United States Food and Drug Administration, Center of Drug Evaluation and Research/Office of Pharmaceutical Quality, 10903 New Hampshire Ave, Silver Spring, Maryland, 20993, USA.
United States Food and Drug Administration, Center of Drug Evaluation and Research/Office of Pharmaceutical Quality, 645 South Newstead Ave, Saint Louis, MO, 63110, USA.
AAPS J. 2023 Dec 19;26(1):7. doi: 10.1208/s12248-023-00877-4.
The FDA initiated a cross-sectional, statistically based sampling and testing study to characterize the quality of marketed alcohol-based hand sanitizer (ABHS) by evaluating the alcohol content and impurities present in ABHS products manufactured by establishments that registered with the FDA during March-April 2020. A stratified sampling design divided the population of manufacturers into independent groups based on each establishment's level of experience with FDA oversight and its geographic location. ABHS products were collected and analyzed by spatially offset Raman spectroscopy and gas chromatography with mass spectrometry (GC-MS). The GC-MS results for 310 products, from 196 newly registered domestic manufacturers, showed that 71.6% (± 5.7%) of these manufacturers had violative products. In 104 (33.5%) cases, the alcohol content did not meet label claim assay specifications but still fell within CDC efficacy ranges. Ethanol ABHS products failed more often overall (assay and impurities) (84.3%) and for impurities (84.3%), than isopropanol ABHS products (11.2% and 6.2%, respectively). Differences in test results across active ingredients were statistically significant. Ethanol ABHS products often (63.5% of cases) failed due to the presence of acetal or acetaldehyde, particularly in products with pH ≤ 6. Other impurities were also detected in several ABHS products, suggesting the use of low-grade alcohol in the manufacture of these products. Evidence was insufficient to conclude that having experience manufacturing FDA-regulated products, or lack thereof, influenced product-level violative results. This study highlights the importance of sourcing and testing active pharmaceutical ingredients to produce quality drug products.
美国食品药品监督管理局（FDA）开展了一项基于统计学的横断面抽样和测试研究，通过评估在 2020 年 3 月至 4 月期间向 FDA 注册的企业生产的酒精基手部消毒剂（ABHS）产品中的酒精含量和存在的杂质，来描述市售 ABHS 的质量特征。分层抽样设计根据每个企业接受 FDA 监管的经验水平及其地理位置，将制造商群体划分为独立的组。通过空间偏移拉曼光谱和气相色谱-质谱联用（GC-MS）对 ABHS 产品进行了采集和分析。从 196 家新注册的国内制造商中采集的 310 种产品的 GC-MS 结果显示，其中 71.6%（±5.7%）的制造商存在违规产品。在 104 种（33.5%）情况下，酒精含量不符合标签声称的检测规格，但仍在 CDC 功效范围内。乙醇 ABHS 产品在总体上（检测和杂质）（84.3%）以及杂质方面（84.3%）的失败率高于异丙醇 ABHS 产品（分别为 11.2%和 6.2%）。活性成分测试结果的差异具有统计学意义。由于存在缩醛或乙醛，乙醇 ABHS 产品经常（63.5%的情况下）失败，特别是在 pH 值≤6 的产品中。在几种 ABHS 产品中还检测到了其他杂质，这表明在这些产品的制造中使用了低等级的酒精。没有足够的证据来得出经验生产 FDA 监管产品或缺乏经验会影响产品层面违规结果的结论。本研究强调了采购和测试原料药以生产高质量药物产品的重要性。
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