Abstract
A new chiral chromatography method has been developed to determine the chiral purity of MB-102. This method employs exchange of counter ions with the MB-102 molecule. Chromatography conditions including column temperature and concentration of counter ions were evaluated and optimized. This method may be used to monitor process development during formulation manufacture, is amenable to large scale production, and is suitable for the determination of agent chirality for reporting in regulatory submissions. Manufactured clinical supplies of both the drug substance and the drug product using this technique have been shown to routinely yield 99.9+ % D, D enantiomer. This new method is shown to be precise, accurate, and robust.
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