High-purity large-scale preparation of stannsoporfin

1. A method of treating a condition selected from hyperbilirubinemia or elevated serum levels of bilirubin in a subject, the method comprising administering a composition comprising stannsoporfin, wherein said stannsoporfin is at least about 98.5% pure and wherein any individual impurity is present in an amount of less than about 0.1%.

2. The method of claim 1 , wherein said stannsoporfin is administered by injection.

3. The method of claim 1 , wherein said stannsoporfin is administered by intramuscular injection.

4. The method of claim 1 , wherein said subject is an infant.

5. The method of claim 1 , wherein a therapeutically effective amount is 0.5 mg/kg to 25 mg/kg body weight.

6. The method of claim 1 , wherein a therapeutically effective amount is selected from about 1.5 mg/kg, about 3.0 mg/kg and about 4.5 mg/kg body weight.

7. The method of claim 1 , wherein a therapeutically effective amount is from about 1.5 mg/kg to about 4.5 mg/kg.

8. The method of claim 1 , wherein a therapeutically effective amount is from about 1.5 mg/kg to about 3.0 mg/kg.

9. The method of claim 1 , wherein said stannsoporfin is at least about 99% pure.

10. The method of claim 1 , wherein said stannsoporfin is dissolved in a pharmaceutically acceptable vehicle.

11. The method of claim 1 , wherein said stannsoporfin is provided in a solution which can be buffered to maintain a suitable pH.

12. The method of claim 11 , wherein the suitable pH is between about 7.0 and about 8.0.

13. The method of claim 11 , wherein the suitable pH is between about 7.2 and about 7.9.

14. The method of claim 11 , wherein the suitable pH is about 7.4.

15. The method of claim 11 wherein the osmolarity of the solution is between about 280 mOsm/L and 310 mOsm/L.

16. A method of treating a condition selected from hyperbilirubinemia or elevated serum levels of bilirubin in an infant, the method comprising administering by intramuscular injection to said infant a composition comprising stannsoporfin, wherein said stannsoporfin is at least about 98.5% pure and wherein any individual impurity is present in an amount of less than about 0.1%; and wherein a therapeutically effective amount is from about 1.5 mg/kg to about 4.5 mg/kg birth weight of said infant.

17. The method of claim 16 , wherein a therapeutically effective amount is about 1.5 mg/kg.

18. The method of claim 16 , wherein a therapeutically effective amount is about 3.0 mg/kg.

19. The method of claim 16 , wherein a therapeutically effective amount is about 4.0 mg/kg.

20. The method of claim 16 , wherein a therapeutically effective amount is about 4.5 mg/kg.