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. 2017 Jun 26;34(7):1764–1769. doi: 10.1007/s12325-017-0575-y

Table 1.

Gluten test results of raw materials used in the manufacture of Synthroid® tablets

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