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Stability of Dalteparin 1,000 Unit/mL in 0.9% Sodium Chloride for Injection in Polypropylene Syringes

Author(s):  Kirkham Kylian, Munson Jessica M, McCluskey Susan V, Graner Kevin K

Issue:  Sep/Oct 2017 - Volume 21, Number 5
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Abstract:  The stability of dalteparin 1,000 units/mL in 0.9% sodium chloride for injection stored in polypropylene syringes under refrigeration was examined. Dalteparin 1,000-units/mL syringes were prepared by adding 9 mL of 0.9% sodium chloride for injection to 1 mL of dalteparin sodium 10,000 unit/mL from commercial single-use syringes. Compounded solutions in 0.5-mL aliquots were transferred to 1-mL polypropylene syringes and sealed with a Luer lock tip cap and stored at refrigerated temperatures (2°C to 8°C) with ambient fluorescent light exposure. Syringes from three batches of dalteparin 1,000 units/mL were potency tested in duplicate by a stability-indicating high-performance liquid chromatography assay using a 0.5-mL sample at specified intervals. Visual and pH testing were performed on each batch. Samples were visually inspected for container integrity, color, and clarity. Samples for pH testing were prepared using a 1:1 dilution of dalteparin 1,000 units/mL in sterile water for injection and underwent duplicate analysis at each time point. High-performance liquid chromatography analyses showed a remaining percent of the initial dalteparin content at day 30 of 94.88% ± 2.11%. Samples remained colorless and clear with no signs of container compromise and no visual particulate matter at each time point. Throughout the 30-day study period, pH values remained within 0.3-pH units from the initial value of 5.84. Dalteparin 1,000 unit/mL in 0.9% sodium chloride for injection, packaged in 1-mL polypropylene syringes was stable for at least 30 days while stored at refrigerated conditions with ambient fluorescent light exposure.

Related Keywords: Kylian Kirkham, PharmD, Jessica M. Munson, MS, Susan V. McCluskey, BS Pharm, Kevin K. Graner, BS Pharm, dalteparin, low molecular weight heparin, LMWH, venous thromboembolism, deep vein thrombosis, thrombotic disorders, blood clot, children, chemical stability

Related Categories: PACKAGING, PEDIATRICS, PEER-REVIEWED, STABILITIES, COMPATIBILITIES, STERILE PREPARATIONS, HEMOSTASIS, BLEEDING, ANTICOAGULATION

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