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.

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.​


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.


White and blue pills in blister packs

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
Many multi-colored pills

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.


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

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

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

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

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

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

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


The data speaks for itself

The data speaks for itself
Method linearity with 1/x weighting acquired using the Xevo TQ Absolute Mass Spectrometer Method linearity with 1/x weighting acquired using the Xevo TQ Absolute Mass Spectrometer.
MRM chromatogram resulting from the analysis of an authentic standard 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.
NDMA summary plot of calculated concentrations

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 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
  • Brochure

Supporting the Challenge of Nitrosamine Drug Substance Related Impurities Analysis Brochure

Supporting the Challenge of Nitrosamine Drug Substance Related Impurities Analysis Brochure
  • 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
  • On Demand Webinar

Impurities Summer Series

Impurities Summer Series

Related

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