Pharmaceutical compositions comprising ferric citrate for reducing serum phosphate levels, and use thereof for the preparation of medicaments for treating or ameliorating calcium-associated disorders

摘要

The present invention discloses a pharmaceutical-grade ferric organic compounds, including ferric citrate, which are soluble over a wider range of pH, and which have a large active surface area. A manufacturing and quality control process for making a pharmaceutical -grade ferric citrate that consistently complies with the established Manufacture Release Specification is also disclosed. The pharmaceutical-grade ferric organic compounds are suitable for treating disorders characterized by elevated serum phosphate levels.