44 Mineralogy, Igneous, Metamorphic Petrology, Volcanology

Tuesday, 20 March 2012
8:00 AM - 12:00 PM
Ballroom E

MINERALOGY IN THE PHARMACEUTICAL INDUSTRY

Paper number: 44-12
Program: Technical Sessions
Time: 11:40 AM – 12:00 PM

Authors

  • John A. Smoliga Presenting Author
    Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, CT

Abstract

Well over 30 minerals from both natural and synthetic sources are utilized within the pharmaceutical industry for various purposes. These include active pharmaceutical ingredients (API's), excipients (non-active ingredients), and coloring agents along with fillers used in polymeric packaging materials.

The FDA requires that these minerals be controlled for quality and purity. As is typical in mineralogical laboratories, characterization and analyses of these minerals are conducted using polarized light microscopy, scanning electron microscopy, energy dispersive x-ray fluorescence spectroscopy, x-ray powder diffraction, Fourier transform infrared spectroscopy and Raman spectroscopy. This paper will review minerals used in the pharmaceutical industry; there specific function along with the methods for characterization and control. Additionally some comparisons of the physical properties of synthetic vs. naturally occurring minerals used in pharmaceuticals will be presented.