Impurity Analysis

Impurity Analysis

Identify, quantify, and routinely monitor the presence of unwanted impurities in pharmaceutical medicines  with the sensitivity and specificity needed to support increasingly stringent regulatory driven controls protecting patient safety. Waters is dedicated to supporting impurity control across late-stage drug development, to formulation and product release providing robust and reliable high-performance chemistry, LC, and and MS analytical technologies to support consistent control of all impurities, assuring product quality.

Identify, quantify, and routinely monitor the presence of unwanted impurities in pharmaceutical medicines  with the sensitivity and specificity needed to support increasingly stringent regulatory driven controls protecting patient safety. Waters is dedicated to supporting impurity control across late-stage drug development, to formulation and product release providing robust and reliable high-performance chemistry, LC, and and MS analytical technologies to support consistent control of all impurities, assuring product quality.
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Female holding various pills on hand
Female holding various pills on hand

Overview

Global regulatory bodies require pharmaceutical manufacturers, and contract organizations or service providers to control the presence of known and unknown impurities in drug substance and final pharmaceutical drug products. Laboratories must have the capability to identify and quantify impurities and adopt onward control strategies for them with suitable analytical techniques. This facilitates meeting regulatory requirements that protect the quality, safety and onwards supply chain of released products. ​

Characterizing, quantifying and monitoring pharmaceutical impurities can be challenging due to the diverse chemical nature of the analytes, complexity of sample matrices, and often extremely low or trace level detection levels necessary. Waters diverse impurity analysis solutions, including chemistry and consumables, LC and MS technologies, and enabling compliant-ready software, ensure the accurate detection and identification of unknown impurities and their routine, robust, and sensitive quantification to beyond the regulatory required levels and within the expectations of a compliant laboratory environment.​

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Explore N-Nitrosamines Analysis

Controlling potentially mutagenic N-Nitrosamine impurities in pharmaceuticals is essential for meeting global safety standards for medicines. Discover how Waters supports the pharmaceutical industry in managing N-Nitrosamine control with comprehensive analytical solutions for risk assessment, testing, and ongoing batch monitoring.

Controlling potentially mutagenic N-Nitrosamine impurities in pharmaceuticals is essential for meeting global safety standards for medicines. Discover how Waters supports the pharmaceutical industry in managing N-Nitrosamine control with comprehensive analytical solutions for risk assessment, testing, and ongoing batch monitoring.
Learn More
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Applications

Identify and characterize impurities from your pharmaceutical formulations with Waters chromatography workflows. Waters is committed to supporting the quality of your products and safety of your patients by helping you generate precise impurity profiles to support full compliance with regulatory requirements.

Identify and characterize impurities from your pharmaceutical formulations with Waters chromatography workflows. Waters is committed to supporting the quality of your products and safety of your patients by helping you generate precise impurity profiles to support full compliance with regulatory requirements.

Application Notes

Application Notes

Ensuring strict control measures are essential to meet regulatory guidelines related to the potential presence of mutagenic impurities in medicines, specifically nitrosamines. Waters provides accessible LC-MS and MS/MS solutions enabling the development of sensitive, accurate and robust analytical methodologies for the detection and quantification of all types of genotoxic impurities and their precursors.

Ensuring strict control measures are essential to meet regulatory guidelines related to the potential presence of mutagenic impurities in medicines, specifically nitrosamines. Waters provides accessible LC-MS and MS/MS solutions enabling the development of sensitive, accurate and robust analytical methodologies for the detection and quantification of all types of genotoxic impurities and their precursors.

Application Notes

Application Notes

Many quality control methods in use today are HPLC methods that share a common goal: to measure the concentration of any active ingredient and any known impurity and record the results in compliance with regulatory standards. Trustworthy HPLC test results are essential in helping ensure the uninterrupted supply of safe and effective medicines.

Many quality control methods in use today are HPLC methods that share a common goal: to measure the concentration of any active ingredient and any known impurity and record the results in compliance with regulatory standards. Trustworthy HPLC test results are essential in helping ensure the uninterrupted supply of safe and effective medicines.

Application Notes

Application Notes

Forced degradation involves the degradation of drug products and drug substances at more severe conditions in order to study API stability. With Waters solutions, your lab can identify drug stability, which impacts drug purity, potency, and safety.

Forced degradation involves the degradation of drug products and drug substances at more severe conditions in order to study API stability. With Waters solutions, your lab can identify drug stability, which impacts drug purity, potency, and safety.

