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

Area of Science:

• Pharmaceutical Science
• Analytical Chemistry

Background:

• Meropenem for Injection, USP is a sterile powder for intravenous administration.
• Ensuring consistent drug quality is critical for patient safety and therapeutic efficacy.

Purpose of the Study:

• To investigate variability in the near-infrared (NIR) spectra of meropenem samples.
• To assess potential deviations in the manufacturing process based on spectral data.

Main Methods:

• Utilized near-infrared spectroscopy to analyze meropenem vials.
• Employed statistical analysis, including principal component analysis (PCA) and the BEST metric.
• Assessed inter-lot variability using a spectral library of 90 meropenem vials from 15 lots.

Main Results:

• Significant variability was observed in NIR spectra, both within individual lots and between different lots.
• One vial showed a deviation of 12.0 standard deviations (SDs) within a lot.
• Eight vials exceeded 3 SDs from the library center between lots, with one being 6.1 SDs away.

Conclusions:

• The detected spectral variability suggests that the meropenem manufacturing process may have operated outside of a state of process control.
• Further investigation into manufacturing controls is warranted to ensure consistent meropenem quality.