院内製剤セレン注射薬の品質試験

概要

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Selenium injection for intravenous hyperalimentation was prepared and quality test was conducted on their content uniformity, pH, osmotic pressure, and pyrogen test. For the determination of selenium in injection, an yellow selenium-Bismuthiol II complex formed in hydrochloric acid solution was extracted quantitatively with chloroform and washed the chloroform extract with a buffer solution (pH 7.5) to remove the excess reagent from the organic phase. The measurement of absorption of the organic phase at 334nm was applied for the determination of small amounts of selenium. The mole ratio of selenium to Bismuthiol II was 1:4 by means of continuous variation method. This method is considered to be highly suitable for routine analysis. The standard contents of the element in the injections were determined in the range of 98 to 102%. The pH was decreased after the sterilization. Then, osmotic pressure of selenium injection was 2.20±0.45mOsm/ml. All samples were negative to pyrogen test (Limulus Lysate).
日本医療薬学会の論文
1988-10-20