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Analytical Light Microscopy: Examples of Practical Problemsolving and Efficiency in Pharmaceutical Quality Control and Formulation

Published online by Cambridge University Press:  02 July 2020

D. A. Stoney  and
W. C. McCrone
D. A. Stoney
Affiliation:
McCrone Research Institute, 2820 S. Michigan Ave., Chicago, IL, 60616.
W. C. McCrone
Affiliation:
McCrone Research Institute, 2820 S. Michigan Ave., Chicago, IL, 60616.
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Extract

Five applications of analytical light microscopy to problem-solving in the pharmaceutical industry are described and illustrated by case examples. Problems included are (1) the caking of pharmaceutical products, (2) chemical incompatibility, (3) nucleation and precipitation, (4) recognition of hydrates and polymorphs, and (5) identification and sourcing of contaminant particles.

Considerable effort goes into the sizing of solid pharmaceutical raw materials and products. In many instances, particle size is used to help control the rate and uniformity of dissolution, which in turn affects the kinetics of drug delivery. Caking is a macroscopic description of the change in a sample from a finely-divided powder to a single solid molded aggregate. Caking obviously has a severe impact on handling and dissolution characteristics.

Caking of a powder is almost always caused by moisture through the cyclical dissolution and precipitation on the surfaces of the particles. When exposed to sufficient vapor pressure, often through changes in humidity or temperature,

Type
Microscopy and Microanalysis in the “Real World”
Information
Microscopy and Microanalysis , Volume 4 , Issue S2: Proceedings: Microscopy & Microanalysis '98, Microscopy Society of America 56th Annual Meeting, Microbeam Analysis Society 32nd Annual Meeting, Atlanta, Georgia July 12-16, 1998 , July 1998 , pp. 474 - 475
Copyright
Copyright © Microscopy Society of America

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References

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