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Paper Details

Evaluation of Stability Study of Laxative Ayurvedic Formulation Constac Plus Granulation

Priyanka Jagtap, Akash Mohanrao More and Bhushan Bhagwat Kulkarni

Journal Title:International Journal of Ayurveda and Pharmaceutical Chemistry
Abstract


The aim 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. The present study was conducted to evaluate accelerated stability (Temperature: 40 °C ± 2, Relative Humidity (RH): 75% ± 5) and real time stability (Temperature: 25 °C ± 2, Relative Humidity (RH): 60% ± 5) of Constac plus granulation. A study was conducted as per ICH guideline Q1A (R2). The variation in the organoleptic, physico-chemical and microbial load constants of the Constac plus granulation (fine granulation) was observed during 0 (initial), 1, 3 and 6 months. Results of different physico-chemical parameters were taken into consideration to evaluate intercept and slope. Study shows that there was no change in color, odour and taste of Constac plus granulation up to storage of 6 months at accelerated condition. Formulation was suitable at accelerated condition up to 6months storage. It can be extrapolated that shelf life of Constac plus granulation is 26.54 months. The real time stability data of Constac plus granulation showed very good stability up to one year.

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