Studies on Plastic Container for Aqueous Infusion

• Published in: YAKUGAKU ZASSHI Vol. 104; no. 5; pp. 472 - 478
• Main Authors: KIKUCHI, MINEO, MORITA, TAKESHI, HANEDA, MASATOSHI, ITOH, MASAO, OHBU, YUKO, USHIO, HIDETOSHI, KURIKI, YOKO, MITSUHASHI, KANAKO, KUBONIWA, HITOSHI, SUZUKI, YAYOI, SHIBA, MOTOHARU
• Format: Journal Article
• Language: Japanese
• Published: Japan The Pharmaceutical Society of Japan 25-05-1984
• Subjects: Drug Packaging; head space gas chromatography; Hot Temperature; plastic container; plastic container test; Plastics; polypropylene; polypropylene thermal degradation; Polypropylenes; Solubility; Solutions
• ISSN: 0031-6903; 1347-5231
• DOI: 10.1248/yakushi1947.104.5_472

In order to develop the aqueous infusion packed in a polypropylene (PP) container, the properties of the PP containers, packed with distilled water and a physiological saline, and then stored under several conditions, were examined concerning the following items. 1. Physicochemical properties of the container. 2. Components soluble in the liquid inside the container. 3. Components of the head space gas in the container. Under every storage condition, it was found that the pp container met the requirements of Plastic Container for Aqueous Infusion, General Test, Pharmacopoeia of Japan (JP) and any changes in the physicochemical properties were not observed. No aldehyde, ketone, and carbonyl compounds derived from the oxidative degradation of PP were detected in the inside liquids. The number of insoluble matters was not more than that in the regulation of Infusions, General Rules for Preparations, JP and did not increase at every storage conditions. The saturated and unsaturated hydrocarbons, of which the number of carbon was 4 to 7, having largest quantity among these hydrocarbons, turned out to be about 120 ppb. It is clarified that these hydrocarbons result from the partial pyrolysis of pp through the heat treatment of the container.