unmatched resolution, improve analyte sensitivity, and meet all your method requirements and substantially reduce your analysis time and cost-per-sample with Waters ACQUITY UPLC Columns.

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  • Stability Testing
  • Method Development
  • Structural Elucidation

Particle stability and performance for methods development

Particle stability and performance for methods development
XBridge Columns

Waters XBridge HPLC and UHPLC Columns built to withstand high pH, high temperatures, and other extreme operating conditions like volatile eluents, for a wide range of small molecule and biomolecule LC-MS analysis.

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  • Stability Testing
  • Method Development
  • Mass Balance Studies
  • Structural Elucidation

Easily reduce risk and cost for LC-UV, LC-MS, and GC-MS analysis

Easily reduce risk and cost for LC-UV, LC-MS, and GC-MS analysis
Standard & Certified HPLC Sample Vials

Reduce risk for your LC-UV, LC-MS and GC-MS sample analysis with Waters suitable and certified reliable vials, plates, and certified containers – quality products that lead to quality results.

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  • Stability Testing
  • Structural Elucidation

The vial of choice for MS applications

The vial of choice for MS applications
TruView pH Control LCMS Certified Vials

Avoid analyte degradation of pH sensitive samples with Waters TruView pH Control LCMS Certified low adsorption vials.

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  • Stability Testing
  • Structural Elucidation

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

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

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. Maintain peak system performance, minimize downtime, address application challenges, and support stringent compliance requirements.

  • Stability Testing
  • Method Development
  • Compound Isolation
  • Structural Elucidation
  • Mass Balance Studies

Make science more accessible with Waters Capital

Make science more accessible with Waters Capital
Payment Solutions

Maximize your lab resources and minimize risk with payment options from Waters Capital, which includes innovative solutions to upgrade aging instruments, customized support, and flexible options to bundle your complete laboratory solution in one easy monthly payment – everything you need to advance your science.

  • Stability Testing
  • Method Development
  • Compound Isolation
  • Structural Elucidation
  • Mass Balance Studies

The data speaks for itself

The data speaks for itself
The full scan with fragmentation function of the ACQUITY RDa Detector
The full scan with fragmentation function of the ACQUITY RDa Detector is used to compare low and high energy channels in the analysis of glipizide Impurity III. Also shown in this UNIFI window, are the UV trace at 254 nm, and XIC’s for the API, impurity II and impurity III.
Preparative scale separation, on the Waters Analytical Scale Purification System
Preparative scale separation, on the Waters Analytical Scale Purification System, of a ranitidine drug sample forced degraded with base (A) and UV-triggered fraction collection (B).​
Improvement in Chromatographic Performance
Improvement in Chromatographic Performance for Stability Indicating Methods of Antiviral Drugs with MaxPeak Premier Technology.

Webinars and Resources

  • Brochure

NuGenesis Stability Protocol Management & Testing Solutions

NuGenesis Stability Protocol Management & Testing Solutions
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  • Brochure

NuGenesis Laboratory Management System Solution for Stability Management

NuGenesis Laboratory Management System Solution for Stability Management
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  • Brochure

Xevo G3 QTof Product Brochure

Xevo G3 QTof Product Brochure
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  • Brochure

The ACQUITY RDa Detector: Delivering SmartMS to the Masses

The ACQUITY RDa Detector: Delivering SmartMS to the Masses
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Related

Small Molecule Therapies
Whether your lab is focused on small molecule discovery, process development or quality control, Waters has the small molecule analysis solutions to meet your pharmaceutical lab requirements.

Method Development
Optimize your liquid chromatography and mass spectrometry method performance and minimize the variability of your data to generate a consistent reportable result with Waters diverse solutions for method development.

Preparative Chromatography Solutions
Simplify your sample purification with Waters preparative chromatography solutions, including preparative HPLC systems, columns and the lab equipment required to scale up.

Related

Learn more about Stability Testing Solutions.

Learn more about Stability Testing Solutions.
Demonstrate reliability and batch-to-batch uniformity in quality control and release in drug manufacturing with Waters dissolution testing solutions.
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