Example 6
S. NoIngredientsQuantity per mL (A1)Quantity per mL (A2)
1Levothyroxine sodium0.01-2mg0.01-2mg
2Arginine0.01-4mg0.01-4mg
3SBECD100-400100-400
4Potassium sorbate—2-6mg
5Sodium iodide0.5-4.00.5-4.0
6Ultrapure waterq.s to 1.0 mLq.s to 1.0 mL
Manufacturing Process
Ultrapure water was taken in a compounding vessel and SBECD, levothyroxine, Arginine, potassium sorbate and sodium iodide were added and stirred. pH of the solution was adjusted to 6±0.5 with sodium hydroxide or hydrochloric acid. The solution was filtered, followed by filling into suitable containers.
Levothyroxine formulations prepared according to example 6, were tested for stability at 2-8° C., 25±2° C./60±5% RH and 40±2° C./75±5% RH for a period of 3 months. The data is summarized in table 3.
TABLE 3
Stability of the formulation
Stability data
A1A2
Stability duration
1M3M1M3M
Assay
2-8° C.98.397.3100.9100.3
25 ± 2° C./60 ± 5% RH98.397.298.9100.1
40 ± 2° C./75 ± 5% RH97.997.1100.599.8
Total Impurities
2-8° C.0.620.880.660.95
25 ± 2° C./60 ± 5% RH0.620.920.730.95
40 ± 2° C./75 ± 5% RH0.721.160.871.29
