Ready-to-use bivalirudin compositions

An aqueous, injectable composition that has not been reconstituted from a lyophilizate, comprising:

• (i) bivalirudin (SEQ ID NO:
• 1), or salts thereof, at a concentration of about 1 mg/mL to about 10 mg/mL;
• (ii) one or more pharmaceutically acceptable stabilizing agents, wherein at least one of the stabilizing agents is a buffering agent having a pKa of about 2.5 to about 6.5;
• (iii) a pH of about 4 to less than 5;
• and
• (iv) total impurities in an amount less than about 12% area-under-the-curve (“AUC”) as determined by high performance liquid chromatography (“HPLC”) at a wavelength of 215 nm after storage at about 2° C. to about 8° C. for 12 months.

An aqueous, injectable composition that has not been reconstituted from a lyophilizate, comprising:

• (i) bivalirudin (SEQ ID NO:
• 1), or salts thereof, at a concentration of about 1 mg/mL to about 10 mg/mL;
• (ii) one or more pharmaceutically acceptable stabilizing agents, wherein at least one of the stabilizing agents is selected from a group consisting of (a) polymers, and (b) sugars or polyols;
• (iii) a pH of about 4 to less than 5 as obtained by a pH-adjusting agent;
• and
• (iv) total impurities present in an amount less than about 15% area-under-the-curve (“AUC”) as determined by high performance liquid chromatography (“HPLC”) at a wavelength of 215 nm after storage at 25° C. for 1 month.

An aqueous, injectable composition that has not been reconstituted from a lyophilizate, comprising:

• (i) bivalirudin in an amount of about 5 mg/mL;
• (ii) a buffering agent having a pKa of about 2.5 to about 6.5, wherein the buffering agent is acetate;
• (iii) a pH of about 4.2;
• and
• (iv) total impurities in an amount less than about 15% area-under-the-curve (“AUC”) as determined by high performance liquid chromatography (“HPLC”) at a wavelength of 215 nm after storage at 25° C. for 1 month.

An aqueous, injectable composition that has not been reconstituted from a lyophilizate, comprising:

• (v) bivalirudin, or salts thereof, in an amount of about 5 mg/mL;
• (vi) a buffering agent having a pKa of about 2.5 to about 6.5, wherein the buffering agent is acetate;
• (vii) sodium chloride;
• (viii) a pH of about 4.2;
• and
• (ix) total impurities in an amount less than about 15% area-under-the-curve (“AUC”) as determined by high performance liquid chromatography (“HPLC”) at a wavelength of 215 nm after storage at 25° C. for 1 month.