Nitrosamines creating alarm in our industry
Recent reports have identified well-known drug products containing unacceptable levels of nitrosamine impurities. Consequences of the contamination have included drug recalls, warning letters, and drug shortages, resulting in loss of both revenue and consumer confidence.
New regulations necessitate more rigorous controls
Whether your company has been directly impacted or not, new EMA and FDA regulations are requiring more stringent detection of these genotoxic impurities (GTIs) for products sold in their markets.
Can your technology easily detect the lowest impurity levels?
Minimize your risk of missing a nitrosamine, other GTI, or potentially mutagenic impurity (PMI) by using Waters' most sensitive LC-MS technology and application expertise.
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.
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:
Webinar: How to Avoid the Next Nitrosamine Crisis
Nitrosamine Impurities: The Need to Verify
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The Current Concerns About Genotoxic Impurities Found in Commonly Used Prescription and Over The Counter Pharmaceutical Drugs:
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Method Lifecycle Management: Keep Your Method Fit for Life.
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