The Shimadzu triple-quad GCMS-TQ8040 NX features smart technologies to boost the efficiency of routine analytical work. It automatically determines all optimum transitions and collision energies, seamlessly incorporating them into the Smart Database Series.
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
GCMS-TQ8050 NX, HS-20
- 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
Quantitation of 5 Nitrosamines in Metformin API and Formulation by HS-GCMS/MS
GCMS-TQ8040 NX, HS-20
- 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
Detection and Quantitation of Nitrosamine Impurities in Drug Substances by LC-HRMS on LCMS-9030
- 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.
The Shimadzu triple-quad GCMS-TQ8050 NX is capable of performing unprecedented quantitative GC-MS/MS analyses of ultra-trace amounts, down to the femtogram level.
The LCMS-9030 quadrupole time-of-flight (Q-TOF) mass spectrometer is a powerful instrument that integrates the world's fastest and most sensitive quadrupole technology with TOF capabilities for accurate mass measurement.