Claims
- 1. A method for the synthesis of histamine dihydrochloride comprising:
forming a histamine monohydrochloride solution by decarboxylating a L-histidine solution in the absence of a decarboxylating enzyme, and providing hydrogen chloride thereto; and forming a histamine dihydrochloride containing solution from the histamine monohydrochloride containing solution.
- 2. The method of claim 1, wherein the histamine monohydrochloride solution is formed by triturating the decarboxylated L-histidine solution.
- 3. The method of claim 2, wherein the histamine monohydrochloride containing solution is triturated with a methylene chloride solution.
- 4. The method of claim 1, wherein the histamine monohydrochloride containing solution is formed by addition of an effective amount of hydrochloric acid in an isopropanol solution.
- 5. The method of claim 4, wherein the effective amount of hydrochloric acid is about 0.1 to 0.9 molar equivalents of hydrochloric acid to histamine free base.
- 6. The method of claim 4, wherein the effective amount of hydrochloric acid is about 0.6 molar equivalents of hydrochloric acid to histamine free base.
- 7. The method of claim 1, further comprises the ste p of isolating a pharmaceutical grade of histamine dihydrochloride from the histamine dihydrochloride containing solution.
- 8. The method of claim 7, wherein the histamine dihydrochloride contains equal to or less than each of the following: 0.8% L-histidine HCl monohydrate, 0.1% individual chromatographic impurities, and 2% total impurities.
- 9. A histamine dihydrochloride solution prepared by forming a histamine monohydrochloride solution by decarboxylating a L-histidine solution in the absence of a decarboxylating enzyme, and providing hydrogen chloride; and
forming a histamine dihydrochloride containing solution from the histamine monohydrochloride containing solution.
RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent application Ser. No. 09/467,652, now U.S. Pat. No. ______, which claims priority to U.S. provisional patent application No. 60/113,933, both of which are hereby incorporated by reference in their entirety.
Provisional Applications (1)
|
Number |
Date |
Country |
|
60113933 |
Dec 1998 |
US |
Continuations (1)
|
Number |
Date |
Country |
Parent |
09467652 |
Dec 1999 |
US |
Child |
09974469 |
Oct 2001 |
US |