HPLC determination of rubber septum contaminants in the iodinated intravenous contrast agent (sodium iothalamate).
A simple and rapid method is described for the determination of 2-mercaptobenzothiazole and mercaptobenzothiazole disulfide leached from rubber closures into the iodinated contrast medium (sodium iothalamate). The contaminants were extracted with methylene chloride and analyzed by high-performance liquid chromatography using ultraviolet detection at wavelengths of 272 and 328 nm. The structures of the impurities were confirmed unequivocally by mass spectrometry. The minimum detectable level was 1 microgram/100 mL (0.01 ppm). The quantitation of contaminants leached from rubber stoppers provides a means for evaluating possible health risks of the extractables.
Gaind
V S
VS
Occupational Health Laboratory, Ontario Ministry of Labor, Weston, Canada.
Jedrzejczak
K
K
D052160:Benzothiazoles; D002851:Chromatography, High Pressure Liquid; D004340:Drug Contamination; D007483:Iothalamic Acid; D013058:Mass Spectrometry; D012408:Rubber; D013844:Thiazoles / Q000032:analysis*
D052160:Benzothiazoles; D013844:Thiazoles; D007483:Iothalamic Acid; C005563:captax; C028000:dibenzothiazyl disulfide; D012408:Rubber