Determination of Nitrosamine Impurities

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Determination of Nitrosamine Impurities Using the Agilent 6475 Triple Quadrupole LC/MS System

Nitrosamine impurities are by-products that are produced in trace amounts during the manufacturing process of pharmaceutical drugs. These impurities are classified as potentially genotoxic impurities and probable carcinogens with long-term intake. Therefore, it is important to determine their levels in final drug products with a high level of sensitivity and confidence.

Agilent 6475 Triple Quadrupole LC/MS System

Nitrosamine Workflow Solution

Nitrosamine impurities are a focus for regulatory agencies. Nitrosamine impurities are by-products in the manufacturing process of pharmaceutical drugs. They are a member of the "cohort of concern," which classifies them as potentially genotoxic impurities and probable carcinogens with long-term intake.

The 6475 Triple Quadrupole combined with 1290 Infinity II LC is a robust LC/MS/MS system for routine analysis.

A comprehensive analysis of eight nitrosamine compounds was carried out on the 6475 LC/TQ coupled with the 1290 Infinity II Bio LC system and APCI source.

Analysis of Eight Nitrosamine Compounds using 6475 LC/TQ and 1290 Infinity II Bio LC/APCI System

A comprehensive analysis of eight nitrosamine compounds was carried out on the 6475 LC/TQ coupled with the 1290 Infinity II Bio LC system and APCI source.

It is demonstrated that the following compounds can be determined at low levels: 

  • N-Nitrosodimethylamine (NDMA)
  • N-Nitrosomorpholine (NMOR)
  • N-Nitrosomethylethylamine (NMEA)
  • N-Nitrosopyrrolidine (NPYR)
  • N-Nitrosodiethylamine (NDEA)
  • N-Nitrosopiperidine (NPIP)
  • N-Nitrosodi-n-propylamine (NDPA)
  • N-Nitrosodi-n-butylamine (NDBA)
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Application Note

Application Note for Pharma and Biopharma

  • 6475 Triple Quadrupole LC/MS with ESI, APCI, MMI and Jet Stream (AJS) high sensitivity ion source.
  • Routine monitoring and testing of Food, Pharma, Environmental & regulatory applications
  • Best-in-class sensitivity, precision, and scan speed
  • Screen, confirm, and quantify with triggered MRM (tMRM)
  • VacShield allows you to do front-end ion injector maintenance without breaking vacuum
  • Delivers reliable performance and high versatility for Analytical Labs
  • Fast screening workflow with Intelligent Reflex dramatically improves sample throughput
  • Regulatory compliance as defined by US FDA 21 CFR Part 11, EU Annex 11 and similar national electronic record regulations
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