SPL Set ID: b0cce89c-0e84-4f60-8e50-0e26c41c2613

Quetiapine 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 is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine extended-release tablets, USP, are supplied for oral administration as 50 mg (pink), 150 mg (white), 200 mg (yellow), 300 mg (yellow) and 400 mg (white). All tablets are capsule shaped and film coated. Inactive ingredients for quetiapine extended-release tablets are hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium citrate. Inactive ingredients of the film coats are slightly different among the 5 strengths of tablets and are tabulated below: Strength Inactive ingredients of the film coat 50 mg polyvinyl alcohol-part. hydrolyzed, polyethylene glycol, titanium dioxide, talc, lecithin (soya) and Iron oxide red 150 mg polyvinyl alcohol-part. hydrolyzed, polyethylene glycol, titanium dioxide, talc and lecithin (soya) 200 mg polyvinyl alcohol-part. hydrolyzed, polyethylene glycol, titanium dioxide, talc, D&C Yellow #10 Aluminum Lake and Iron oxide red 300 mg polyvinyl alcohol-part. hydrolyzed, polyethylene glycol, titanium dioxide, talc and iron oxide yellow 400 mg polyvinyl alcohol-part. hydrolyzed, polyethylene glycol, titanium dioxide, talc and lecithin (soya) Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 150 mg tablet contains 172.69 mg of quetiapine fumarate equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.38 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.50 mg of quetiapine fumarate equivalent to 400 mg quetiapine. FDA approved dissolution test specifications differ from USP. structural formula