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Farmacia Materias Activos en 161

Desloratadine is a pale yellow to creamish white or white powder that is freely soluble in methanol and dichloromethane but insoluble in n-hexane. It must meet specifications for identification via IR absorption spectrum and X-ray diffraction pattern, clarity of a 5% methanol solution, color index of a 5% methanol solution, loss on drying of not more than 0.5% w/w, and water content of not more than 0.5% w/w as determined by Karl Fischer titration.

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33 views1 page

Farmacia Materias Activos en 161

Desloratadine is a pale yellow to creamish white or white powder that is freely soluble in methanol and dichloromethane but insoluble in n-hexane. It must meet specifications for identification via IR absorption spectrum and X-ray diffraction pattern, clarity of a 5% methanol solution, color index of a 5% methanol solution, loss on drying of not more than 0.5% w/w, and water content of not more than 0.5% w/w as determined by Karl Fischer titration.

Uploaded by

nhan pham
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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PRODUCT: DESLORATADINE

ITEMS SPECIFICATIONS

Pale yellow to creamish white or white


DESCRIPTION powder

SOLUBILITY Freely soluble in methanol and


dichloromethane, insoluble in n-hexane

IDENTIFICATION
a) IR Absorption The IR Absorption spectrum of the sample
in Potassium bromide dispersion should
be concordant with the similarly recorded
spectrum of desloratadine working
standard.

b) X-ray-diffraction Polymorphic content of form-II should be


5 to 80% when determined by powder X-
ray diffraction method.

CLARITY OF SOLUTION % Transmittance of 1 cm layer of 5% w/v


solution in methanol at 650 nm should not
be less than 95.0%

COLOUR INDEX Absorbance of 1cm layer of 5% w/v


solution in methanol at 420 nm should not
more be than 0.30 Au.

LOSS ON DRYING NMT 0.50% w/w

WATER CONTENT (By KF) NMT 0.50% w/w

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