Date of Award

1999

Degree Type

Thesis

Degree Name

Master of Science in Pharmaceutical Sciences

Specialization

Pharmaceutics

Department

Pharmaceutical Sciences

First Advisor

Christopher T. Rhodes

Abstract

The United States Pharmacopeia I National Formulary (USP/NF) sets the standards and maintains monographs for the evaluation of various dosage forms, especially during the storage and distribution channels. This document is compiled with the critical review of the stability testing of pharmaceutical products. In particular, it considers the progress toward globalization and harmonization, attention being directed to monitoring stability in the distribution channels. It is also focussed on the implications of Mean Kinetic Tempearature (MKT) concept and the effect of temperature spikes on MKT values, thus effecting the stability of drug products. The assignment of conformance period to the tablets were determined using the NIR stability indicating assay, both with the original data and the normalized. The stability of compounded cefazolin ophthalmic solution was studied for the various Arrhenius parameters and Beyond-use date assignment.

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