Start with the right column chemistry

The ACQUITY HSS T3 and XSelect HSS T3 Chemistry (available in 1.8 um, 3.5 um and 5 um particle sizes) provide excellent retention and separation of polar compounds making it the “go-to” column for the separation of nitrosamine impurities. The HSS T3 Chemistries unique combination of bonding and endcapping enhances column performance, lifetime, peak shape, loading capacity, method development, selectivity and stability.

Image: Chromatographic separation of nitrosamines impurities and drug substances on XSelect HSS T3 column and mass analysis window from Empower 3 Software for peak identity confirmation.

To reach the lowest detection limits you need instruments that afford the highest sensitivity:

for High Sensitivity Quantification

Xevo TQ-XS Triple Quadrupole Mass Spectrometer - Maintaining the highest levels of vigilance in the prevention of GTIs, requires instrumentation that allows you to detect what’s often undetectable. The Xevo TQ-XS Triple Quadrupole Mass Spectrometer delivers the highest sensitivity for trace analysis.

Atmospheric Pressure Chemical Ionization (APCI) - The IonSABRE APCI Probe affords high resolution and sensitivity using industry-leading ultra-low dispersion and delay volume.  

ACQUITY UPLC I-Class Plus System - Ultra-low dispersion (band spread to 4 µL), delay volumes, and efficient and narrow peaks of the ACQUITY UPLC I-Class PLUS System enhances the sensitivity of any mass spectrometer.

MassLynx Security - MassLynx Security with TargetLynx is the compliant-ready quantification mass spectrometry software that enable these high-sensitivity capabilities in a regulated environment. 

for Routine Testing

HPLC-UV meets the routine requirements to identify nitrosamine peaks.

ACQUITY Arc UHPLC System - The ACQUITY Arc UHPLC System is a dual-flow system that can be used to reproduce existing methods, or switched to UHPLC analysis by changing the flow. ACQUITY Arc shortens analysis time, speeds existing methods, and improves efficiency of method development. It minimizes variability, delivers maximum data quality and reproducibility, data confidence and unmatched compliance-readiness.

ACQUITY QDa Mass Detector - Adding the ACQUITY QDa Mass Detector allows for additional mass information on an unknown impurity. It provides critical mass data allowing you to identify and track analytes hidden in coelutions.

2998 Photodiode Array (PDA) Detector - The 2998 Photodiode Array (PDA) Detector offers advanced optical detection, wide linear dynamic range, and unique lamp optimization for trace impurity detection and quantification in conjunction with Peak Purity spectral analysis capabilities to identify coeluting impurities. 

Empower 3 Chromatography Data Management - Empower 3 and the Empower Method Validation Manager provide several advantages to support the analysis, monitoring, and control of potentially mutagenic impurities:

• Satisfies compliance requirements easily while improving data traceability
• Automates, streamlines, and simplifies method validation workflows
• Determines if data adheres to method validation requirements