SPL Set ID: db3ba268-21a2-4988-b5c1-353741bcaee5

Quetiapine, USP is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [ b,f ] [1,4] thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C 42 H 50 N 6 O 4 S 2 •C 4 H 4 O 4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is: Quetiapine fumarate, USP is a white to off-white crystalline powder which is soluble in 0.1N hydrochloric acid, very slightly soluble in water and sparingly soluble in ethanol and methanol. Quetiapine extended-release tablets, USP are supplied for oral administration as 150 mg (white) and 200 mg (yellow). 150 mg tablets are oval shaped while 200 mg tablets are capsule shaped, film-coated. Inactive ingredients for quetiapine extended-release tablets, USP are lactose monohydrate, microcrystalline cellulose, sodium citrate dihydrate, hypromellose, methacrylic acid and ethyl acrylate copolymer and magnesium stearate. The film coating for both quetiapine extended-release tablets contains polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, yellow iron oxide, FD&C Yellow #6 and black iron oxide are included in the film coating of 200 mg strength. Each 150 mg tablet contains 172.7 mg of quetiapine fumarate, USP equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.3 mg of quetiapine fumarate, USP equivalent to 200 mg quetiapine. FDA approved dissolution test specifications differ from USP. Chemical structure