Date of Award

12-2012

Degree Name

Master of Science

Department

Chemistry

First Advisor

Dr. Andre R. Venter

Second Advisor

Dr. John Miller

Third Advisor

Dr. Sherine O. Obare

Access Setting

Masters Thesis-Campus Only

Restricted to Campus until

12-15-2022

Abstract

Ion mobility spectrometry (IMS) instrumentation has been identified as a suitable technology for the detection and reporting of drug product and detergent residues from pharmaceutical manufacturing equipment. Ion mobility is not a new technology, but is entering the field of cleaning validation because of tightened requirements from the US Food and Drug Administration (FDA).

The purpose of this thesis is to outline a practical implementation of the analytical technique, Ion Mobility Spectrometry in a cleaning validation program. Ion Mobility Spectrometry (IMS) is fast and specific for the analysis of small organic molecules and has been gaining popularity in the pharmaceutical industry. The challenge in the implementation of any new analytical technique in a pharmaceutical laboratory is establishing suitable methodology and this thesis will outline the steps taken for developing and validating a method for detection of the antihistamine drug Loratadine. The author will also provide a detailed introduction to the requirements of equipment qualification, cleaning validation and analytical method validation programs in the pharmaceutical industry.

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