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Impurity profile of Imbruvica capsules

IP.com Disclosure Number: IPCOM000239744D
Publication Date: 2014-Nov-30
Document File: 1 page(s) / 234K

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Impurity profile of Imbruvica capsules

    (R)-1-(3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1- yl)piperidin-1-yl)prop-2-en-1-one (referred to as Compound 1) has the following formula:

Compound 1 is marketed as ImbruvicaTM capsules.

    An Imbruvica capsule was analyzed to determine impurity profile. Analysis of Imbruvica (US market, Batch No. L0404581; Expiration date Oct


    A solution containing about 0.1 mg/ml of Ibrutinib was prepared (about 40 mg of "Imbruvica" capsule dissolved in 50 ml Ethanol then 3 ml of this solution were diluted up to 10 ml with Acetonitrile : Water 60 : 40 and then filtered into a HPLC vial).

Chromatographic analysis was performed by HPLC, the following results were obtained:

Sample RRT 0.89 0.91 0.95 0.98 1.00 1.03 1.07 1.21

Rt 13.60 13.90 14.50 0.15 15.20 15.60 16.20 18.40

0.04 0.05 0.03 0.06 99.71 0.02 0.08 0.02