High-purity large-scale preparation of stannsoporfin
Large scale (bulk) compositions comprising high-purity stannsoporfin are disclosed, as well as methods of synthesizing such compositions.
1. A composition comprising stannsoporfin, wherein the stannsoporfin is at least about 97% pure, and wherein any individual impurity is present in an amount less than about 0.08%.
2. The composition of claim 1 , wherein the stannsoporfin is at least about 98.5% pure.
3. The composition of claim 1 , wherein the composition comprises palladium in an amount of less than about 20 ppm.
4. The composition of claim 1 , wherein the composition comprises palladium in an amount of less than about 10 ppm.
5. The composition of claim 1 , wherein any impurity present is present in an amount of about 0.07% or less.
6. The composition of claim 1 , wherein the composition has a pH of about 7.0 to about 8.0.
7. The composition of claim 1 , wherein the composition has a pH of about 7.2 to about 7.9.
8. The composition of claim 1 , comprising at least about 10 grams of stannsoporfin.
9. The composition of claim 1 , comprising at least about 100 grams of stannsoporfin.
10. The composition of claim 1 , comprising at least about 10 grams of stannsoporfin, wherein the composition contains palladium in an amount of less than about 20 ppm.
11. The composition of claim 10 , wherein the stannsoporfin is a single-batch preparation of stannsoporfin.
12. The composition of claim 1 , wherein the composition further comprises at least one impurity in an amount between about 0.05% and about 0.08%, the at least one impurity having a relative retention time of 0.72-0.73 in an HPLC analysis.
13. A pharmaceutical composition comprising stannsoporfin and a pharmaceutically acceptable carrier, wherein the stannsoporfin is at least about 97% pure, and wherein any individual impurity is present in an amount less than about 0.08%.
14. The pharmaceutical composition of claim 13 , wherein the stannsoporfin is present in an amount suitable for delivering up to a 4.5 mg/kg dose by birth weight.
15. The pharmaceutical composition of claim 13 , wherein the stannsoporfin is present in an amount suitable for delivering a dose of about 1.5 mg/kg to about 3.0 mg/kg by birth weight.
16. The pharmaceutical composition of claim 13 , wherein the pharmaceutical composition has a pH of about 7.0 to about 8.0.
17. The pharmaceutical composition of claim 13 , wherein the pharmaceutical composition has a pH of about 7.2 to about 7.9.
18. The pharmaceutical composition of claim 13 , wherein the stannsoporfin is at least about 98.5% pure.
19. The pharmaceutical composition of claim 13 , wherein the pharmaceutical composition comprises palladium in an amount of less than about 20 ppm.
20. The pharmaceutical composition of claim 13 , wherein the pharmaceutical composition comprises palladium in an amount of less than about 10 ppm.