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Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and along with an antidepressant to treat major depressive disorder. It is also sometimes used as a sleep aid because of its sedating effect but this use is not recommended.
Specification:
|
Items of test |
As per Company Standard |
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% |
Packaging details:
|
Packaging details: |
25kg/drum with double plastic bags inside; packed in a cardboard drum or fiber HDPE drum. |
|
Storage: |
Stored in a clean, cool, dry area; keep away from moisture and strong, direct light/heat |
|
Shelf Life: |
5 years if sealed and store away from direct sun light. |
