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Foreign matter identification from solid dosage forms.

Jari Pajander¹, Kenneth Brian Haugshøj, Kathrine Bjørneboe

¹Department of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.

Journal of Pharmaceutical and Biomedical Analysis

|April 4, 2013

Summary

Identifying foreign matter in pharmaceuticals is crucial for quality control. This study presents an efficient multi-technique analytical procedure for identifying diverse contaminants in drug products, ensuring manufacturing integrity.

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Area of Science:

Pharmaceutical Manufacturing
Analytical Chemistry
Materials Science

Background:

Pharmaceutical quality systems aim to prevent defects, but unidentified foreign matter can still compromise final products.
Identifying the source and nature of foreign matter is essential to prevent contamination but can be challenging due to diverse origins.

Purpose of the Study:

To develop an efficient procedure for identifying various foreign substances potentially originating from the pharmaceutical manufacturing environment.
To evaluate the effectiveness of a combination of analytical techniques for foreign matter identification in tablets.

Main Methods:

Analysis of uncoated and coated tablets using light microscopy (LM).
Scanning electron microscopy (SEM) coupled with energy-dispersive X-ray microanalysis (EDX).
Fourier transform infrared spectroscopy (FT-IR) and time-of-flight secondary ion mass spectrometry (ToF-SIMS).

Main Results:

A combined approach using multiple analytical techniques proved powerful for foreign matter identification.
LM and SEM provided morphological information on foreign particles.
EDX confirmed elemental composition, FT-IR identified chemical structure, and ToF-SIMS offered high sensitivity for widespread contamination.

Conclusions:

The integrated analytical strategy effectively identifies foreign matter in pharmaceutical products.
Combining microscopy, spectroscopy, and mass spectrometry enhances the ability to detect and characterize contaminants.
This procedure supports robust quality control in pharmaceutical manufacturing by enabling precise foreign matter analysis.