Quetiapine Fumarate

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:

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.