Synthesis and Characterization of Pregabalin Impurity G of an Anticonvulsant Drug, Pregabalin

In this study, Pregabalin Impurity G—which was created for the first time with a high yield and exceptional purity—is synthesized and characterized. A dependable route for laboratory and possibly industrial applications was established by optimizing the synthetic technique to guarantee efficiency and reproducibility. The synthesized impurity's high chemical integrity and suitability for analytical investigations were confirmed by a purity assessment utilizing High-Performance Liquid Chromatography (HPLC). The molecular structure and functional groups were confirmed in detail by mass spectrometry and proton nuclear magnetic resonance (1H NMR) spectroscopy, which were used to further elucidate the structure. With great accuracy, the impurity's identity was confirmed by these combined procedures Pregabalin Impurity G's successful manufacture and thorough characterization are highly valuable for pharmaceutical quality control, regulatory filings, and future studies that aim to comprehend drug metabolism, degradation routes, and guarantee safety in therapeutic formulations.

Publication Details

Journal
Zenodo (CERN European Organization for Nuclear Research)
Published
2025-08-31
DOI
https://doi.org/10.5281/zenodo.17182484
Primary Topic
Geochemistry and Geologic Mapping
Type
article
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article

Synthesis and Characterization of Pregabalin Impurity G of an Anticonvulsant Drug, Pregabalin

Zenodo (CERN European Organization for Nuclear Research)
Geochemistry and Geologic Mapping
article

Synthesis and Characterization of Pregabalin Impurity G of an Anticonvulsant Drug, Pregabalin

article en

Abstract

In this study, Pregabalin Impurity G—which was created for the first time with a high yield and exceptional purity—is synthesized and characterized. A dependable route for laboratory and possibly industrial applications was established by optimizing the synthetic technique to guarantee efficiency and reproducibility. The synthesized impurity's high chemical integrity and suitability for analytical investigations were confirmed by a purity assessment utilizing High-Performance Liquid Chromatography (HPLC). The molecular structure and functional groups were confirmed in detail by mass spectrometry and proton nuclear magnetic resonance (1H NMR) spectroscopy, which were used to further elucidate the structure. With great accuracy, the impurity's identity was confirmed by these combined procedures Pregabalin Impurity G's successful manufacture and thorough characterization are highly valuable for pharmaceutical quality control, regulatory filings, and future studies that aim to comprehend drug metabolism, degradation routes, and guarantee safety in therapeutic formulations.

Zenodo (CERN European Organization for Nuclear Research)
Industry, innovation and infrastructure
Openalex Percentile: Top 30%
Geochemistry and Geologic Mapping
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Synthesis and Characterization of Pregabalin Impurity G of an Anticonvulsant Drug, Pregabalin · Zenodo (CERN European Organization for Nuclear Research) (2025) | TGRS Research Map | TGRS