Objective:

To evaluate the feasibility of near-infrared chemical imaging (NIR CI) as a process analytical tool for monitoring powder potency in pharmaceutical manufacturing.

Approach:

• Research Background: The research focuses on the shift from quality by testing to quality by design in pharmaceutical dosage form manufacturing.
• Technology Comparison: NIR CI is compared to existing near-infrared spectroscopy (NIRS) technology for feed frame monitoring.

Key Findings:

• NIR CI provides both spectral and spatial information, unlike NIRS which only offers spectral data.
• NIR CI performs comparably to NIRS in concentration monitoring and can probe local concentration variations.
• The larger sample area available with NIR CI enhances its potential as a robust process analytical technology.

Interpretation:

Limitations:

• NIRS has limitations in robustness and understanding as a PAT tool due to spectral baseline variations and variable probe locations.

Conclusion:

Sources:

• Himmat Dalvi Interview