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Article Abstract
Objective: Peroxides in pharmaceutical products and excipients pose risks by oxidizing drug molecules, leading to potential toxicity and reduced efficacy. Accurate peroxide quantification is essential to ensure product safety and potency. This study explores the use of quantitative proton nuclear magnetic resonance (H qNMR) spectroscopy as a sensitive and specific method for quantifying peroxide levels in pharmaceutical excipients.
Methods: H qNMR spectroscopy was employed to measure peroxide levels down to 0.1 ppm in excipients, focusing on poly(vinylpyrrolidone) (PVP) and polyvinylpyrrolidone/vinyl acetate (PVPVA). Different grades and vendors were analyzed, and the impact of various manufacturing processes on hydrogen peroxide content was examined.
Results: Peroxide levels varied among different grades of PVP and PVPVA, as well as between vendors. Furthermore, manufacturing processes influenced the hydrogen peroxide content in selected excipients. These variations highlight the importance of controlling peroxide levels in raw materials and during production.
Conclusions: H qNMR spectroscopy is a valuable tool for accurately quantifying peroxide levels in pharmaceutical excipients. The study emphasizes the need for regular monitoring of peroxide content to ensure the stability, quality, and safety of excipients and drug products. Accurate peroxide measurement can prevent oxidative degradation, preserving both the safety and efficacy of pharmaceutical formulations.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11945108 | PMC |
| http://dx.doi.org/10.3390/polym17060739 | DOI Listing |
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