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Quetiapine Fumarate Manufacturing United Kingdom and USA
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Quetiapine Fumarate

  • Product Name : Quetiapine Fumarate
  • Grade : IP / BP / USP
  • Therapeutic Category : Antipsychotic
  • CAS No : 111974-72-2
  • COA : Available
  • MSDS : Available

Description

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.

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