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Common Tablet Problems

Pharmaceutical products are usually submitted for analysis because they have failed either a visual inspection or have high particle counts (HIAC). Although the analysis of the unknown is usually straightforward, the challenge is in locating, visualizing and isolating the extraneous material.

In many cases the extraneous material is some type of silicone which presents itself in a variety of forms, both in solution and upon isolation. It most commonly appears in three forms: (1) as bubbles which tend to linger in solution longer than air bubbles; (2) as small amorphous, flake-like, colorless to “water-white” particles; and (3) as long, stringy, colorless particles that may mimic fibers.

As the silicone particles are not rigid, they can easily pass through even the smallest pore-size filter. Therefore, the silicone particles must be filtered through special, thin filters. Even then, filtration will not remove all of the silicone. Coaxial illumination is then used to locate the silicone particles on the filter.

This is just one example of the microanalytical services McCrone provides to the pharmaceutical industry.