Compatibility and activity of enoxaparin sodium in 0.9% sodium chloride injection for 48 hours.
The stability of enoxaparin sodium in 0.9% sodium chloride injection in polyvinyl chloride (PVC) containers was studied. Triplicate solutions of 120 mg (1.2 mL) of enoxaparin (as the sodium salt) and 98.8 mL of 0.9% sodium chloride injection were prepared in 250-mL PVC containers and stored at room temperature (20-22 degrees C). Samples were taken immediately after preparation and at 0.25, 0.5, 0.75, 1, 4, 12, 16, 24, and 48 hours. Inspections for color change and precipitation were performed with a clarity inspection station and a magnifying glass. Samples of the three admixtures were evaluated in duplicate for pharmacologic activity by an automated coagulation heparin assay. Throughout the 48-hour study period, the enoxaparin admixtures were free of color change, evolution of gas, and precipitates. The pharmacologic activity of enoxaparin in the PVC containers remained > 94% of the initial measured activity for 48 hours. Enoxaparin 1.2 mg/mL (as the sodium salt) in 0.9% sodium chloride injection in PVC containers was stable for up to 48 hours at 20-22 degrees C.
Mewborn
A L
AL
School of Pharmacy, University of North Carolina (UNC), Chapel Hill, USA.
Kessler
J M
JM
Joyner
K A
KA
D000925:Anticoagulants / Q000008:administration & dosage / Q000737:chemistry* / Q000494:pharmacology*; D002626:Chemistry, Pharmaceutical; D004349:Drug Packaging; D004355:Drug Stability; D017984:Enoxaparin / Q000008:administration & dosage / Q000737:chemistry* / Q000494:pharmacology*; D011143:Polyvinyl Chloride; D012965:Sodium Chloride / Q000737:chemistry*; D013997:Time Factors
D000925:Anticoagulants; D017984:Enoxaparin; D012965:Sodium Chloride; D011143:Polyvinyl Chloride