pms-Quetiapine

pms-Quetiapine Description

quetiapine

Manufacturer:

Pharmascience

Distributor:

T-BOMA
Full Prescribing Info
Description
pms-QUETIAPINE contains 25 mg, 50 mg, 100 mg or 200 mg quetiapine per tablet (as quetiapine fumarate).
Proper Name: quetiapine fumarate.
Chemical Name: Bis[2-(2-[4-(dibenzo[b,f][1,4]thiazepin-11- yl)piperazin- 1yl] ethoxy)ethanol] fumarate (IUPAC).
Code Name: ICI 204, 636 fumarate.
Molecular Formula: C42H50O4N6S2 · C4H4O4.
Molecular Mass: 883.1 g/mol.
Physiochemical Properties: Description: Quetiapine fumarate is a white to off-white powder. It is only very slightly soluble in ether, slightly soluble in water, and soluble in 0.1 N HCl.
Ionization Constant: pKa1 = 6.83 in phosphate buffer at 22°C; pKa2 = 3.32 in formic buffer at 22°C.
Partition Coefficient: Log P = 0.45 (octanol/water).
Melting Point: 172 - 174°C.
Excipients/Inactive Ingredients: Tablet core: Dibasic Calcium Phosphate, Lactose Monohydrate, Magnesium Stearate, Microcrystalline cellulose, povidone and sodium starch glycolate.
Tablet coating: Polyethylene Glycol, Titanium Dioxide and Hydroxypropyl Methylcellulose.
25 mg: Iron Oxide Red and Iron Oxide Yellow.
50 mg and 100 mg: Iron Oxide Yellow.
200 mg: Talc.
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