Abstract

STABILITY AND COMPATIBILITY STUDY OF DEXTROSE 5% (D5) AND DEXTROSE 5% WITH SODIUM CHLORIDE (0.9%) (DNS) INJECTION IN DIFFERENT STORAGE CONDITION.

Debmalya Roy and Li Sun*

Abstract

The purpose of the stability study is to examine, how the quality of the Active Pharmaceutical Ingredients (API) and medicinal products vary with time under different factors, such as temperature, humidity, pH and light. On the basis of the stability study, shelf life, storage condition and re-test period are determined. We carried out stability study and process validation of D5 and DNS injection in first three consecutive batches and plotted graph by using data of pH and assay of dextrose, sodium and chloride. In this study, we found degradation of dextrose in D5 and DNS injection with increasing time. Both of this parenteral products were studied accelerated and real time, and dextrose was analyzed by polarimetry, and sodium chloride was analyzed by flame photometry and titration method, finally the data were evaluated statistically.

Keywords: Stability study, D5 and DNS, humidity, temperature, accelerated study, real time study.