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Pharma impurities
Overview
Confidently perform pharma impurity analyses and keep up with regulatory trends, to detect and identify nitrosamines, degradation products, and other impurities. Our systems were developed alongside analytical scientists, making them trusted and easy-to-use.
Nitrosamines
Workflow
Achieve robust, sensitive analysis of nitrosamines, impurities, and degradants with intuitive, trusted instruments, designed for you and backed by unwavering SCIEX support. Take the stress out of uncovering stability issues or degradation products in your samples. Reliably screen and monitor potential impurities, even at low abundance.
- Achieve robust and sensitive nitrosamine detection and identification
- Benefit from trusted and reliable instrument performance for nitrosamine analysis
- Simplify nitrosamine impurity analyses with intuitive, compliant-ready software
ExionLC AE system
Reproducibility, reliability and carryover performance to match your quantitative workflows. Dependability you can count on, from injection to injection and batch after batch.
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SCIEX Triple Quad 6500+ system
Delivering the perfect balance of speed, performance, and sensitivity for your most challenges analytes.
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SCIEX OS software
Unleash the analytical power of the next-generation software platform for data acquisition and processing.
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Service
Keep your instruments performing at their peak, with multiple options for response time, repair coverage and maintenance.
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Nitrosamines
Suited for:
- Challenging nitrosamine analysis requires the mass resolution of a time-of-flight instrument
ExionLC AE system
Reproducibility, reliability and carryover performance to match your quantitative workflows. Dependability you can count on, from injection to injection and batch after batch.
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X500R QTOF system
A uniquely engineered and versatile QTOF build to handle the demands of any high throughput laboratory.
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SCIEX OS software
Unleash the analytical power of the next-generation software platform for data acquisition and processing.
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Service
Keep your instruments performing at their peak, with multiple options for response time, repair coverage and maintenance.
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Featured resources
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Technical note
Sensitive and reproducible quantitation of N-nitroso propranolol in a propranolol drug substance and product
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.
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Technical note
Low-level quantitation of 10 mutagenic nitrosamine impurities in acyclovir
This technical note demonstrates a highly selective and sensitive method for quantifying 10 nitrosamines in acyclovir and meeting critical requirements for nitrosamine analysis.
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Technical note
Low-level quantitation of 10 mutagenic nitrosamine impurities in pioglitazone hydrochloride using accurate mass spectrometry
This technical note presents an accurate mass spectrometry method for quantifying 10 mutagenic nitrosamines in pioglitazone hydrochloride, including NDMA.
Impurities
Workflow
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.
- Confidently find stability issues and degredation products
- Reliably screen and monitor even low-abundance impurities
Impurities
ExionLC AE system
Reproducibility, reliability and carryover performance to match your quantitative workflows. Dependability you can count on, from injection to injection and batch after batch.
Learn more
X500R QTOF system
A uniquely engineered and versatile QTOF build to handle the demands of any high throughput laboratory.
Learn more
SCIEX OS software
Unleash the analytical power of the next-generation software platform for data acquisition and processing.
Learn more
Service
Keep your instruments performing at their peak, with multiple options for response time, repair coverage and maintenance.
Learn more
All resources
Filter:
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Blog
What have we learned from the nitrosamine crisis? - SCIEX Community
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
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Webinar
Webinar
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.
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Technical note
Highly selective and sensitive method for quantification of nitrosamines in valsartan drug substance
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.
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Technical note
Sensitive and reproducible quantitation of N-nitroso propranolol in a propranolol drug substance and product
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.
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Technical note
Low-level quantitation of 10 mutagenic nitrosamine impurities in acyclovir
This technical note demonstrates a highly selective and sensitive method for quantifying 10 nitrosamines in acyclovir and meeting critical requirements for nitrosamine analysis.
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Technical note
Low-level quantitation of 10 mutagenic nitrosamine impurities in pioglitazone hydrochloride using accurate mass spectrometry
This technical note presents an accurate mass spectrometry method for quantifying 10 mutagenic nitrosamines in pioglitazone hydrochloride, including NDMA.
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Technical note
Impurity profiling of amiodarone stability samples using accurate mass analysis and automated data processing
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.
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Technical note
Identification and sensitive quantitation of N-nitroso N-desmethyl orphenadrine impurity in orphenadrine citrate API
This technical note demonstrates a sensitive method for the identification and quantitation of N-nitroso N-desmethyl orphenadrine (NNDO) impurity in orphenadrine citrate (OC) API using the QTRAP version of the SCIEX 7500 system. A limit of quantitation (LOQ) of 2.5 pg/mL was achieved with baseline separation of NNDO and OC.
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Technical note
Sensitive quantitation of N-nitroso Pyribenzamine isomeric impurities in Tripelennamine hydrochloride API
Read more about how it was possible to analyze NNPBA 1 and NNPBA 2 at 0.01 ng/mg of API, below the calculated specification limit of 0.03 ng/mg
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Extractables and leachables
Support the safety and security of packaged drug substances and drug products with highly sensitive solutions that detect, identify and quantify packaging-related extractables and leachables.
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