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How to Mitigate Disproportionation of API Salts in Pharmaceutical Formulations

Salt formation improves solubility and bioavailability for ionizable APIs, but disproportionation poses a significant stability risk. This white paper discusses key factors influencing disproportionation—such as pKₐ, pHₘₐₓ, and moisture—and presents practical strategies for risk mitigation through rational salt selection, excipient control, and formulation design. Case studies illustrate how these principles are applied in development.


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Small Molecule
Mol2Med™ Integrated Services Developability Assessment API Form and Solid-State Research Crystallization Development Services Pre-formulation Studies Formulation and Analytical Development GMP Manufacturing Clinical Supply
Crystal Bio Solutions
Biologics CMC Analytical Services Bioanalytical and Biomarker Services Quantitative Clinical Pharmacology (QCP)
Technology
Quick Links
About Us Events
NJ Sites: Suite 500-B, 3000 Eastpark Blvd, Cranbury, New Jersey, USA 08512
2005 Eastpark Blvd, Cranbury, New Jersey, USA 08512
CA Site: 7133 Koll Center Parkway, Suite 200, Pleasanton, California, USA 94566
bd_global@crystalpharmatech.com +1-609-604-8303
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