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Development and Validation of 2-Azaspiro [4,5] Decan-3-One (Impurity A) in Gabapentin Determination Method Using qNMR Spectroscopy

The authors developed a (1)H qNMR test procedure for identification and quantification of impurity A present in gabapentin active pharmaceutical ingredient (API) and gabapentin products. The validation studies helped to determine the limit of quantitation and assess linearity, accuracy, repeatabilit...

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Detalles Bibliográficos
Autores principales: Kuz’mina, Nataliya E., Moiseev, Sergey V., Khorolskiy, Mikhail D., Lutceva, Anna I.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8002367/
https://www.ncbi.nlm.nih.gov/pubmed/33809747
http://dx.doi.org/10.3390/molecules26061656