Compatibility of chlordiazepoxide HCL injection following dilution

The compatibility and stability of chlordiazepoxide HCl injection were studied following dilution to concentrations of 1 mg/ml and 2 mg/ml with dextrose 5% in water, 0.9% sodium chloride, and Ringer's injection. Solutions were prepared both in glass containers and plastic iv bags and stored at 22° for 4 hr. Prepared solutions were examined visually and microscopically for clarity throughout the 4-hr period and for pH initially and at 4 hr after preparation. Clear solutions were assayed using UV spectrophotometry. Acceptable potency was regarded as ≥90% of initial concentration. The concentrations of hydrolytic breakdown products of chlordiazepoxide were determined by direct UV spectrophotometric scanning of TLC plates. No visual incompatibilities were observed during the 4-hr study period and the pH of the dilutions remained constant. Chordiazepoxide was found to be stable (≥90% initial concentration) in the 3 iv fluids at both concentrations when stored in glass for 4 hr. Acceptable potency was maintained for 4 hr in dextrose 5% in water and Ringer's injection in plastic iv bags. Acceptable potency for 1 mg/ml chlordiazepoxide in 0.9% sodium chloride was maintained only for 2 hr and for the 2 mg/ml concentration for 30 min in plastic iv bags. The concentrations of hydrolytic breakdown products of clordiazepoxide were within the specified USP limits. It appears that sorption of chlordiazepoxide to plastic iv bags is occurring and this interaction is dependent on time and the type of iv fluid.