Near-Infrared Spectrometry as a Tool for Screening Meropenem for Quality

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 &gt;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.<br>

注射用美罗培南（USP）为无菌、无热原的白色至淡黄色结晶性粉末，以瓶装供应，每瓶含足量美罗培南，可提供1g剂量用于静脉给药。肯塔基大学药物质量工作组发现，美罗培南样品的近红外光谱存在变异。该变异既存在于同批次内（6瓶样品中有1瓶与其余5瓶的偏差达12.0个标准差），也存在于不同批次间（8瓶样品与光谱库中心的偏差大于3个标准差，其中1瓶偏差达6.1个标准差）。该变异通过对光谱的统计分析得以检出，分析方法包括主成分分析（PCA）与BEST指标。批次间变异的评估采用了来自同一厂商15个批次的90瓶美罗培南样品构建的光谱库。研究结果提示，该药物的生产过程可能处于工艺控制范围之外。