CYSTEINE COMPOSITION AND INJECTION
Cysteine compositions comprising less than about 400 μg/L of aluminum. For example, solutions of cysteine comprising a pharmaceutically acceptable solvent, cysteine, and less than about 145 μg/L of aluminum, wherein the solution is devoid of visible particulate matter. Cysteine compositions described herein may be suitable for injection. For example, disclosed cysteine solutions may be provided intravenously to meet amino acid nutritional requirement in individuals receiving total parenteral nutrition. Also provided are processes for preparing cysteine compositions, and methods for providing cysteine to individuals in need thereof.
1 .- 25 . (canceled)
26 . A process for preparing a solution of cysteine hydrochloride, the process comprising:
acidifying water to a pH from about 1.0 to about 2.5; and
contacting the acidified water with cysteine hydrochloride to form a solution.
27 . The process of claim 26 , wherein the acidifying is performed under flow of an inert gas.
28 . The process of claim 26 , further comprising sparging the water with an inert gas to achieve a dissolved oxygen content of less than 2 mg/L in the water prior to the acidifying.
29 . The process of claim 26 , wherein the acidifying comprises adding hydrochloric acid.
30 . The process of claim 29 , wherein the hydrochloric acid is sparged with an inert gas prior to achieve a dissolved oxygen content of less than 2 mg/L in the hydrochloric acid prior to addition to the water.
31 . The process of claim 26 , wherein the pH of the acidified water is from about 1.0 to about 1.5.
32 . The process of claim 26 , wherein the contacting comprises stirring the acidified water and cysteine hydrochloride under flow of an inert gas.
33 . The process of claim 26 , wherein the contacting comprises adding about 40 mg to about 60 mg of cysteine hydrochloride per 1 mL of acidified water.
34 . The process of claim 26 , wherein the contacting comprises adding about 50 mg of cysteine hydrochloride per 1 mL of acidified water.
35 . The process of claim 26 , wherein the acidifying and contacting are performed at ambient temperature.
36 . The process of claim 26 , wherein the solution of cysteine hydrochloride has a pH from about 1.0 to about 1.5.
37 . The process of claim 26 , wherein the solution of cysteine hydrochloride has a pH from about 1.0 to about 1.3.
38 . The process of claim 26 , wherein the solution of cysteine hydrochloride comprises about 50 mg/mL of cysteine hydrochloride.
39 . The process of claim 26 , wherein the solution of cysteine hydrochloride has a dissolved oxygen content of less than 2 mg/L.
40 . The process of claim 26 , wherein the solution of cysteine hydrochloride has an aluminum content of less than about 145 μg/L.
41 . The process of claim 26 , wherein the solution of cysteine hydrochloride has an aluminum content of less than about 10 μg/L.
42 . The process of claim 26 , wherein the solution of cysteine hydrochloride is free of visible particulate matter.
43 . The process of claim 26 , further comprising filling and sealing a container with the solution, wherein the solution is disposed under flow of an inert gas during the filling and sealing.
44 . The process of claim 43 , wherein the container is a silica-lined glass vial.
45 . The process of claim 43 , wherein the filling and sealing are performed at ambient temperature.
46 . The process of claim 43 , further comprising sterile filtering the solution prior to the filling and sealing.
47 . The process of claim 43 , wherein the solution of cysteine hydrochloride has a dissolved oxygen content of less than 2 mg/L.
48 . The process of claim 43 , wherein the solution of cysteine hydrochloride is free of visible particulate matter when stored for at least six months at 25° C. and 60% relative humidity.
49 . The process of claim 43 , wherein the solution of cysteine hydrochloride is free of visible particulate matter when stored for at least 12 months at 25° C. and 60% relative humidity.
50 . The process of claim 43 , wherein the solution of cysteine hydrochloride is free of visible particulate matter when stored for at least 24 months at 25° C. and 60% relative humidity.