Nitrosamines & NDSRIs Studies
Nitrosamines and NDSRIs (Nitrosamine Drug Substance-Related Impurities) are among the most closely regulated trace-level impurities in pharmaceuticals today. Regulatory expectations in this area continue to evolve rapidly, with US FDA, Health Canada, TGA (Australia) and EMA each maintaining their own current risk-categorisation frameworks and Acceptable Intake (AI) limits. DALPL's Pharma Testing Division develops and validates ultra-trace analytical methods to detect and quantify nitrosamines and NDSRIs against the current requirements of all four agencies, supporting drug substance and drug product manufacturers through risk assessment, method development, validation and routine testing.
Testing Scope
DALPL provides highly specific trace-level nitrosamine and NDSRI analysis across diverse pharmaceutical matrices, supporting both drug substance and formulated drug product manufacturers.
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Active Pharmaceutical Ingredients (APIs) / Drug Substance Trace analysis and risk evaluation of drug substances.
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Drug ProductsTablets Capsules Injectables Ointments Lotions Syrups Suspensions Gels Inhalations Creams & Emulsions Transdermal Patches Other dosage forms
Our Nitrosamine & NDSRI Testing Services
High-resolution analytical workflows engineered to meet the stringent ng/day-level Acceptable Intake (AI) requirements of global regulatory agencies.
Method Development & Validation
Method development and validation targeted to each impurity's current, agency-specific AI limit — achieving the stringent limits of quantification (LOQ) these ng/day-level limits require.
Routine & Stability Testing
Routine and stability-program testing of drug substances and drug products for confirmed and predicted nitrosamine/NDSRI risk across the product lifecycle.
Analytical Capabilities
Our laboratory is equipped with state-of-the-art mass spectrometry platforms capable of achieving the ultra-trace quantification limits required for nitrosamines and NDSRIs.
LC-MS/MS
AB SCIEX QTRAP 5500 and Triple Quad 5500 systems coupled with Agilent and Shimadzu UPLC.
GC-MS/MS
Agilent 7010B equipped with Flame Ionization Detection (FID) and headspace capabilities.
HS-GC-MS/MS
Dedicated Headspace GC-MS/MS configurations for highly sensitive volatile nitrosamine analysis.
Why DALPL
Delivering high-accuracy impurity profiling with uncompromised regulatory integrity.
How It Works
A streamlined, audit-ready scientific pathway from initial requirement assessment to comprehensive regulatory reporting.
Analytical Approach / Method Development
Develop and validate targeted LC-MS/MS or GC-MS/MS methods designed to achieve the necessary ng/day-level LOQ.
Trace-Level Analysis
Execute routine or stability-program testing under strictly controlled, audit-ready laboratory conditions.
Results & Reporting
Deliver comprehensive analytical reports ready for regulatory submission to the FDA, EMA, TGA or Health Canada.
Explore Related Testing Services
Get Nitrosamine & NDSRI Testing Support
Speak with our pharmaceutical testing specialists to discuss your method development, validation, or batch release requirements.