Impurities and Foreign Matter | Analysis of Colored Components on the Surface of Pills (FTIR)

Impurities and Foreign Matter

Analysis of Colored Components on the Surface of Pills (FTIR)

Discoloration of the surface of pills may result from discoloration of pill components or the ingress of coloring components.
Parts of a pill surface discolored yellow (Fig. 1) were analyzed.
Fig. 1 shows that the discoloration seems to penetrate into the pill surface. As the surface is uneven, direct measurement by the FTIR microscope ATR method is difficult because it requires close contact. Therefore, the sample was prepared by scraping off the discolored area and analyzed by IR transmission microscopy.

Fig. 1 Photograph of Foreign Matter on Pill Surface

The foreign matter was scraped off, spread thinly over a diamond cell, and measured by IR transmission microscopy. Fig. 2 shows a magnified photograph and the spectrum of the sample spread on the diamond cell. The measured area was 30  30 microns.
A spectrum search predicted the colored component on the pill to be carnauba wax.
(Carnauba wax is a natural wax commonly used in lipstick, foundation, and food additives.)

Fig. 2 Photomicrograph and Spectrum of Colored Component Obtained by Infrared Microscope

Infrared Microscope System

The two major applications of IR analysis are foreign matter analysis and verification testing. Shimadzu offers two systems: IRPrestige-21, which features high sensitivity, high performance, and easy operation; and the general-purpose, easy-to-use IRAffinity-1.
The supplied high-security IRsolution software supports FDA 21 CFR Part 11. JP/EP/ASTM-compliant validation software and automatic recognition of attached accessories are also supplied as standard.
Functionality is significantly enhanced by incorporating as standard a foreign matter analysis program, which provides powerful support for the analysis of foreign matter, and a Japanese Pharmacopoeia support program that was previously offered as an option.