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This procedure is generally performed to remove excess fumaric acid based on it's low solubility in water and to remove residual solvent by dispersing it and allowing it to evaporate more easily and completely. The resulting product is considered to be the most appropriately purified form for oral administration.
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- Add a small amount of water in slight excess of completely submerging the product.
- Stir mixture to dissolve the active fumarate component.
- Decant solution off, leaving solids behind.
- Repeat process until no more color change is observed in the solution, but perform once more with a minimal amount of water for good measure.
- the solids remaining should be mainly composed of the excess fumaric acid from the starting material.
- Evaporate the solution with or without heat and airflow to achieve purified crystalline fumarate product.
- reduction of the solution by heat and airflow is generally always beneficial, but slow evaporation in the later stages may result in a more uniform and attractive crystalline product.
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