Development a Stability of Chloral hydrate in Extemporaneously Compounded Oral Suspension System

This study was conducted to find out the stability of Chloral hydrate 100 mg/ml in the X-Temp® solution oral suspension system. Various parameters such as physical, chemical and microbiological tests were studied. Physical properties such as pH, specific gravity and visual inspection were carried out at different intervals of 1, 15, 30, 60, 90 and 120 days. Microbiological tests for various organisms such as Pseudomonas, Staphylococcus aureus, Salmonella, E.Coli, Yeast and moulds were studied. In addition, assay was carried out using HPLC to compare the chloral hydrate sample with the standard drug. The Chloral hydrate suspension was stored for 120 days at two different temperatures such as 5°C and 30°C using refrigerator and stability chamber respectively. The samples were unchanged or had negligible change in the colour, odour, pH, specific gravity. Over a span of 120 days, there was no microbial growth observed, no alterations in physical attributes, and the assays met the required standards.