Patent ID: 7638556

Claim:
A composition consisting of a freeze-dried solution of N-[o-(p-pivaloyloxybenzenesulfonylamino)benzoyl]glycine monosodium salt tetra-hydrate of formula (I), and D-mannitol, which is stable after a preservation under an accelerated condition, wherein the ratio of the compound of formula (I) to D-mannitol is 400 to 100 by weight, wherein said freeze-dried solution is prepared by freeze-drying a solution of the compound of formula (I) in a mixed solvent of water and ethanol, the ratio of ethanol to water being 3.0/7.0˜4.0/6.0 (v/v), and wherein the compound of formula (I) is present in the solution in an amount of from 80 mg/ml-166.67 mg/ml, and wherein the composition is suitable for injection into a subject.