Solutions for Nitrosamine Analysis - GC-MS/MS and LC-HRMS Method-​

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Solutions for Nitrosamine Analysis - GC-MS/MS and LC-HRMS Method-​

 

The USFDA has extensively investigated the presence of nitrosamines (NSAs), a type of genotoxic impurity, in various drugs, and has recently expanded the list of identified nitrosamines for monitoring.​
Read more below to learn how Shimadzu can meet your nitrosamine analysis needs, from routine lot and batch testing to present and future drug discovery.

Trace Level Quantitation of 6 Nitrosamines in Metformin API by Dynamic Headspace GC-MS/MS

Trace Level Quantitation of 6 Nitrosamines in Metformin API by Dynamic Headspace GC-MS/MS

 

 

GCMS-TQ8050 NX, HS-20

User Benefits

  • Dynamic headspace equipped with GC-MS/MS was used for trace level quantitation of Nitrosamines in Metformin API
  • GCMS-TQ8050 NX system equipped with HS-20 easily meets the criteria as per the regulatory guidelines on Nitrosamines
  • Compared to static headspace, dynamic headspace has advantage in trace level detection of Nitrosamines

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Quantitation of 5 Nitrosamines in Metformin API and Formulation by HS-GCMS/MS

Quantitation of 5 Nitrosamines in Metformin API and Formulation by HS-GCMS/MS

 

GCMS-TQ8040 NX, HS-20​

User Benefits​

  • A HS-GCMS/MS method for the determination of 5 Nitrosamines in Metformin API & formulation
  • The GCMS-TQ8040 NX system easily meets the criteria as per the USFDA guidance on Nitrosamines

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Detection and Quantitation of Nitrosamine Impurities in Drug Substances by LC-HRMS on LCMS-9030

Detection and Quantitation of Nitrosamine Impurities in Drug Substances by LC-HRMS on LCMS-9030

 

 

LCMS-9030​

User Benefits​

  • Simultaneous analysis of up to eight N-nitrosamine impurities in drug substances by LC-HRMS method on LCMS-9030.
  • A targeted MS/MS (TOF) method with 2 m/z isolation window by the quadrupole was optimized to obtain best sensitivity.
  • A mass tolerance of (±)15 ppm was adopted to produce extracted-ion chromatograms (XICs) for quantitation.​

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