111974-72-2 Quetiapine fumarate Quetiapine hemifumarate
Name:Quetiapine fumarate
Molecular Formula:2(C21H25N3O2S).C4H4O4
CAS No.:111974-72-2
Purity:99%
Synonyms:2-[2-(4-dibenzo[b,f][1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]ethanol hemifumarate
Molecular Weight:883.09
Appearance:White powder
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% |
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