Nitrosamines Mixture Standard Solutions

02128_img01.png

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.

We offer a wide range of analytical standards and mixture standard solutions for nitrosamines of various structures*1, 2.

This page introduces the mixture standard solutions for nitrosamines regulated by USP, Ph. Eur. and EMA.

*1 This product is not JP / Ph. Eur. / USP reference standard.
*2 Please refer to the following page for information on single analytical standard.

10 Nitrosamines Mixture Standard Solution

Feature

Mixture standard solution of 10 nitrosamines regulated by USP, Ph. Eur., and EMA!

LC/MS Chromatogram (Positive Mode)

02128_img36.png

Peak No. Nitrosamine Monitoring ion (m/z) Mode Peak No. Nitrosamine Monitoring ion (m/z) Mode
1 MNP 130 + 6 NEIPA 117 +
2 NDMA 75 + 7 NDIPA 131 +
3 NMOR 117 + 8 NMPA 137 +
4 NMBA 147 + 9 NDPA 131 +
5 NDEA 103 + 10 NDBA 159 +

Analysis conditions

[ Internal Standard ]

N-Nitrosomethylethylamine Standard

[HPLC]
Column
Wakopak® Ultra C18-3 4.6 × 150 mm
Column temperature
40℃
Eluent
A) 0.1 vol% HCOOH in H2O,  B) 0.1 vol% HCOOH in CH3OH
Gradient
Time (min.) B conc. (%)
0-30 10-95
30-40 95
Flow rate
0.5 mL/min.
[MS]
Ionization
ESI
Mode
SIM

GC/MS Chromatogram (Positive Mode)*1

02128_img38.png

Analysis conditions

[ Internal Standard ]

N-Nitrosomethylethylamine Standard

[GC]
Column
DB-624UI 0.14 μm, 0.25 mm × 30 m
Column temperature
40℃ (5 min.)→5℃/min.→260℃ (11 min.)
Injection temperature
260℃
Carrier gas
He 1.3 mL/min.
Splitless
1 min.
[MS]
Ionization
EI
Interface temperature
250℃

*1 NMBA is rarely detected in GC/MS.
*2 Since NMPA is easily decomposed under thermal conditions1), it is detected as a decomposition peak under this conditions.
1) Mutsuga, M. et al.: Am. J. Anal. Chem., 4, 277 (2013).

CAS RN® and Abbreviation

Structural
formula
02128_img18.png
02128_img19.png
02128_img20.png
Chemical name N-Nitrosodimethylamine N-Nitrosomethylethylamine N-Nitrosodiethylamine
Abbreviation NDMA NEMA NDEA
CAS RN® 62-75-9 10595-95-6 55-18-5
Structural
formula
02128_img21.png
02128_img35.png
02128_img23.png
Chemical name N-Nitrosodiethanolamine N-Nitrosoethylisopropylamine N-Nitrosodi-n-propylamine
Abbreviation NDELA NIPEA, NEIPA NDPA
CAS RN® 1116-54-7 16339-04-1 621-64-7
Structural
formula
02128_img24.png
02128_img25.png
02128_img26.png
Chemical name N-Nitrosodiisopropylamine N-Nitrosodi-n-butylamine N-Nitrosomethylaminobutyric Acid
Abbreviation NDIPA NDBA NMBA
CAS RN® 601-77-4 924-16-3 61445-55-4
Structural
formula
02128_img27.png
02128_img28.png
02128_img29.png
Chemical name N-Nitrosomethylphenylamine N-Nitrosodiphenylamine N-Methyl-N-nitrosophenethylamine
Abbreviation NMPA NDPh NMPEA
CAS RN® 614-00-6 86-30-6 13256-11-6
Structural
formula
02128_img30.png
02128_img31.png
02128_img32.png
Chemical name 4-(Methylnitrosoamino)-1-(3-pyridinyl)-1-butanone N-Nitrosopyrrolidine N-Nitrosopiperidine
Abbreviation NNK NPYR NPIP
CAS RN® 64091-91-4 930-55-2 100-75-4
Structural
formula
02128_img33.png
02128_img34.png
Chemical name N-Nitrosomorpholine N-Nitroso-N'-methylpiperazine
Abbreviation NMOR MeNP
CAS RN® 59-89-2 16339-07-4

Product List

  • Open All
  • Close All

Mixture Standard Solution

Analytical Standard

Stable Isotopes

For research use or further manufacturing use only. Not for use in diagnostic procedures.

Product content may differ from the actual image due to minor specification changes etc.

If the revision of product standards and packaging standards has been made, there is a case where the actual product specifications and images are different.