Abstract

The purpose of this study was to determine the stability of aminocaproic acid 10 and 100 mg/mL admixed in 5% dextrose injection and 0.9% sodium chloride injection in polyvinyl chloride bags over periods up to seven days at 4° and 23°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 particle 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° C. This discoloration did not indicate substantial loss of aminocaproic acid. The HPLC evaluations found that an aminocaproic acid potency of at least 98% was retained throughout seven days in all solutions at both 4° and 23°C.

Related Keywords

• Aminocaproic acid injection, admixtures of
• Aminocaproic acid injection, stability of during storage
• Aminocaproic acid injection, effect of temperature on during storage

Related Categories

• PEER-REVIEWED
• STABILITIES, COMPATIBILITIES