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

Author(s):  Stiles M Lou, Allen Loyd A Jr, McLaury Hei-Jen

Issue:  Nov/Dec 1997 - Diverse Ambulatory Patients
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Abstract:  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°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°C until the time of analysis.

The results of the study indicate that, when prefilled in the CADD-Micro pump polypropylene syringes and maintained at 30°C for up to 30 days, both concentrations of heparin sodium studied retained greater than 95% of the intact drug.

Related Categories: PEER-REVIEWED, STABILITIES, COMPATIBILITIES

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