SPL Set ID: 6163fc42-5910-4e19-9e32-3d8e81f50128
1 drug(s) with this SPL Set ID
Ursodiol is a bile acid available as 300 mg capsules suitable for oral administration. Ursodiol, USP (ursodeoxycholic acid), is a naturally occurring bile acid found in small quantities in normal human bile and in the biles of certain other mammals. It is a white or almost white crystalline powder, freely soluble in alcohol and glacial acetic acid; slightly soluble in chloroform and ether; and practically insoluble in water. The chemical name for ursodiol is 3α,7β-dihydroxy-5β-cholan-24-oic acid (C 24 H 40 O 4 ). Ursodiol, USP has a molecular weight of 392.6 g/mol. Its structure is shown below: Inactive Ingredients: Hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide and sodium starch glycolate type A. Capsule contains gelatin, FD & C Blue 1, FD & C Red 3 and titanium dioxide. The capsule is printed with black pharmaceutical ink which contains black iron oxide, potassium hydroxide and shellac. FDA approved dissolution method differ from the USP. Image