Disproportionation of a crystalline citrate salt of a developmental pharmaceutical compound: Characterization of the kinetics using pH monitoring and online Raman spectroscopy plus quantitation of the crystalline free base form in binary physical mixtures using FT-Raman, XRPD and DSC

Author:

Skrdla Peter J.,Zhang Dan

Publisher

Elsevier BV

Subject

Clinical Biochemistry,Spectroscopy,Drug Discovery,Pharmaceutical Science,Analytical Chemistry

Reference15 articles.

1. Phase transformation considerations during process development and manufacture of solid oral dosage forms;Zhang;Adv. Drug Deliv. Rev.,2004

2. Salt formation to improve drug solubility;Serajuddin;Adv. Drug Deliv. Rev.,2007

3. Implementing quality by design in pharmaceutical salt selection: a modeling approach to understanding disproportionation;Merritt;Pharm. Res.,2013

4. Role of salt and excipient properties on disproportionation in the solid-state;Guerrieri;Pharm. Res.,2009

5. Physical stability of salts of weak bases in the solid-state;Stephenson;J. Pharm. Sci.,2011

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