Stability of aminocaproic Acid injection admixtures in 5% dextrose injection and 0.9% sodium chloride injection

The purpose of this study was to determine that stability of aminocaproic acid 10 and 100mg/mL admixed in 5% dextrose injection and 0.9% sodiium cholride injection in polyvinyl chloride bags over periods up to seven days at 4 deg and 23 deg C. The aminocaproic acid 250-mg/mL injection was filtered and admixed in filtered 5% dextrose injection and 0.9% sodium chloride injection to yield nominal aminocaproic acid concentrations of 10 and 100 mg/mL. Evaluations were performed initially and after one, three, and seven days of storage for physical and chemical stability. The admixtures were evaluated for physical stability using visual observation in normal fluorescent room light and a high-intensity monodirectional light beam, as well as electronic measurement of turbidity and particcle content. The chemical stability was evaluated by using a stability-indicating high performance liquid chromatography (HPLC) analytical technique. Aminocaproic acid admixtures were clear and colorless. However, the admixtures in 5% dextrose injection developed a slight yellowish discoloration after 24 hours at 23 deg C. This discoloration did not indicate substantial loss of aminocaproic acid. The HPLC evalurations found that an aminocaporic acid otency of at least 98% was retained throughout seven days in all solutions at both 4 deg and 23 deg C.