Información adicional sobre el N-Nitroso Metronidazole EP Impurity B
Fármaco de origen
Metronidazole
Nombre IUPAC
4-nitro-1-nitroso-1H-imidazole
Sinónimos farmacopeicos
N/A
Otros sinónimos
N/A
SMILES
O=NN1C=C([N+]([O-])=O)N=C1
InChI
InChI=1S/C3H2N4O3/c8-5-6-1-3(4-2-6)7(9)10/h1-2H
Descripción
N-Nitroso Metronidazole EP Impurity B es una nitrosamina derivada del metronidazol identificada como impureza crítica en la Farmacopea Europea; su presencia exige un control riguroso por su potencial riesgo genotóxico. Se forma por nitrosación de aminas secundarias en presencia de nitritos bajo condiciones ácidas | térmicas o durante procesos de síntesis y almacenamiento. Su detección requiere métodos analíticos sensibles y específicos como LC-MS/MS y GC-MS con límites de cuantificación en rango de ppb | validación de selectividad y precisión. Las estrategias de control incluyen optimización de procesos | control de nitritos en materias primas | medidas de neutralización y criterios de especificación y muestreo conformes a directrices regulatorias.
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To provide the best experiences, we use technologies like cookies to store and/or access device information. Consenting to these technologies will allow us to process data such as browsing behavior or unique IDs on this site. Not consenting or withdrawing consent, may adversely affect certain features and functions.
Functional
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The technical storage or access is strictly necessary for the legitimate purpose of enabling the use of a specific service explicitly requested by the subscriber or user, or for the sole purpose of carrying out the transmission of a communication over an electronic communications network.
Preferences
The technical storage or access is necessary for the legitimate purpose of storing preferences that are not requested by the subscriber or user.
Statistics
The technical storage or access that is used exclusively for statistical purposes.The technical storage or access that is used exclusively for anonymous statistical purposes. Without a subpoena, voluntary compliance on the part of your Internet Service Provider, or additional records from a third party, information stored or retrieved for this purpose alone cannot usually be used to identify you.
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The technical storage or access is required to create user profiles to send advertising, or to track the user on a website or across several websites for similar marketing purposes.
