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Stability of Dalteparin 1,000 Unit/mL in 0.9% Sodium Chloride for Injection in Polypropylene Syringes
Kylian Kirkham1, Jessica M Munson2, Susan V McCluskey3
1Mayo Clinic Rochester, Rochester, Minnesota. kirkham.kylian@mayo.edu.
International Journal of Pharmaceutical Compounding
|December 8, 2017
Summary
Dalteparin sodium 1,000 units/mL in 0.9% sodium chloride for injection remained stable for 30 days when refrigerated in polypropylene syringes. This finding supports the extended shelf-life of compounded dalteparin preparations.
Area of Science:
- Pharmaceutical Sciences
- Drug Stability Studies
- Compounded Medications
Background:
- Dalteparin sodium is a low molecular weight heparin used for anticoagulation.
- The stability of compounded drug formulations is crucial for patient safety and therapeutic efficacy.
- Understanding the stability of dalteparin in pre-filled syringes is essential for clinical practice.
Purpose of the Study:
- To evaluate the stability of dalteparin 1,000 units/mL in 0.9% sodium chloride for injection.
- To determine the stability of dalteparin when stored in polypropylene syringes under refrigeration.
- To assess the impact of storage conditions on dalteparin potency, appearance, and pH over 30 days.
Main Methods:
- Dalteparin 1,000 units/mL solutions were prepared by diluting commercial dalteparin sodium 10,000 unit/mL with 0.9% sodium chloride for injection.
- Compounded solutions were transferred to 1-mL polypropylene syringes and stored at 2°C to 8°C with ambient light exposure.
- Stability was assessed using a stability-indicating high-performance liquid chromatography (HPLC) assay for potency, visual inspection for clarity and particulates, and pH measurements at specified intervals over 30 days.
Main Results:
- HPLC analysis demonstrated that dalteparin retained 94.88% ± 2.11% of its initial content after 30 days.
- Visual inspection revealed no changes in color, clarity, or particulate matter, and no container compromise.
- pH values remained stable, fluctuating within 0.3 pH units of the initial value (5.84) throughout the study.
Conclusions:
- Dalteparin 1,000 units/mL in 0.9% sodium chloride for injection is stable for at least 30 days when stored in 1-mL polypropylene syringes under refrigeration.
- The findings support the use of these compounded syringes for clinical applications within the established stability period.
- This study provides valuable data for pharmacists and healthcare providers regarding the storage and handling of refrigerated dalteparin preparations.
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