Overview
Confidently perform pharma impurity analyses to detect and identify nitrosamines, degradation products, and other impurities. Our systems were developed alongside our customers, making them trusted and easy-to-use. These technical developments are based on a solid foundation of robust and sensitive instrument performance and are supported with dependable service and technical support.
Workflow
Nitrosamines
Complete nitrosamine impurity analysis with confidence, using fit-for-purpose solutions that provide robust sensitivity. Simplify this important analytical task using SCIEX OS software, a compliant-ready software platform that is easy-to-use for data acquisition, processing and reporting.
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Achieve robust and sensitive nitrosamine detection and identification
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Benefit from trusted and reliable instrument performance for nitrosamine analysis
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Simplify nitrosamine impurity analyses with intuitive, compliant-ready software
Nitrosamines
Solution
ExionLC AE system
SCIEX Triple Quad 6500+ system
SCIEX OS software
Service
Nitrosamines
Solution
- Challenging nitrosamine analysis requires the mass resolution of a time-of-flight instrument
ExionLC AE system
X500R QTOF system
SCIEX OS software
Service
Featured resources
See the quantitation of the N-nitroso propranolol impurity in a propranolol drug substance with a lower limit of quantitation of 0.01 ng/mL with high reproducibility and accuracy.
This technical note demonstrates a highly selective and sensitive method for quantifying 10 nitrosamines in acyclovir and meeting critical requirements for nitrosamine analysis.
Workflow
Impurities
Alleviate the burden of finding stability issues or degradation products in your drug candidates. Reliably screen and monitor potential impurities, even those present in low abundance, with the SCIEX X500R QTOF system.
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Confidently find stability issues and degredation products
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Reliably screen and monitor even low-abundance impurities
Impurities
Solution
ExionLC AE system
X500R QTOF system
SCIEX OS software
Service
Featured resources
Review an integrated hardware and software solution with high sensitivity, resolution and mass accuracy that can generate critical data for routine and automated identification of drug impurities.
All resources
Read about recent issues with nitrosamine impurities in drug products and the need for more comprehensive impurity-monitoring strategies. Here we describe a general approach to targeted, quantitative LC-MS/MS analysis of
Observe a presentation on the benefits of information-dependent acquisition (IDA) workflows for LC-MS analysis of nitrosamine impurities, including specific assays for nitrosamine detection in various drug products.
We introduce an easy-to-implement method for the accurate detection and quantitation of six specific nitrosamines at levels well below current FDA action limits in valsartan APIs.
See the quantitation of the N-nitroso propranolol impurity in a propranolol drug substance with a lower limit of quantitation of 0.01 ng/mL with high reproducibility and accuracy.
This technical note demonstrates a highly selective and sensitive method for quantifying 10 nitrosamines in acyclovir and meeting critical requirements for nitrosamine analysis.
This technical note presents an accurate mass spectrometry method for quantifying 10 mutagenic nitrosamines in pioglitazone hydrochloride, including NDMA.
Review an integrated hardware and software solution with high sensitivity, resolution and mass accuracy that can generate critical data for routine and automated identification of drug impurities.