Gaining control over nitrosamines starts with knowing what you are looking for.
Nitrosamine impurities in medicinal products are subject to increasingly strict requirements from regulators such as the EMA and FDA. Brightlabs combines scientific expertise with advanced mass spectrometry to detect both known nitrosamines and complex API-specific impurities at ultra-low concentrations.
Advanced mass spectrometry for reliable nitrosamine analysis.
Comprehensive nitrosamine analysis.
Brightlabs combines scientific expertise with advanced LC-MS/MS and GC-MS/MS systems for comprehensive nitrosamine analysis. Our laboratory utilizes multiple in-house screening methods, standardized procedures for common nitrosamines, and extensive experience with NDSRIs in complex pharmaceutical matrices.
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GC-MS/MS
Using liquid-liquid extraction, large-volume injection, and PTV injection, we achieve high extraction capacity, excellent selectivity, and very low limits of quantification, in some cases lower than 1 ppb in solution.
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LC-MS/MS
With various ionization techniques, including HESI and APCI, we strive for optimal sensitivity. Furthermore, HILIC methods support the analysis of highly polar compounds with low detection limits and good linearity.
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Ultra-low level detection
With seven advanced LC-MS/MS and GC-MS/MS systems, Brightlabs can perform accurate, sensitive, and efficient nitrosamine analyses for a wide range of pharmaceutical products.
Expertise
Reliability
Flexibility
Partnership
From screening to API-specific risk assessment.
The right approach to nitrosamine analysis varies by product, impurity, and regulatory requirement. Brightlabs supports pharmaceutical partners from broad screening to targeted NDSRI analysis and stress testing.
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Nitrosamine screening
Brightlabs has a validated generic screening method for a broad group of common nitrosamines. Depending on the product and the specific nitrosamine, detection limits below 1 ppb are often achievable using LC-MS/MS, GC-MS/MS, or a combination of both techniques.
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Identification of NDSRIs
Many small-molecule APIs contain secondary or tertiary amine groups that can form nitrosamine drug substance-related impurities. Brightlabs has extensive experience in the identification and analysis of these API-specific nitrosamines.
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Targeted method development
Brightlabs develops and validates targeted analytical methods for NDSRIs and supports clients throughout the market authorization process. Where necessary, reference standards for API-specific nitrosamines can be procured or synthesized.
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Modified NAP test
With our modified NAP test, we assess a product's susceptibility to nitrosamine formation under stress conditions. We use organic and inorganic nitrite sources to simulate realistic worst-case scenarios, followed by analysis using LC-MS/MS.
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Risk assessment
Brightlabs applies the EFPIA risk management framework to evaluate potential nitrosamine formation. This approach is applicable to both APIs and finished products, even when multiple amine groups are present.
Sectoren waar methodeontwikkeling essentieel is.
Insights from our laboratory
The complete overview of what Brightlabs does.
Download our brochure for a complete overview of our analytical capabilities, services, and scientific approach.
