SPL Set ID: eafec3a2-4f29-4afa-8728-a62b34cefd18
1 drug(s) with this SPL Set ID
Sapropterin dihydrochloride tablets is an orally administered Phenylalanine Hydroxylase activator (or PAH activator). Sapropterin dihydrochloride, the active pharmaceutical ingredient in sapropterin dihydrochloride tablets, is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4). Sapropterin dihydrochloride is white to off-white crystalline powder. The chemical name of sapropterin dihydrochloride is (6R)-2-amino-6-[(1R,2S)-1,2 dihydroxypropyl]-5,6,7,8-tetrahydro-4(1H)-pteridinone dihydrochloride and the molecular formula is C 9 H 15 N 5 O 3 ·2HCl with a molecular weight of 314.17. Sapropterin dihydrochloride has the following structural formula: Sapropterin dihydrochloride is supplied as tablets containing 100 mg of sapropterin dihydrochloride (equivalent to 76.8 mg of sapropterin base). Tablets are off-white to light yellow, mottled, uncoated, round shaped tablets debossed with ‘P’ on one side and ‘720’ on other side. Each tablet contains the following inactive ingredients: ascorbic acid, colloidal silicon dioxide, copovidone, crospovidone, dibasic calcium phosphate anhydrous, mannitol, riboflavin and sodium stearyl fumarate. sapropterin-dihydrochloride-tablets-2.jpg