Analytical method for the determination of the nature of distilled water used for drug analysis

Abstract

Water is widely used as a raw material, ingredient and solvent in the processing, formulation & manufacture of API’s, intermediates, analytical reagents and pharmaceutical products. Objective of the present study is to ensure that the water system is under control limits and continues to produce water of an acceptable quality. For the estimation of control &quality limits the parameters such as alkalinity, acidity, pH, hardness, turbidity, tempera- ture, aluminum, sodium, and potassium were determined by following the specified methods. The alkalinity, acidi- ty nature was not detected in the sample, pH - 6.8, hardness- 4.8, turbidity- 0.1NTU, aluminum - 1.5mg/ml sodium & potassium - 0.5mg/ml temperature - 21oC TDS was not detected in the sample. The results of all developed me- thods meet the acceptance criteria as per the standards specified in FDA standards of quality. Thus, suggesting these methods of determination was simple and suitable for the determination of various parameters of distilled water used for drug analysis.