Application Notes

Application Notes

Blog: Mutagenic Impurity Risk Assessment Throughout the Development and Manufacturing Process 

Impurity risk assessments are necessary for the clinical evaluation of drugs, but a systematic approach is necessary to conduct risk assessments safely and precisely. Learn a potential multi-disciplinary approach for mutagenic impurity risk assessment with this blog.

Impurity risk assessments are necessary for the clinical evaluation of drugs, but a systematic approach is necessary to conduct risk assessments safely and precisely. Learn a potential multi-disciplinary approach for mutagenic impurity risk assessment with this blog.
Read the Blog
Medical pills in a hand of laboratory worker

Solutions

With Waters systems, quantify nitrosamine impurities from pharmaceutical formulations and products in less time and with greater confidence.

With Waters systems, quantify nitrosamine impurities from pharmaceutical formulations and products in less time and with greater confidence.

The next evolution in separation science is here

The next evolution in separation science is here
ACQUITY Premier System

Maximize the sensitivity, repeatability, and robustness of your LC and LC-MS impurity quantitation applications with the ACQUITY Premier System, enabling you to minimize the risk of undetected analytes for increased confidence in your results.

  • Small Molecules
  • Impurities Analysis
  • Mutagenic and Genotoxic Impurity Analysis
  • Routine Testing on HPLC
  • Forced Degradation

Absolute power to easily quantitate your most challenging compounds

Absolute power to easily quantitate your most challenging compounds
Xevo TQ Absolute

Achieve absolute confidence to reach lower limits of quantitation even for challenging impurities with the Xevo TQ Absolute, a powerful system that delivers absolute performance for complete results.

  • Small Molecules
  • Impurities Analysis
  • Mutagenic and Genotoxic Impurity Analysis
  • Forced Degradation

Complex chromatography challenges, solved

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

Improve your resolving power, lower your system volume, and achieve the tallest, sharpest peaks for your impurity analyses with the ACQUITY UPLC I-Class PLUS System.

  • Small Molecules
  • Impurities Analysis
  • Mutagenic and Genotoxic Impurity Analysis
  • Routine Testing on HPLC
  • Forced Degradation

Complete coverage for confident characterization to quantitation

Complete coverage for confident characterization to quantitation

Xevo G3 QTof

Maximize pharmaceutical sample information for your analytes from detailed characterization to accurate quantitation with the Xevo G3 QTof, a high-performance benchtop system that delivers accurate qualitative and quantitative sample information in small or large amounts.

  • Small Molecules
  • Impurities Analysis
  • Impurity Characterization
  • Mutagenic and Genotoxic Impurity Analysis

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, compliant-ready and easy-to-use ACQUITY RDa Detector.

  • Small Molecules
  • Impurities Analysis
  • Impurity Characterization
  • Routine Testing on HPLC
  • Forced Degradation

Separate beyond question with the power of mass detection

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

Streamline impurity profiling with the ACQUITY QDa II Mass Detector. Traditional methods may fall short due to lack of specificity and sensitivity, mass detection provides fast, accurate, identification and quantitation of API-related impurities using compliant ready Empower Chromatography Data System software.

  • Small Molecules
  • Impurities Analysis
  • Impurity Characterization
  • Routine Testing on HPLC
  • Forced Degradation

Waters software streamlines data acquisition, processing, and reporting impurity analysis results.

Waters software streamlines data acquisition, processing, and reporting impurity analysis results.

Delivering connected science for your lab evolution

Delivering connected science for your lab evolution
waters_connect Software Solutions

Streamline workflows, improve usability and compliance, and accelerate scientific and business outcomes with waters_connect lab informatics software, a single platform for LC and LC-MS applications for quantitation, identification, and other accurate mass-based analyses.

  • Small Molecules
  • Impurities Analysis
  • Impurity Characterization
  • Mutagenic and Genotoxic Impurity Analysis
  • Routine Testing on HPLC
  • Forced Degradation

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 impurity analyses, including acquisition, processing, and reporting for liquid and gas chromatography instruments.

  • Small Molecules
  • Impurities Analysis
  • Impurity Characterization
  • Mutagenic and Genotoxic Impurity Analysis
  • Routine Testing on HPLC
  • Forced Degradation

Our full range of columns and consumables can be easily integrated into your chromatography and mass spec workflows.

Our full range of columns and consumables can be easily integrated into your chromatography and mass spec workflows.

