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 . A solution of cysteine comprising a pharmaceutically acceptable solvent, about 40 mg/mL to about 60 mg/mL of cysteine hydrochloride, less than about 200 μg/L of aluminum, and a pH from about 1.0 to about 1.5, wherein the solution is devoid of visible particulate matter and is suitable for use as an additive in a total parenteral nutrition formulation for a neonate or an infant.
2 . The solution of claim 1 , which comprises from 42.5 mg/mL to 57.5 mg/mL of cysteine hydrochloride monohydrate.
3 . The solution of claim 1 which comprises about 50 mg/mL of cysteine hydrochloride monohydrate.
4 . The solution of claim 1 , which comprises less than about 145 μg/L of aluminum.
5 . The solution of claim 4 , which comprises less than about 100 μg/L of aluminum.
6 . The solution of claim 5 , which comprises less than about 30 μg/L of aluminum.
7 . The solution of claim 6 , which comprises less than about 10 μg/L of aluminum.
8 . The solution of claim 1 , which comprises from about 1 μg/L to about 145 μg/L of aluminum.
9 . The solution of claim 1 , which comprises from about 0 μg/L to about 100 μg/L of aluminum.
10 . The solution of claim 1 , wherein the pH is from about 1.0 to about 1.3.
11 . The solution of claim 1 , which has a dissolved oxygen content of less than 2 mg/L.
12 . (canceled)
13 . The solution of claim 1 , which has a cystine content of less than about 1% by weight of the total cysteine present in the solution.
14 . The solution of claim 1 , wherein the pharmaceutically acceptable solvent is water.
15 . A sterile solution of about 50 mg/mL of cysteine hydrochloride in water for injection, wherein the sterile solution has a pH from about 1.0 to about 1.5 and an aluminum content of less than about 145 μg/L, wherein the sterile solution is provided in a silica-lined glass vial and is suitable for use as an additive in a total parenteral nutrition formulation for a neonate or an infant.
16 . The sterile solution of claim 15 , wherein the pH is from about 1.0 to about 1.3.
17 . (canceled)
18 . The sterile solution of claim 15 , wherein the aluminum content is less than about 100 μg/L.
19 . The sterile solution of claim 18 , wherein the aluminum content is less than about 30 μg/L.
20 .- 27 . (canceled)
28 . The sterile solution of claim 15 , wherein the aluminum content is from about 0 μg/L to about 30 μg/L.
29 . (canceled)
30 . The sterile solution of claim 15 , which has a dissolved oxygen content of less than 2 mg/L.
31 . The sterile solution of claim 15 , which is devoid of visible particulate matter when stored for one month at 25° C. and 60% relative humidity.
32 . The sterile solution of claim 31 , which is devoid of visible particulate matter when stored for six months at 25° C. and 60% relative humidity.
33 . The sterile solution of claim 32 , which is devoid of visible particulate matter when stored for nine months at 25° C. and 60% relative humidity
34 . The sterile solution of claim 33 , which is devoid of visible particulate matter when stored for 12 months at 25° C. and 60% relative humidity.
35 . The sterile solution of claim 34 , which is devoid of visible particulate matter when stored for 18 months at 25° C. and 60% relative humidity.
36 . The sterile solution of claim 35 , which is devoid of visible particulate matter when stored for 24 months at 25° C. and 60% relative humidity.
37 . The sterile solution of claim 15 , wherein the aluminum content is less than about 145 μg/L when stored for six months at 25° C. and 60% relative humidity.
38 . The sterile solution of claim 37 , wherein the aluminum content is less than about 145 μg/L when stored for 12 months at 25° C. and 60% relative humidity.
39 . The sterile solution of claim 38 , wherein the aluminum content is less than about 145 μg/L when stored for 24 months at 25° C. and 60% relative humidity.
40 . The sterile solution of claim 15 , wherein the silica-lined glass vial is filled and sealed under flow of an inert gas.