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pH Stability of Injectable Fentanyl, Bupivacaine, or Clonidine Solution or a Ternary Mixture in 0.9% Sodium Chloride in Two Types of Polypropylene Syringes

Author(s):  Jappinen Annaliisa L, Kokki H, Rasi A S, Naaranlahti Toivo J

Issue:  Nov/Dec 2002 - Sterile Preparations and Pediatric Compounding
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Abstract:  The pH stability of injectable fentanyl, bupivacaine, or clonidine solution or a ternary mixture in 0.9% sodium chloride, all of which were stored in polypropylene syringes, was determined. Two different types of polypropylene syringes were tested: one (Omnifix, B. Braun, Melsungen, Germany) had a synthetic latex-free polyisoprene piston and the other (Terumo, Leuven, Belgium) did not contain natural rubber or synthetic rubber.

Forty-eight Omnifix 50-mL syringes and 120 Terumo 20- mL syringes were tested. The syringes were filled with a fentanyl citrate solution 35 µg/mL (stored in 12 Omnifix and 30 Terumo syringes), a bupivacaine hydrochloride solution 1 mg/mL (12 Omnifix and 30 Terumo syringes), a clonidine hydrochloride solution 9 µg/mL (12 Omnifix and 30 Terumo syringes), or a ternary mixture in 0.9% sodium chloride (12 Omnifix and 30 Terumo syringes). The syringes were stored for 30 days at 4°C, 21°C, and 35°C. Duplicate samples were prepared, observed for precipitation and color change, and measured for pH immediately after preparation and at 1, 2, 5, 7, 9, 12, 16, 23, and 30 days of storage.

There was no color change or precipitation in any sample during 30 days of storage at any of the temperatures studied. There was no change in the pH of the fentanyl, bupivacaine, or clonidine solutions or in the ternary mixture stored in Terumo syringes for 30 days at 4°C, 21°C, and 35°C. Omnifix syringes performed differently with different drug solutions. No significant change in the pH of the fentanyl, bupivacaine, or clonidine solutions or of the ternary mixture stored in the Omnifix syringes was observed during 30 days of storage at 4°C, 21°C, and 35°C, except for the clonidine solution stored at 21°C and 35°C.

Related Keywords: Bupivacaine solution, pH stability of during storage, Clonidine solution, pH stability of during storage, Fentanyl, bupivacaine, and clonidine solution (ternary mixture), pH stability of during storage, Fentanyl solution, pH stability of during storage

Related Categories: PEER-REVIEWED, STABILITIES, COMPATIBILITIES

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