Determination of Tobramycin in Crude and In-Process Production Samples During Manufacturing Using HPAE-IPAD
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Identification of tobramycin impurities for quality control process monitoring using high-performance anion-exchange chromatography with integrated pulsed amperometric detection.
Commercial-scale fermentation for tobramycin manufacture is carried out with Streptomyces tenebrarius. Impurity profiling during various phases of pharmaceutical production is important for evaluating the effectiveness of a processing step and meeting regulatory requirements. High-performance anion-exchange (HPAE) chromatography with integrated pulsed amperometric detection (HPAE-IPAD) is a hig...
متن کاملDetermination of Tobramycin and Impurities Using HPAE-PAD
INTRODUCTION Tobramycin is a water-soluble aminoglycoside antibiotic used in a variety of pharmaceutical applications, including ophthalmic and intravenous administrations. Tobramycin is purified from the fermentation of the actinomycete Streptomyces tenebrarius. Kanamycin B (also known as bekanamycin), nebramine, and neamine (also known as neomycin A) are three known impurities of tobramycin, ...
متن کاملDetermination of Tobramycin and Impurities Using HPAE-PAD
INTRODUCTION Tobramycin is a water-soluble aminoglycoside antibiotic used in a variety of pharmaceutical applications, including ophthalmic and intravenous administrations. Tobramycin is purified from the fermentation of the actinomycete Streptomyces tenebrarius. Kanamycin B (also known as bekanamycin), nebramine, and neamine (also known as neomycin A) are three known impurities of tobramycin, ...
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