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Impurity profile of Rexulti TM Tablet

IP.com Disclosure Number: IPCOM000245389D
Publication Date: 2016-Mar-06
Document File: 1 page(s) / 151K

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The IP.com Prior Art Database

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Impurity profile of Rexulti TM Tablet

7-{4-[4-(1-benzothiophen-4-yl)piperazin-1-yl]butoxy}quinolin-2(1H)-one has the following structure and is known as Brexpiprazole:

Brexpiprazole is a novel atypical antipsychotic drug. Brexpiprazole API was formulated as Rexulti

TM Tablet.

A Rexulti TM tablet was analyzed to determine its impurity profile.

Analysis of Rexulti TM 4mg Tablet (US market, Batch No. BPS00115A, Exp.date Oct 2017):

A solution containing about 0.6mg/ml of Brexpiprazole was prepared by the following way:

To one Rexulti TM milled tablet of 4mg was added 1ml of Formic acid, sonicated and diluted up to 10ml with Acetonitrile : Water = 50 : 50. The obtained suspension was filtered and analyzed by HPLC.

The HPLC conditions were used the following:

Column:

Eluent A:

Eluent B:

Gradient:

Flow:

Detection:

The following Impurity profile results were obtained:

RT

RRT

            0.67 0.69 1.00 1.04 1.54 1.60 Rexulti TM 4mg 0.11 0.07 99.64 0.10 0.05 0.05

XBridge C18 150x4.6mm 3.5┬Ám

Buffer : Acetonitrile = 80 : 20

Buffer : Acetonitrile = 5 : 95

Gradient elution


0.5ml/min

UV 276nm


9.84 10.15 14.78 15.45 22.76 23.60