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Nitrosamine Impurities

Reference standards for pharmaceutical analysis, method development, and ICH M7 compliance workflows.

✓ICH M7

✓Reference Standards

✓Method Validation

SIGMAK provides nitrosamine impurity reference standards to support pharmaceutical analysis, quality control, method development, validation, and regulatory testing in accordance with ICH M7 guidelines.

Showing 50 of 87 products

Reference standards for method development, validation, and ICH M7 workflows.Nitrosamine Catalog

Impurity Name	API Name	CAS No.
N-Nitroso-Ambroxol	AMBROXOL	N/A
N-Nitroso-N-Methyl-4-Aminobutyric Acid	AMINOBUTYRIC ACID	61445-55-4
N-Nitroso amoxapine	AMOXAPINE	N/A
N-Nitroso desmethylazithromycin	AZITHROMYCIN	N/A
N-Nitroso Benzylpenicillin EP - E	BENZYLPENICILLIN	N/A
N-Nitroso Benzylpenilloic Acid	BENZYLPENILLOIC	N/A
N-Nitroso Bilastine (Bilastine Nitroso Impurity 1)	BILASTINE	2731008-04-9
N-Nitroso bupivacaine (Desbutyl Bupivacaine Nitroso Impurity)	BUPIVACAINE	N/A
N-Nitroso Bupripion	BUPROPION	N/A
N-Nitroso-di-n-butylamine	BUTYLAMINE	924-16-3
N-nitrosoceliprolol	CELIPROLOL	N/A
N-Nitroso Ciprofloxacin	CIPROFLOXACIN	864443-44-7
N-Nitrosodimethylamine-D6	D6	17829-05-9
N-Nitroso N-Desmethyl DEBA	DEBA	N/A
N-Nitroso Desloratadine	DESLORATADINE	1246819-22-6
N-nitroso-N-desmethylnintedanib	DESMETHYLNINTEDANIB	N/A
N-Nitroso dobutamine	DOBUTAMINE	N/A
N-Nitroso doxepin	DOXEPIN	N/A
N-Nitroso azaerythromycin	ERYTHROMYCIN	N/A
N-Nitrosomethyl ethanolamine	ETHANOLAMINE	26921-68-6
N-Nitroso Flecainide	FLECAINIDE	N/A
N-Nitroso-Folic acid	FOLIC ACID	26360-21-4
N-Nitroso-calcium folinate-2	FOLINATE	N/A
N-Nitroso-calcium folinate-3	FOLINATE	N/A
N-Nitroso-Furosemide	FUROSEMIDE	N/A
N-nitroso Gatifloxacin Impurity 2	GATIFLOXACIN	N/A
N-Nitroso Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	63779-86-2
N-Nitroso hydroflumethiazide	HYDROFLUMETHIAZIDE	N/A
N-Nitroso Hydroxyzine	HYDROXYZINE	2005-04-1
N-Nitroso isavuconazonium sulfate	ISAVUCONAZONIUM	N/A
N-Nitroso Labetolol	LABETOLOL	N/A
N-Nitroso-Levofloxacin -1	LEVOFLOXACIN	1152314-62-9
N-Nitroso-calcium levofolinate 2	LEVOFOLINATE	N/A
N-Nitroso-Calcium levofolinate-3	LEVOFOLINATE	N/A
N-Nitroso Lidocaine EP impurity-B	LIDOCAINE	N/A
N-Nitroso linezolid	LINEZOLID	N/A
N-Nitroso-Meglumine	MEGLUMINE	62137-31-9
N-Nitroso-Meglumine	MEGLUMINE	10356-92-0
N-Nitroso Meropenem	MEROPENEM	N/A
N-Nitroso-N-methylaniline	METHYLANILINE	614-00-6
N-Nitroso-N-methylcyclohexylamine	METHYLCYCLOHEXYLAMINE	5432-28-0
N-Nitroso Midazolam Imp-A	MIDAZOLAM	59469-02-2
N-Nitroso nadolol	NADOLOL	N/A
N-Nitroso-di-n-butylamine (NDBA)	NDBA	924-16-3
N-Nitrosodiisopropylamine (NDIPA)	NDIPA	601-77-4
N-Nitroso-Nebivolol	NEBIVOLOL	1391051-68-5
N-Nitrosodibenzylamine	NITROSODIBENZYLAMINE	5336-53-8
N-Nitrosodicyclohexylamine	NITROSODICYCLOHEXYLAMINE	947-92-2
N-Nitrosodiethylamine	NITROSODIETHYLAMINE	55-18-5
N-Nitrosodiisopropylamine	NITROSODIISOPROPYLAMINE	601-77-4

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About Nitrosamine Impurities

SIGMAK provides a comprehensive range of nitrosamine impurity reference standards for pharmaceutical analysis and quality control. Our N-nitroso compounds are essential for method development, validation, and regulatory compliance testing in accordance with ICH M7 guidelines.

All nitrosamine impurity standards are manufactured in WHO-GMP certified facilities and supplied with complete analytical documentation including Certificate of Analysis (COA), spectral data, and characterization reports.

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Products offered are intended strictly for R&D, registration and/or export purposes only. The responsibility for ensuring that the product does not infringe any third-party patent or intellectual property rights in the destination country rests solely with the buyer.