Ethylene Glycol in Hydroxyethyl Starch According to EP

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The impurity analysis of ethylene glycol in hydroxyethyl starch (HES) was evaluated using the exact method and conditions described in the official EP 8.2 (2014) monograph [2]. The evaluation was performed using an ALEXYS® LC-EC analyzer for ethylene glycol, based on the DECADE Elite electrochemical detector and a SenCell with Au working electrode (WE) and HyREF (Pd/H 2 ) reference electrode. Detection of ethylene glycol was achieved by post-column addition of 250 mM NaOH followed by Pulsed Amperometric Detection (PAD) using a 4 step potential waveform. In this application note typical results obtained with the ALEXYS analyzer are reported, demonstrating its performance for the impurity analysis of ethylene glycol in HES bulk material used in blood volume expanders. n European Pharmacopoeia 8.2 (2014) n Impurity analysis n Reproducible and robust The most reliable LC-EC applications for Drugs & Pharmaceuticals analysis

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تاریخ انتشار 2017