Salts of dexlansoprazole and their preparation
The present invention relates to the salts of dexlansoprazole in amorphous form. The present invention further relates to processes for the preparation of salts of dexlansoprazole.
1. A process for the preparation of the sodium salt of dexlansoprazole in amorphous form, wherein the process comprises:
a) contacting dexlansoprazole with sodium hydroxide in the presence of water; and
b) isolating the sodium salt of dexlansoprazole in amorphous form from the mixture thereof.
2. The process according to the claim 1 , wherein the sodium salt of dexlansoprazole in amorphous form is further converted into crystalline dexlansoprazole.
3. Sodium salt of dexlansoprazole in amorphous form.
4. Sodium salt of dexlansoprazole in amorphous form according to claim 3 having substantially the same XRPD pattern as depicted in FIG. 1 .
5. An amorphous sodium metal salt of dexlansoprazole according to claim 3 , wherein the salt has high purity.
6. An amorphous sodium metal of claim 5 wherein the high purity is not less than 98.5% chromatographic purity.
7. An amorphous sodium metal of claim 5 wherein the high purity is not less than 99% chromatographic purity.
8. An amorphous sodium metal of claim 5 wherein the high purity is not less than 99% chiral purity.