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>