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Assessment of Physicochemical Parameters of Tubing's of Intravenous Infusion sets

Author Affiliations

  • 1 Department of Chemistry, Faculty of Applied Sciences, Integral University, Lucknow, INDIA
  • 2 Analytical Chemistry Division, Indian Institute of Toxicology Research, M.G. Marg, Lucknow, INDIA

Res. J. of Pharmaceutical Sci., Volume 1, Issue (4), Pages 1-9, December,30 (2012)

Abstract

The main objectives of study were to evaluate the physicochemical test of the leachates of Intravenous infusion sets of seven brands used in thepresent study were purchased from different medical shops in Lucknow. At 60±2°C for 2 hours condition, the maximum global migration residue was found from IV-6 sample in 5% sodium carbonate (6.2 mg/100 ml) while the minimum was in IV-5 sample in 3% acetic acid (0.2 mg/100 ml) (Fig.1). The results also showed that at 25±2°C for 24 hours condition, the maximum global migration residue was found from IV-6 sample in 0.9% sodium chloride (5.2 mg/100 ml) while the minimum was in IV-5 sample in 3% acetic acid (0.14 mg/100 ml) (Fig.2). The results revealed that at 60±2°C for 2 hours condition, the maximum migration of oxidizable matters was from the leachates of IV-3 sample in double distilled water (3 ml; difference in the volume of sodium thiosulphate consumed) while the minimum migration of oxidizable matters was observed in IV-4 and IV-5 sample in sodium carbonate (0.1 ml) (Fig 3). At 25±2°C for 24 hours condition, the maximum migration of oxidizable matters was from the leachates of IV-3 sample in double distilled water (2.3 ml; difference in the volume of sodium thiosulphate consumed) while the minimum migration of oxidizable matters was observed in IV-2, IV-4, IV-5 and IV-7 sample in sodium carbonate (Fig. 4). At 60±2°C for 2 hours condition, the maximum migration of UV absorbing materials was from IV-1 sample in 0.3% acetic acid (OD – 0.206) whiles the minimum was from IV-5 sample in 0.9% sodium chloride (OD – 0.035). The migration was below the permissible limit (OD – 0.3) (Fig. 5). At 25±2°C for 24 hours condition, the maximum migration of UV absorbing materials was from IV-1 sample in 0.3% acetic acid (OD – 0.161) whiles the minimum was from IV-5 sample in 0.9% sodium chloride (OD – 0.031). The migration was below the permissible limit (OD – 0.3) (Fig. 6). The results showed that the leaching of additives used in plastic biomedical devices is temperature dependent i.e. high at higher temperature. These additives are not chemically bound to the matrix of the polymeric materials and leach out during normal use.

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