Der Pharma Chemica
Journal for Medicinal Chemistry, Pharmaceutical Chemistry and Computational Chemistry

Abstract

Comparative stability study of formulated ayurvedic health supplement and marketed product

Author(s): Deepa P and N Kannappan

The purpose of the stability testing is to provide proof of how the quality of a finished product varies with time under the influence of a variety of environmental factors such as temperature, humidity and light. Different parameters like moisture content, pH, total ash, crude fiber, acid in soluble ash, total microbial count were checked at regular intervals [6] . These studies are conducted at 25°C ± 2°C/ 60 % RH ± 5 % RH and 40 °C±2°C /75 % ± 5% RH noted for significant changes occurs at any time during one year. If any significant change occurs at any time during six months, testing at the accelerated storage condition, and additional testing at the intermediate storage condition should be conducted and evaluated against significant change criteria. In our study no intermediate storage condition should be included because no significant changes occur between three and six months. In this the newly formulated health supplement under gone long term testing over a minimum of 12 months and marketed product was compared for the following parameters at specified conditions. Organoleptic, chemical, biological and microbiological characteristics of a finished product, during and beyond the expected shelf life and storage periods of the sample under the storage conditions expected in the intended market are determined with the help of stability studies[4]. These results helped to establish the re-test period or shelf life, to confirm the projected re-test period and shelf life, and pave a way to recommend a storage condition. Stability testing of pharmaceutical products is a complex set of procedures involving considerable cost, time consumption and scientific expertise in order to build in quality, efficacy and safety in a drug formulation. . If any considerable changes are noticed in one or more properties of the formulation, with in the time limit, it results inefficacy problem


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