SPL Set ID: 4202cbfb-52e9-47f2-bd3a-1003319ca3cb

Tetracycline, USP is a yellow, odorless, crystalline powder. Tetracycline is stable in air but exposure to strong sunlight causes it to darken. Its potency is affected in solutions of pH below 2 and is rapidly destroyed by alkali hydroxide solutions. Tetracycline, USP is very slightly soluble in water, freely soluble in dilute acid and in alkali hydroxide solutions, sparingly soluble in alcohol, and practically insoluble in chloroform and in ether. The chemical name for tetracycline hydrochloride is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,-12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecar-boxamide monohydrochloride. Each capsule, for oral administration, contains tetracycline hydrochloride USP, 250 mg or 500 mg. Inactive Ingredients: Lactose, magnesium stearate, and sodium lauryl sulfate. The 250 mg capsule shell contains D&C yellow no. 10, FD&C yellow no. 6, gelatin, sodium lauryl sulfate, and titanium dioxide. It may also contain benzyl alcohol, butylparaben, D&C red no. 22, edetate calcium disodium, methylparaben, propylparaben, silicon dioxide, and sodium propionate. The imprinting ink for the 250 mg capsule contains pharmaceutical glaze, and synthetic black iron oxide. It may also contain D&C yellow no. 10 (aluminum lake), dimethylpolysiloxane, distilled water, ethylene glycol monoethyl ether, FD&C blue no. 1 (aluminum lake), FD&C blue no. 2 (aluminum lake), FD&C red no. 40 (aluminum lake), lecithin, n-butyl alcohol, propylene alcohol, and SDA-3A alcohol. The 500 mg capsule shell contains D&C yellow no. 10, FD&C blue no.1, FD&C red no. 40, gelatin, sodium lauryl sulfate, and titanium dioxide. It may also contain benzyl alcohol, butylparaben, edetate calcium disodium, FD&C yellow no. 6, methylparaben, propylparaben, silicon dioxide, and sodium propionate. The imprinting ink for the 500 mg capsule contains titanium dioxide. It may also contain dimethyl polysiloxane, distilled water, ethyl alcohol, ethylene glycol monoethyl ether, pharmaceutical glaze, pharmaceutical shellac, and soya lecithin. Its structural formula is as follows: new