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Impurity profile of ARISTADATM extended-release injectable suspension

IP.com Disclosure Number: IPCOM000245598D
Publication Date: 2016-Mar-21
Document File: 1 page(s) / 319K

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The IP.com Prior Art Database

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Impurity profile of ARISTADATM extended-release injectable suspension

(7-(4-(4-(2,3-dichlorophenyl)piperazin-1-yl)butoxy)-2-oxo-3,4-dihydroquinolin-1(2H)-yl)methyl dodecanoate (Aripiprazole lauroxil) is having the following chemical structure:

Aripiprazole lauroxil is an atypical antipsychotic indicated for the treatment of schizophrenia. This API has been formulated as ARISTADATM injector. An AristadaTM extended-release injectable suspension was analyzed to determine its impurity profile.

Analysis of Aristada 441mg injector (US market, Batch No. NDC:65757-401-03, Exp.date Feb

2018):

The suspension was dissolved in diluent (Concentration: about 1mg/ml), and then filtered into a HPLC vial. Chromatographic analysis was performed by HPLC using the following conditions:

Column:

Eluent A:

Eluent B:

Gradient:

Flow:

Detection:

The following results were obtained:


* QL = 0.05%

Restek, Ultra IBD, 150*4.6mm, 3μm,

Buffer : Acetonitrile = 50 : 50

Ethanol : Acetonitrile : Methanol = 30 : 30 : 40

Gradient elution


0.7ml/min

UV 254nm

RT min 30.75 33.45 RRT 1.00 1.09 % area 99.82 0.07