Isaacs James T, Almeter Philip J, Hunter Aaron N, Lyman Thomas A, Zapata Stephanie P, Henderson Bradley S, Larkin Seth A, Hasani Eleonora, Yoon Uiyeol, Crumrin Adler, Smith Jerod, Pergrem Spencer, Plymale Ashton, Ramnes Bailee, Melson Joshua D, Reynolds Jeffrey W, Relucio Eunice, Bossle Megan, Lozier Austin, Long Lindsey, Knight Reagan, Naseman Ryan W, Platt Thomas L, Lodder Robert A
Department of Pharmacy Services, University of Kentucky HealthCare, Lexington, KY 40536.
Pharmacy Practice & Sciences, College of Pharmacy, University of Kentucky, Lexington, KY 40536.
Contact Context. 2025;2025. doi: 10.6084/m9.figshare.28830275. Epub 2025 Apr 21.
Meropenem for Injection, USP is a sterile, pyrogen-free, white to pale yellow crystalline powder and is supplied in vials containing sufficient meropenem to deliver 1 g for intravenous administration. The Drug Quality Task Force at the University of Kentucky has found variability in the near-infrared spectra of meropenem samples. The variability was found both within a lot (where one vial from six was 12.0 SDs from the other 5 vials) and between lots of the drug (where 8 vials were >3 SDs from the center of the library, and one of those was 6.1 SDs away from the center of the library). This variability was detected using a statistical analysis of the spectra that included principal component analysis (PCA) and the BEST metric. Inter-lot variability was assessed using a spectral library of 90 meropenem vials obtained from 15 lots of drug from the same manufacturer. The results suggest that the drug may have been manufactured while the manufacturing process was operating outside of a state of process control.
注射用美罗培南，美国药典标准，是一种无菌、无热原的白色至淡黄色结晶性粉末，装于小瓶中，每瓶含有足够用于静脉给药的1g美罗培南。肯塔基大学的药品质量工作组发现美罗培南样品的近红外光谱存在变异性。这种变异性在同一批次内（六个小瓶中的一个与其他五个小瓶相差12.0标准差）以及不同批次的药品之间（八个小瓶偏离光谱库中心大于3标准差，其中一个偏离光谱库中心6.1标准差）均被发现。这种变异性是通过对光谱进行包括主成分分析（PCA）和BEST指标的统计分析检测到的。使用从同一制造商的15批药品中获取的90个美罗培南小瓶的光谱库评估批次间变异性。结果表明，该药品可能是在生产过程处于非过程控制状态下生产的。
