Saraf Isha, Kushwah Varun, Werner Bernd, Zangger Klaus, Paudel Amrit
Research Center Pharmaceutical Engineering GmbH, Inffeldgasse 13, 8010 Graz, Austria.
Institute of Chemistry, University of Graz, Heinrichstr. 28, 8010 Graz, Austria.
Polymers (Basel). 2025 Mar 11;17(6):739. doi: 10.3390/polym17060739.
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.
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.
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.
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.
药品和辅料中的过氧化物会通过氧化药物分子带来风险，导致潜在毒性并降低疗效。准确的过氧化物定量对于确保产品安全性和效力至关重要。本研究探索使用定量质子核磁共振（H qNMR）光谱法作为一种灵敏且特异的方法来定量药品辅料中的过氧化物水平。
采用H qNMR光谱法测量辅料中低至0.1 ppm的过氧化物水平，重点关注聚乙烯吡咯烷酮（PVP）和聚乙烯吡咯烷酮/醋酸乙烯酯（PVPVA）。分析了不同等级和供应商的产品，并考察了各种制造工艺对过氧化氢含量的影响。
不同等级的PVP和PVPVA以及不同供应商之间的过氧化物水平存在差异。此外，制造工艺会影响所选辅料中的过氧化氢含量。这些差异凸显了在原材料和生产过程中控制过氧化物水平的重要性。
H qNMR光谱法是准确量化药品辅料中过氧化物水平的宝贵工具。该研究强调需要定期监测过氧化物含量，以确保辅料和药品的稳定性、质量及安全性。准确的过氧化物测量可防止氧化降解，保持药物制剂的安全性和有效性。
