Supporting Accurate Detection and Quantification of Nitrosamine Impurities
Nitrosamine impurities have become an important focus within pharmaceutical quality control and analytical testing. Because many nitrosamines are classified as probable human carcinogens, regulatory agencies worldwide have established stringent limits for their presence in pharmaceutical products. Reliable detection and accurate quantification are therefore essential to ensure drug quality and minimize potential long-term patient risks associated with nitrosamine exposure.
Nitrosamine reference standards are critical analytical tools for the identification, characterization, and quantification of these potentially hazardous contaminants. This includes nitrosamine drug substance-related impurities (NDSRIs), which can form from the active pharmaceutical ingredient during its production, from excipients, or other components of a drug product under certain conditions.
The Importance of Stable Isotope-Labeled Reference Standards
As analytical methods become increasingly sensitive, laboratories require reference materials capable of supporting the precise measurement of nitrosamines at very low concentrations. Stable isotope-labeled nitrosamine standards offer significant advantages when used as internal standards in mass spectrometric techniques. Because the labeled and unlabeled compounds have highly similar chemical and physical properties, stable isotope-labeled internal standards can help compensate for variability throughout the analytical process. They can account for factors such as sample preparation, extraction efficiency, matrix effects, and instrument response, improving the reliability and reproducibility of quantitative results. The use of stable isotope-labeled standards is particularly valuable when laboratories are working at trace levels, where even small variations in sample handling or instrument performance can affect analytical results.
Expanding Our Nitrosamine Reference Standard Portfolio
In response to the continuing need for high-quality analytical reference materials, we are expanding our portfolio of stable isotope-labeled nitrosamine drug impurity reference standards.
Our current offering includes:
Desethyl Amiodarone-D4 N-Nitroso [A-41212-01]
Betahistine Methyl Impurity N-Nitroso-13CD3 [B-30312-02]
Bepotastine Impurity A-D5 N-Nitroso [B-50917-02]
Cetirizine EP Impurity A-D8 N-Nitroso [C-60303-01]
Clopidogrel 2-chloro Impurity-D4 N-Nitroso [C-60127-02]
Clopidogrel Thieno Impurity D4 N-Nitroso [C-60127-01]
Clozapine EP Impurity C-D8 N-Nitroso [C-41004-01]
Fluvoxamine EP Impurity C-D4 N-Nitroso [F-40820-03]
Fluvoxamine EP Impurity F-D4 N-Nitroso [F-40820-02]
Aminoethyl Desmethoxy Fluvoxamine-D4 N-Nitroso [F-40820-01]
N-desmethyl Doxepin-D3 N-Nitroso [D-51105-01]
N-Desmethylnintedanib-D8 N-Nitroso [N-40528-02]
Doxepin EP Impurity B N-desmethyl-D6 N-Nitroso [D-50918-01]
N-desmethyl Galantamine-13CD3 N-Nitroso [G-41120-01]
Mirtazapine N-desmethyl-D4 N-Nitroso [M-51015-01]
Moxonidine-D3 N-Nitroso N1 [M-50204-01]
Prazosin EP Impurity C-D8 N-Nitroso [P-60812-01]
Quetiapine HEEP Impurity-D8 N-Nitroso [Q-51126-01]
N-Desmethyl Rivastigmine USP RC B-D3 N-Nitroso [R-60601-01]
Rotigotine USP RC C-D5 N-Nitroso [R-40821-01]
Rotigotine EP Impurity B-D5 N-Nitroso [R-40821-02]
Scopolamine N-desmethyl-D5 N-Nitroso [S-51028-01]
Trospium EP Impurity B-D10 N-Nitroso [T-60130-02]
Venlafaxine Impurity H-13CD3 N-Nitroso [V-51028-01]
N-desmethylvenlafaxine-D3 N-Nitroso [V-50917-01]
N-desmethyldesvenlafaxine-D3 -N-Nitroso [V-50826-01]
Ziprasidone EP Impurity A-D8 N-Nitroso [Z-30503-01]
Our standards are intended to support pharmaceutical manufacturers, contract testing laboratories, analytical laboratories, and other research organizations involved in nitrosamine impurity testing and pharmaceutical quality assessment.
Supporting Evolving Nitrosamine Testing Requirements
The analytical landscape surrounding nitrosamine impurities continues to evolve. As new potential impurities are identified and regulatory expectations develop, laboratories must be prepared to expand their testing capabilities and address an increasingly broad range of compounds. We recognize that a standard catalog cannot always meet every analytical requirement. For this reason, we are continuously adding new stable isotope-labeled nitrosamine standards to our portfolio and can also support custom stable isotope labeling projects for compounds that may not yet be commercially available. Our goal is to provide researchers and analytical scientists with reliable reference materials that support sensitive, accurate, and reproducible nitrosamine analysis.
Whether you require an established nitrosamine internal standard or have a specific NDSRI or other impurity that requires customized stable isotope labeling, our team can work with you to identify an appropriate solution.