Table 1.
Raw material/excipient | Gluten concentration (ppm) |
---|---|
Levothyroxine sodium, USP | <3.0 |
Talc, USP | <3.0 |
Lactose monohydrate, NF | <3.0 |
Acacia, NF | <3.0 |
Sugar, confectioner’s, NF | <3.0 |
Magnesium stearate, NF/EP | <3.0 |
Povidone, USP | <3.0 |
Dye, Yellow D&C No. 10, Aluminum Lake | <3.0 |
Dye, Blue FD&C No. 1, Aluminum Lake | <3.0 |
Dye, Yellow FD&C No. 6, Aluminum Lake | <3.0 |
Dye, Blue FD&C No. 2, Aluminum Lake | <3.0 |
Dye, Red FD&C No. 40, Aluminum Lake | <3.0 |
Dye, Red Lake Blend | <3.0 |
Dye, Brown Lake Blend | <3.0 |
Dye, Olive Lake blend | <3.0 |
EP European Pharmacopoeia, FD&C Federal Food, Drug, and Cosmetic Act, NF National Formulary, USP US Pharmacopeia