The objective of this study is to look into the stability of Chloral Hydrate 40 mg per ml formulated as oral solution in X-temp Oral Suspension System in order to select proper storage conditions and establish beyond-use date. X-temp is a novel oral, flavoured sugar-free extemporaneous compounding vehicle to assist in the preparation of extemporaneous dosage forms. The compounded solution of 40 mg/ml was prepared by dissolving chloral hydrate powder in X-temp vehicle. The solution was then

more »

... d in amber HDPE containers, and were stored at refrigeration 5 ± 3°C and room temperature 30°C. Physical, chemical and microbiological parameters were evaluated at predetermined time-points up to 180 days. Samples were tested using a validated stability-indicating assay. Chloral hydrate concentration was assayed by high-performance liquid chromatography (HPLC). The stability results indicated that the solution remained unchanged in visual appearance or pH at both refrigeration and room temperature for up to 180 days. The HPLC results showed that all the stability studies maintained 90 -100% of initial drug concentration. There was no substantial changes in the microbiological stability. Chloral hydrate solution prepared in X-temp Oral Suspension System was stable for up to 180 days when stored at room temperature and refrigeration conditions. These results demonstrated that X-temp is a suitable vehicle for extemporaneous compounding for chloral hydrate.