Process for purifying noroxymorphone
AssigneeRhodes Technologies
InventorC. Frederick M. HUNTLEY
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Abstract
The application is directed to a process of purifying noroxymorphone by preparing and isolating noroxymorphone bisulfite adduct and regenerating purified noroxymorphone from noroxymorphone bisulfite adduct. The application is also directed to a compound represented by the Formula I, described herein, or a hydrate or zwitterion thereof, and a crystalline form of noroxymorphone bisulfite adduct monohydrate.
Claims51
A process for preparing noroxymorphone bisulfite adduct, said process comprising:
- mixing an aqueous composition comprising noroxymorphone and a source of sulfurous acid;
- and
- isolating said noroxymorphone bisulfite adduct from the aqueous composition.
The process of claim 1, 6, or 7, wherein the source of sulfurous acid is a sulfite salt and an acid. The process of claim 4 or 14, wherein said mixing is carried out by adding solid sulfite salt to said aqueous composition comprising noroxymorphone and said acid.
The process of any one of the preceding claims, wherein said aqueous composition further comprises an organic co-solvent.
The process of any one of the preceding claims, wherein said mixing is carried out at a room temperature or at an elevated temperature. The process of claim 29, wherein said mixing is carried out at a temperature of about 40° C. to about 90° C.
The process of any one of the preceding claims, wherein said aqueous composition comprising said noroxymorphone bisulfite adduct is first allowed to cool to room temperature and then said noroxymorphone bisulfite adduct is isolated by filtration.
A compound represented by the formula I
- or a hydrate or zwitterion thereof.
A crystalline Form A of noroxymorphone bisulfite adduct monohydrate, characterized as exhibiting an x-ray powder diffraction (XRPD) pattern substantially similar to that of FIG. 2.
A crystalline Form A of noroxymorphone bisulfite adduct monohydrate, characterized as exhibiting an XRPD pattern having peaks at 11.8±0.2, 13.2±0.2, and 16.7±0.2 degrees two theta when measured by Cu Kα radiation.
A process for purifying noroxymorphone, said process comprising:
- providing an aqueous composition comprising noroxymorphone and one or more colored impurities;
- forming a bisulfite adduct of said noroxymorphone;
- and
- regenerating purified noroxymorphone from said noroxymorphone bisulfite adduct.
Dependencies are inferred from the claim text.