AN181: Determination of Streptomycin and Impurities Using HPAE-PAD

Instrument Type: IC

Thermo Scientific Dionex ICS-3000 system with PAD is used to run the USP Compendial Method for the assay of streptomycin sulfate. Key performance parameters, including precision in determining streptomycin purity, limits of detection, linearity, and ruggedness, are shown to be consistent with normal method validation requirement. HPAE-PAD technology is demonstrated here for streptomycin A purity analysis and its feasibility for determinations in a fermentation broth. Finally, streptomycin A purity per the requirements of the ICH for new drug substances is evaluated.