ndma-analysis

New and Improved Optima® LC/MS Solvents

Optima® LC/MS Solvents now lead the industry with an unprecedented LC-UV gradient suitability specification that was developed by using advanced UHPLC technology coupled with PDA detection optics. Contaminants screened at a wavelength between 200-400nm gives a clear visibility of the solvent quality and hence each batch of optima® LCMS solvents are screened in this range.

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FDA Approved Methods for Detection of NDMA

Liquid Chromatography-High Resolution Mass Spectrometry (LC-HRMS) Method for the Determination of NDMA in Ranitidine Drug Substance and Drug Product

Principle

N-Nitrosodimethylamine (NDMA) impurity is separated from ranitidine by reverse phase chromatography and is detected by a high-resolution and high-mass accuracy (HRAM) mass spectrometer. High sensitivity detection is achieved by monitoring the accurate m/z value of the protonated impurity ion. Quantitation is performed by comparing the peak area of the NOMA impurity in extracted ion chromatogram of the samples to the peak area of the NDMA reference standard in an external calibration standard.

Reagents

  • NDMA Reference Standard
  • Formic Acid, LC/MS Grade (Fisher A 117-50 or Equivalent)
  • Acetonitrile, LC/MS Grade (Fisher A955-4 or Equivalent)
  • Methanol, LC/MS Grade (Fisher A456-4 or Equivalent)
  • Water, LC/MS Grade or Equivalent


Liquid Chromatography-High Resolution Mass Spectrometry (LC-HRMS) Method for the Determination of Six Nitrosamine Impurities in ARB Drugs

Principle

The six nitrosamine impurities (NDMA, NDEA, NEIPA, NDIPA, NDBA, and NMBA) are separated from each other and from losartan by reverse phase chromatography and are detected by a high-resolution and high-mass accuracy (HRAM) mass spectrometer. A high sensitivity of detection is achieved by monitoring the accurate m/z values of the protonated or deprotonated impurity ions or their fragments. Quantitation of samples is evaluated by considering the peak area of the impurities extracted from ion chromatograms of samples against the standard from an external calibration containing reference standards for all these six impurities.

Reagents

  • Reference Standards for NDMA, NDEA, NEIPA, NDIPA, NDBA, and NMBA
  • Formic Acid, LC/MS Grade (Fisher A117-50 or Equivalent)
  • Methanol, LC/MS Grade (Fisher A456-4 or Equivalent)
  • Water, LC/MS Grade or Equivalent
  • 2-Propanol, LC Grade

 

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Learn more about Analysis of Nitrosamine Impurities in Ranitidine

Q Exactive™ Hybrid Quadrupole-Orbitrap™ Mass Spectrometer

Thermo Scientific™ Q Exactive™ Hybrid Quadrupole-Orbitrap Mass Spectrometer

Identify, quantify and confirm more compounds rapidly and with confidence using the Thermo Scientific™ Q Exactive™ Hybrid Quadrupole-Orbitrap Mass Spectrometer. This benchtop LC-MS/MS system combines quadruple precursor ion selection with high-resolution, accurate-mass (HRAM) Orbitrap detection to deliver exceptional performance and versatility. The Q Exactive Mass Spectrometer is equally useful for untargeted or targeted screening and a broad range of qualitative and quantitative applications in drug discovery, proteomics, environmental and food safety, clinical research and forensic toxicology.