Nitrosamines Mixture Standard Solutions
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.
Composition
| Nitrosamine | Abbreviation | CAS | 145-10051 | 142-10201 |
|---|---|---|---|---|
| 4-(Methylnitrosoamino)-1-(3-pyridinyl)-1-butanone | NNK | 64091-91-4 | - | 2 |
| N-Methyl-N-nitrosophenethylamine | NMPEA | 13256-11-6 | - | 2 |
| N-Nitrosodi-n-butylamine | NDBA | 924-16-3 | 2 | - |
| N-Nitrosodiethanolamine | NDELA | 1116-54-7 | - | 2 |
| N-Nitrosodiethylamine | NDEA | 55-18-5 | 2 | - |
| N-Nitrosodiisopropylamine | NDIPA | 601-77-4 | 2 | - |
| N-Nitrosodimethylamine | NDMA | 62-75-9 | 2 | - |
| N-Nitrosodiphenylamine | NDPh | 86-30-6 | - | 2 |
| N-Nitrosodi-n-propylamine | NDPA | 621-64-7 | 2 | - |
| N-Nitrosoethylisopropylamine | NEIPA | 16339-04-1 | 2 | - |
| N-Nitrosomethylaminobutyric Acid | NMBA | 61445-55-4 | 2 | - |
| N-Nitrosomethylphenylamine | NMPA | 614-00-6 | 2 | - |
| N-Nitroso-N'-methylpiperazine | MNP | 16339-07-4 | 2 | - |
| N-Nitrosomorpholine | NMOR | 59-89-2 | 2 | - |
| N-Nitrosopiperidine | NPIP | 100-75-4 | - | 2 |
| N-Nitrosopyrrolidine | NPYR | 930-55-2 | - | ２ |
10 Nitrosamines Mixture Standard Solution
LC/MS Chromatogram (Positive Mode)
| 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
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).
6 Nitrosamines Mixture Standard Solution
6 Nitrosamines Mixture Standard SolutionLC/MS Chromatogram (Positive Mode)
| Peak No. | Nitrosamine | Monitoring ion (m/z) | Mode | Peak No. | Nitrosamine | Monitoring ion (m/z) | Mode |
|---|---|---|---|---|---|---|---|
| 1 | NDELA | 135 | + | 4 | NPIP | 115 | + |
| 2 | NPYR | 101 | + | 5 | NMPEA | 165 | + |
| 3 | NNK | 208 | + | 6 | NDPh | 199 | + |
Analysis conditions
[ Internal Standard ]
N-Nitrosodimethylamine 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
CAS RN® and Abbreviation
| Structural formula |
 |
 |
 |
| 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 |
 |
 |
 |
| 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 |
 |
 |
 |
| 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 |
 |
 |
 |
| 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 |
 |
 |
 |
| 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 |
 |
 |
|
| Chemical name | N-Nitrosomorpholine | N-Nitroso-N'-methylpiperazine | |
| Abbreviation | NMOR | MNP | |
| CAS RN® | 59-89-2 | 16339-07-4 |
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Mixture Standard Solution
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Stable Isotopes
For research use or further manufacturing use only. Not for use in diagnostic procedures.
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