GAS-CHROMATOGRAPHIC MASS-SPECTROMETRIC DETECTION OF TRACE AMOUNTS OF ORGANIC-COMPOUNDS IN THE INTRAVENOUS SOLUTION INFUSIO-DARROWI

A gas chromatographic-mass spectrometric procedure was employed to confirm the presence of trace amounts of organic compounds in the intravenous solution Infusio Darrowi. Organic contaminants in the solution analysed were concentrated by microextraction with n-pentane. The main compounds detected were 2,6-di-tert.-butyl-4-methylphenol, 2.6-di-tert.-butyl-4-ethylphenol, 2,6-di-tert.-butyl-4-methoxyphenol, benzothiazole, isomeric C-9 alkyl phenols and di(n-butyl) phthalate. These impurities were leached from rubber stoppers during their sterilization into the intravenous solution at levels ranging ca. from 5 . 10(-6) to 5 . 10(-8) g/l.