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

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

The authors developed a <sup>1</sup>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, a...

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Bibliographic Details
Main Authors: Nataliya E. Kuz’mina, Sergey V. Moiseev, Mikhail D. Khorolskiy, Anna I. Lutceva
Format: Article
Language:English
Published: MDPI AG 2021-03-01
Series:Molecules
Subjects:
gabapentin
impurity A
validation
limit of the quantitation
linearity
accuracy
Online Access:https://www.mdpi.com/1420-3049/26/6/1656

Internet

https://www.mdpi.com/1420-3049/26/6/1656

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