Normal-phase alternative selectivity with reversed-phase ease and reliability

Normal-phase alternative selectivity with reversed-phase ease and reliability
ACQUITY HSS T3 Chemistry Columns

Promote polar compound retention and aqueous mobile-phase compatibility with ACQUITY HSS T3 Columns that are more effective than traditional trimethyl silane (TMS) end-capping to enhance column performance, method development, selectivity, and stability. 

  • Small Molecules
  • Impurities Analysis
  • Impurity Characterization
  • Mutagenic and Genotoxic Impurity Analysis
  • Routine Testing on HPLC
  • Forced Degradation

Achieve unmatched reproducibility with a wide range of selectivity 

Achieve unmatched reproducibility with a wide range of selectivity 
XSelect HSS T3 Chemistry Columns

Achieve reproducible and highly selective chromatographic separations with the XSelect Column family, that features High Strength Silica (HSS) T3 particle technology for excellent retention of polar analytes with high efficiency and low pH stability.

  • Small Molecules
  • Impurities Analysis
  • Impurity Characterization
  • Mutagenic and Genotoxic Impurity Analysis
  • Routine Testing on HPLC
  • Forced Degradation

Next-generation particle and surface technology for increased polar analyte retention  

Next-generation particle and surface technology for increased polar analyte retention  
Atlantis Premier Columns

Boost retention of polar acidic compounds by 50% while eliminating unwanted analyte-surface interactions using Atlantis BEH C18 AX Premier Columns, designed to achieve superior polar compound retention.

  • Small Molecules
  • Impurities Analysis
  • Impurity Characterization
  • Mutagenic and Genotoxic Impurity Analysis
  • Routine Testing on HPLC
  • Forced Degradation

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 while addressing your budget realities with Waters Global Services. Maintain peak system performance, minimize down time, address scientific application challenges, and support stringent compliance requirements.

  • Small Molecules
  • Impurities Analysis
  • Impurity Characterization
  • Mutagenic and Genotoxic Impurity Analysis
  • Routine Testing on HPLC
  • Forced Degradation

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.

  • Small Molecules
  • Impurities Analysis
  • Impurity Characterization
  • Mutagenic and Genotoxic Impurity Analysis
  • Routine Testing on HPLC
  • Forced Degradation

Refresh outdated lab instruments and software

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

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

  • Small Molecules
  • Impurities Analysis
  • Impurity Characterization
  • Mutagenic and Genotoxic Impurity Analysis
  • Routine Testing on HPLC
  • Forced Degradation

The data speaks for itself

The data speaks for itself
Method linearity with 1/x weighting acquired using the Xevo TQ Absolute Mass Spectrometer.
MRM chromatogram resulting from the analysis of an authentic standard mix of propranolol, N-formylpropranolol and N-nitroso-propranolol at 1 ng/mL, 10 µL inj. in methanol. A peak at the same tR of N-formylpropranolol is visible in the 289>145 MRM transition of N-Nitroso-propranolol.

3A. NDMA summary plot of calculated concentrations (mean accuracy) at QC level A (12.5 ng/mL spike) and B (1.25 ng/mL spike), and calibration curve (0.1–100 ng/mL).

3B. NDEA summary plot of calculated concentrations (mean accuracy) at QC level A (12.5 ng/mL spike) and B (1.25 ng/mL spike), and calibration curve (0.025–25 ng/mL).
Use of a custom calculation displaying the relative intensity of glipizide and the impurities within a sample.

Webinars and Resources

  • Blog

Nitrosamine Impurities: The Need to Verify

Nitrosamine Impurities: The Need to Verify
Download
  • Brochure

Supporting the Challenge of Nitrosamine Drug Substance Related Impurities Analysis Brochure

Supporting the Challenge of Nitrosamine Drug Substance Related Impurities Analysis Brochure
Download
  • Case Study

Evaluating the Risk of Nitrosamine Contamination with the ACQUITY UPLC I-Class PLUS and the Xevo TQ-XS Tandem Quadrupole Mass Spectrometer

Evaluating the Risk of Nitrosamine Contamination with the ACQUITY UPLC I-Class PLUS and the Xevo TQ-XS Tandem Quadrupole Mass Spectrometer
Download
  • On Demand Webinar

Impurities Summer Series

Impurities Summer Series
Watch Video

Related

Nitrosamine Analysis
Enhance quality control and ensure patient safety by controlling the presence of N-nitrosamines in pharmaceuticals with Waters precise nitrosamine impurity analysis LC-MS/MS detection technologies.

Learn more about Impurity Analysis Solutions.

Learn more about Impurity Analysis Solutions.
Female holding various pills on hand
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