Nitrosamines Analysis
Nitrosamines are compounds of the chemical structure where hydrogen of the amine nitrogen is substituted with a nitroso group. These compounds are widely used industrially in plasticizers, additives, etc., but at least some of them are known to be carcinogenic.
Nitrosamine are also formed by reaction of secondary amine and nitrous acid. Therefore, they are often detected as impurities during the manufacturing process of a drug product. Recently, nitrosamines were detected in some sartan and ranitidine products, and these products were recalled. In response to this event, 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. Fujifilm Wako offers a wide range of analytical standards of nitrosamines.
10 Nitrosamines Mixture Standard Solution
Feature
Mixture standard solution of 10 nitrosamines regulated by USP, Ph. Eur., and EMA!
LC/MS Chromatogram (Positive Mode)
| Peak No. | Nitrosamine | Monitoring ion (m/z) | Mode | Peak No. | Nitrosamine | Monitoring ion (m/z) | Mode |
|---|---|---|---|---|---|---|---|
| 1 | MeNP | 130 | + | 6 | NIPEA | 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)
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℃
* 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).
* NMBA is rarely detected in GC/MS.
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 | MeNP | |
| CAS RN® | 59-89-2 | 16339-07-4 |
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Mixture Standard Solution
Analytical Standard
Stable Isotopes
For research use or further manufacturing use only. Not for use in diagnostic procedures.
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