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IMPURITY PROFILE FOR ZYPADHERATM TABLETS

IP.com Disclosure Number: IPCOM000202026D
Publication Date: 2010-Dec-01
Document File: 2 page(s) / 119K

Publishing Venue

The IP.com Prior Art Database

This text was extracted from a PDF file.
This is the abbreviated version, containing approximately 100% of the total text.

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IMPURITY PROFILE FOR ZYPADHERATM TABLETS

2-Methyl-4-(4-methylpiperazin-1-ium-1-yl)-10H-benzo[b]thieno[2,3-e][1,4]diazepin-5-ium 4,4'-methylenebis(3-hydroxy-2-naphthoate) monohydrate, having the following formula:

N N

N

O

HO

O

OHO H

H

O

O

H

H

N

H S

is an antipsychotic for the treatment of schizophrenia and manic episodes. It is marketed under the trade name ZYPADHERATM by Eli Lilly.

Provided are the chromatogram and difractogram of the commercial product.

The impurity profile is detailed below, it is based on %area & RRF calculation of pamoic acid and it's impurities (RRT 0.36, RRT 0.39).

2-methylpropene, acetone, and hexane were found as residual solvents.

6.24
0.36

5.23 PA 0.30

RT/ RRT

6.69 7.55 14.90 16.12 17.33 OLN

0.39 0.44 0.74 0.93

52.81 0.01 0.01 0.03 0.02 0.02 47.11

%Area

 



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The X-ray powder diffraction was performed on a Scintag X-ray powder diffractometer model X'TRA, with a Cu-tube solid-state detector, round standard aluminum sample holder with round zero background quartz plate with a cavity of 25 (diameter)*0.5 (dept.) mm. Copper Kα1 radiation (λ=1.5418 Å) was used. The scanning parameters were as follows: range: 2-40 degrees two-theta; scan mode: continuous scan; step size: 0.05 deg; and scan rate: 3 deg/min.