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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1mL x5A
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In stock in Japan |
Document
Application
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) |
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Property
| Appearance | Colorless clear liquid |
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Manufacturer Information
Alias
For research use or further manufacturing use only. Not for use in diagnostic procedures.
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