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Variability was found in the drug pemetrexed (ALIMTA®) using spectroscopy. Some vials from different batches may contain different materials, impacting drug quality and patient treatment.

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Area of Science:

  • Pharmaceutical analysis
  • Drug quality control
  • Spectroscopy

Background:

  • Pemetrexed is a crucial antifolate drug for treating non-small cell lung cancer and mesothelioma.
  • Ensuring consistent drug quality is vital for therapeutic efficacy and patient safety.

Purpose of the Study:

  • To investigate intra-lot and inter-lot variability in pemetrexed (ALIMTA®) drug product spectra.
  • To identify potential material differences within and between manufacturing batches.

Main Methods:

  • Utilized Fourier transform near-infrared spectrometry (FTNIR) for spectral analysis.
  • Applied multidimensional standard deviation (SD) and subcluster detection tests to identify outliers.
  • Analyzed spectra from multiple vials across various manufacturing lots.

Main Results:

  • Significant spectral variability was detected within a specific lot (S20I013A), with 8% of vials deviating.
  • Analysis of a larger spectral library revealed 9.5% of vials from 23 lots were outliers, indicating differing materials.
  • Outlier vials were statistically distant from the main spectral groups.

Conclusions:

  • FTNIR spectroscopy identified significant variability in pemetrexed drug product quality.
  • A notable percentage of vials across multiple lots may contain different materials than expected.
  • These findings highlight potential challenges in maintaining consistent drug quality for pemetrexed.