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LATUDA TABLET

IP.com Disclosure Number: IPCOM000236161D
Publication Date: 2014-Apr-10
Document File: 1 page(s) / 52K

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LATUDA TABLET

((1R, 2S, 3R, 4S)-N-[(1R, 2R)-2-[4-(1, 2-benzisothiazol-3-yl)-piperazin-1-ylmethyl]- cyclohexylmethyl]-bicyclo [2.2.1] heptane-2, 3-dicarboximide hydrochloride), has the following formula:

    Described hereinafter, chromatographic purity profile of Latuda tablet, purchased in US on June 2011, having the following details: Latuda 80mg, 30 Tabs/ lot # G0826430; expiry date: 2013-04-30; Sunovion Pharma.

Latuda® tablets of 80 mg were evaluated for impurity profile by reversed phase HPLC method and for optical isomers by normal phase HPLC method.

Sample preparation:

The tablets were weighed and powdered in mortar. One tablet weight is approximately 328mg and contains about 80 mg of Lurasidone hydrochloride. 135 mg of tablet powder was diluted in 10.0 ml volumetric flask with diluent for reversed phase method and 80 mg of tablet powder was diluted in 20.0 ml volumetric flask with diluent for normal phase method. Solutions were filtered through a filter with
0.45 μm pore size (e.g. GelmanSciences, PVDF Bulk Acrodisc® 13 Minispike 0.45 μm is suitable) and the first 2 ml of filtered sample was discarded.

The obtained purity results are as follows:

Lurasidone chemical purity: at least 99.98 %.

The impurities were found in low levels with total impurity content 0.02 %.

The table below summarizes the impurity profile of Latuda tablet (lurasidone hydrochloride):

  Relative Retention Time

Unknown imp. 1 1.30 0.01 Unknown imp. 2 1.35 0.01

1

                      Area % Lurasidone 1.00 9...