Solid forms of bendamustine hydrochloride

1. A crystalline form of bendamustine hydrochloride that is Form 3 that produces an X-ray powder diffraction pattern having peaks at 7.9 and 15.5±0.2 degrees 2θ.

2. The crystalline form of claim 1 , wherein the X-ray powder diffraction pattern further comprises a peak selected from the group consisting of 10.6, 21.3, 22.1, 23.3 and 26.1±0.2 degrees 2θ.

3. A composition comprising at least one pharmaceutically acceptable excipient and a crystalline form of bendamustine hydrochloride that is Form 3, wherein the composition produces an X-ray powder diffraction pattern having peaks at 7.9 and 15.5±0.2 degrees 2θ.

4. The composition of claim 3 , wherein the X-ray powder diffraction pattern further comprises a peak selected from the group consisting of 10.6, 21.3, 22.1, 23.3 and 26.1±0.2 degrees 2θ.

5. The composition of claim 3 , wherein the excipient is sodium phosphate, potassium phosphate, citric acid, tartaric acid, gelatin, glycine, mannitol, lactose, sucrose, maltose, glycerin, dextrose, dextran, trehalose, hetastarch, or a mixture thereof.

6. The composition of claim 3 , wherein the excipient is mannitol.

7. The composition of claim 3 , further comprising bendamustine hydrochloride monohydrate.

8. The composition of claim 3 , further comprising amorphous bendamustine hydrochloride.

9. The composition of claim 3 , further comprising bendamustine hydrochloride monohydrate and amorphous bendamustine hydrochloride.

10. A method of treating chronic lymphocytic leukemia, Hodgkin's disease, non-Hodgkin's lymphoma, multiple myeloma, or breast cancer in a patient in need thereof comprising administering to the patient a composition according to claim 3 .

11. The method according to claim 10 , wherein the non-Hodgkin's lymphoma is indolent B-cell non-Hodgkin's lymphoma.

12. The method according to claim 10 , comprising administering the composition as a reconstituted injectable preparation.