Purine nucleoside phosphoramidate

1. A compound represented by formula 1, its hydrate or solvate thereof in crystalline or crystal-like form.

2. The compound of claim 1 , represented by 1.mH 2 O, wherein m varies in an integer or non-integer amount from about 0 to about 5 and is not 0.

3. The compound of claim 2 , wherein m is about 1.

4. The compound of claim 2 , wherein m is about ½.

5. The compound of claim 2 , wherein m is about 1, that further comprises an amount of adsorbed water.

6. The compound of claim 5 , wherein the amount of adsorbed water ranges from about 0 wt. % to about 10 wt. % based on the weight of the 1.H 2 O.

7. The compound of claim 2 , wherein the compound is a monohydrate in crystalline form.

8. The compound of claim 7 having an XRPD 2θ-reflection (°) at about 14.8.

9. The compound of claim 8 having XRPD 2θ-reflections (°) at about 14.8 and about 17.6.

10. The compound of claim 9 having XRPD 2θ-reflections (°) at about 20.4.

11. The compound of claim 9 having XRPD 2θ-reflections (°) at about 8.7.

12. The compound of claim 9 having XRPD 2θ-reflections (°) at about 13.6.

13. The compound of claim 9 having XRPD 2θ-reflections (°) at about.

14. The compound of claim 9 having a pattern substantially as that shown in FIG. 1 .

15. The compound of claim 7 , wherein the compound is an orthorhombic crystalline.

16. The orthorhombic crystalline of claim 15 , having the following unit cell parameters a˜10.99 Å, b˜13.09 Å, and c˜20.36 Å.

17. A composition comprising the compound of claim 1 .

18. A method for treating HCV in a patient in need thereof, which comprises administering to the patient a therapeutically effective amount of the compound of claim 1 .

19. A method for treating HCV in a patient in need thereof, which comprises administering to the patient a therapeutically effective amount of the compound of claim 7 .

20. A method for treating HCV in a patient in need thereof, which comprises administering to the patient a therapeutically effective amount of the compound of claim 1 in combination or in alternation with a therapeutically effective amount of another antiviral.

21. The method of claim 20 , wherein the other antiviral is selected from the group consisting of

telaprevir; boceprevir; BMS-790052; ITMN-191; ANA-598; TMC435; and combinations thereof.

22. A co-therapy method for treating HCV in a patient in need thereof, which comprises administering to the patient a therapeutically effective amount of the compound of claim 7 in combination or in alternation with a therapeutically effective amount of another antiviral.

23. The co-therapy method of claim 22 , wherein the other antiviral is selected from the group consisting of

telaprevir; boceprevir; BMS-790052; ITMN-191; ANA-598; TMC435; and combinations thereof.

24. A process for preparing the compound of claim 1 in a crystalline form, which comprises crystallizing the compound of claim 1 .

25. The process of claim 24 , which further comprises dissolving or suspending the compound of claim 1 in a solvent or solvent mixture.

26. The process of claim 25 , wherein the solvent or solvent mixture is selected from the group consisting of anisole, ethyl acetate; xylenes; toluene; isopropanol; acetone; dichloromethane; diethyl ether; isopropyl acetate; t-butyl methyl ether; and combinations thereof.

27. The process of claim 25 , wherein the solvent mixture is selected from the group consisting of anisole/ethyl acetate; heptanes/ethyl acetate; xylenes/ethyl acetate/water; anisole/water; ethyl acetate/xylenes; isopropanol/xylenes; acetone/xylenes; dichloromethane/xylenes; dichloromethane/hexanes; ethyl acetate/toluene; diethyl ether/xylenes; isopropyl acetate/xylenes; isopropyl acetate/heptanes; ethyl acetate/water; t-butyl methyl ether/water; and t-butyl methyl ether/ethyl ether.

28. A method for determining the crystallinity of the compound of claim 1 , which comprises analyzing the compound by XRPD or single-crystal X-ray crystallography.