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Stability of Two Concentrations of Heparin Sodium Prefilled in CADD-Micro* Pump Syringes

M L Stiles1, L V Allen, H J McLaury

  • 1Quality Assurance Consultant.

International Journal of Pharmaceutical Compounding
|August 31, 2013
PubMed

The purpose of this study was to determine the stability of two concentrations (1000 units/mL and 40,000 units/mL) of heparin sodium when individually prefilled in CADD-Micro pump syringes (Sims Deltec, Inc., St Paul MN) and stored at near-body (30 deg C) temperature for extended periods of time, up to 30 days. Three syringes were prepared for each sample period and each concentration. Following aseptic filling, the syringes were capped and stored under controlled temperatures for the duration of the study. The contents of each of three syringes per sample set were expelled individually into screw-cap, glass sample vials at designated sample times. Samples were immediately stored at -70 deg C until the time of analysis. The results of the study indicate that, when prefilled in CADD-Micro pump polypropylene syringes and maintained at 30 deg C for up to 30 days, both concentrations of heparin sodium studied retained greater thatn 95% of the intact drug.

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