| Cryogenic GC/MS Analysis of Offensive Gas Produced via Reconstitution of Freeze-Dried Clindamycin Phosphate |
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*a) Metabolite Research Laboratory, Daiichi Chemical Yakuhin (2117 Muramatsu, Tokaimura, Naka-gun, Ibaraki 319-1182, Japan) b) Glaxo Wellcome Tsukuba Research Laboratory (43 Wadai, Tsukubo, Ibaraki 300-4247, Japan) |
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| A cryogenic gas chromatography/mass spectrometry (GC/MS) was developed for the head space analysis of a reconstituted Dalacin P for Injection® containing clindamycin phosphate as the active entity, and this method improved retention time separation near mercaptan and enhanced detection sensitivity. A reconstituted Dalacin P® smells like a “rotten cabbage”. The cryo-GC/MS method found that ca. 100 ppm of methyl mercaptan and ca. 600 ppm of dimethyl disulfide are mainly produced as offensive materials. Contrary to this, in the headspace of the Dalacin S for Injection® (the new formulation) contained both materials less than 3 ppm. | ||
| Key words: Cryogenic gas chromatography/mass spectrometry, Clindamycin phosphate, Methyl mercaptan, Dimethyl disulfide, Oxidative dimerization | ||
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