10 Nitrosamines Mixture Standard Solution (each 2μg/mL Methanol Solution)

for Chromatography

Manufacturer :: FUJIFILM Wako Pure Chemical Corporation

Storage Condition :: Keep at -20 degrees C.

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	Distributor 145-10051 Barcode No 4548995091802	1mL x5A	Inquire	In stock in Japan	Certificate of Analysis

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1mL x5A

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Overview / Applications

Outline	Nitrosamines are a group of compounds with a structure in which a hydrogen bound to the amine nitrogen is replaced by a nitroso group, and some of these compounds are known to be carcinogenic. Nitrosamines are also formed as a reaction product of secondary amines and nitrous acid, so they can be detected as impurities in the manufacturing process of pharmaceuticals and are controlled under ICH M7 (Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk). In recent years, there have been cases of nitrosamines being detected in sartan and latinidine drugs, resulting in recalls. In response, in September 2019, the EMA (European Medicines Agency) requested the marketing authorization holders to evaluate the risk of the presence of nitrosamine impurities in their drugs and take appropriate risk mitigation measures. Composition: NDMA, NDEA, NEIPA, NDPA, NDIPA, NDBA, NMBA, NMPA, MNP, NMOR (each 2 ppm Methanol Solution)

Outline

Nitrosamines are a group of compounds with a structure in which a hydrogen bound to the amine nitrogen is replaced by a nitroso group, and some of these compounds are known to be carcinogenic.
Nitrosamines are also formed as a reaction product of secondary amines and nitrous acid, so they can be detected as impurities in the manufacturing process of pharmaceuticals and are controlled under ICH M7 (Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk).
In recent years, there have been cases of nitrosamines being detected in sartan and latinidine drugs, resulting in recalls. In response, in September 2019, the EMA (European Medicines Agency) requested the marketing authorization holders to evaluate the risk of the presence of nitrosamine impurities in their drugs and take appropriate risk mitigation measures.
Composition: NDMA, NDEA, NEIPA, NDPA, NDIPA, NDBA, NMBA, NMPA, MNP, NMOR (each 2 ppm Methanol Solution)

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Appearance	Colorless clear liquid

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Product List

Product Name
6 Nitrosamines Mixture Standard Solution (each 2μg/mL Methanol Solution)	for Chromatography
4-(Methylnitrosoamino)-1-(3-pyridinyl)-1-butanone Standard (mixture of isomers)	for Chromatography
N-Methyl-N-nitrosophenethylamine Standard (mixture of isomers)	for Chromatography
N-Nitrosodi-n-butylamine Standard	for Chromatography
N-Nitrosoethylisopropylamine Standard	for Chromatography
N-Nitrosodiethanolamine Standard	for Chromatography
N-Nitrosodiethylamine Standard	for Chromatography
N-Nitrosodiisopropylamine Standard	for Chromatography
N-Nitrosodiphenylamine Standard	for Chromatography
N-Nitrosodi-n-propylamine Standard	for Chromatography
N-Nitrosomethylaminobutyric Acid Standard	for Chromatography
N-Nitrosomethylethylamine Standard	for Chromatography
N-Nitrosomethylphenylamine Standard	for Chromatography
N-Nitroso-N '-methylpiperazine Standard	for Chromatography
N-Nitrosomorpholine Standard	for Chromatography
N-Nitrosopiperidine Standard	for Chromatography
N-Nitrosopyrrolidine Standard	for Chromatography
N-Nitrosodiethylamine-d10 Standard	for Chromatography

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