Quetiapine fumarate/111974-72-2 CAS NO.111974-72-2

items of test

as per company standard ws1-(x-133)-2003z &

zlbz-e023-3

result

characters

appearance: white or pale yellow crystalline

powder, odorless and tasteless.

complies

solubility : freely soluble in glacial acetic acid;

slightly soluble in methanol or ethanol; practically

insoluble in water.

complies

identification

a reaction with kmno4 ts produces brown

precipitate.

complies

b light absorption has maximum at 289±1nm.

complies

c ir spectrum is concordance with the reference

one.

complies

d melting point: 172-176°c with melting

range≤4°c

173.5-174.0°c

phvalue

0.01g/ml solution,5.0-6.0

5.6

related substances

(hplc)

any impurity ≤0.10%

< 0.10%

total of all impurities ≤0.20%

<0.20%

loss on drying

≤0.5%

0.1%

residue on ignition

≤0.1%

<0.1%

chloride

≤140ppm

< 140ppm

heavy metals

≤10ppm

<10ppm

assay

not less than 99.0%

99.7%