Danielson J W
Food and Drug Administration, Sterility Analysis Research Center, Minneapolis, MN 55401.
J Assoc Off Anal Chem. 1991 May-Jun;74(3):476-8.
A capillary gas chromatographic method is described for the determination of cyclohexanone and 2-ethyl-1-hexanol leached from solution administration sets. A preliminary study was made of compounds leached from solution administration sets by 5% sodium bicarbonate solution (pH 8.1), 0.9% sodium chloride solution (pH 6.8), and water. Water was selected as the leaching solvent because similar quantities of the compounds were leached into water and into both types of parenteral solutions. The correlation coefficients were 0.99977 for cyclohexanone and 0.99974 for 2-ethyl-1-hexanol, and recoveries were good (93-94%). Five administration sets from each of 2 manufacturers were analyzed by this method. The amounts of cyclohexanone that were leached from the individual sets varied considerably; however, similar quantities were leached from sets of both manufacturers. 2-Ethyl-1-hexanol was also found in extracts from each of the sets analyzed.
本文描述了一种毛细管气相色谱法，用于测定从输液器中浸出的环己酮和2-乙基-1-己醇。对5%碳酸氢钠溶液（pH 8.1）、0.9%氯化钠溶液（pH 6.8）和水从输液器中浸出的化合物进行了初步研究。选择水作为浸提溶剂，因为类似量的化合物被浸提到水中以及两种类型的肠胃外溶液中。环己酮的相关系数为0.99977，2-乙基-1-己醇的相关系数为0.99974，回收率良好（93-94%）。用该方法分析了来自2个制造商的每个制造商的5个输液器。从各个输液器中浸出的环己酮量差异很大；然而，来自两个制造商的输液器浸出的量相似。在分析的每个输液器的提取物中也发现了2-乙基-1-己醇。
