Excipients containing low residual solvent and method for producing the same

摘要

The present invention provides low-residual-solvent containing excipients with residual solvent less than <3000 ppm. Most of the excipients are required to first be modified to become more water absorbing such as by attaching a water absorbing radical, e.g., (-CH₂COONa) to the carbinol groups (-CH₂OH) of the excipients to form a -CH₂-O-CH₂COONa linkage. The linkage of the water-absorbing groups to e excipients improves the water absorbing property of the excipients, which facilitates the replacing residual solvent with water. The residual solvent can be extracted from the excipient by way of mixing with a solvent/water solution containing (1) about 75-95% (v/v) isopropanol and about 5-25% water (v/v); (2) about 65-95% acetone and about 5-35% water; and (3) about 60-85% methanol and about 15-40% water.