Fluconazole

ITEMS

SPECIFICATION

Appearance

White or almost white, hygroscople,  crystalline

powder

Solubility

Slightly soluble in water, freely soluble in methanol, soluble in acetone

Identification

Complies

Appearance of Solution

The resulting solution should be Clear and colorless

Related substances (%)

Impurity A ≤0.4%

Impurity B ≤0.3%

Impurity C ≤0.1%

Unspecified impurities ≤0.1%

Total impurity ≤0.6%

Heavy Metals

≤0.001%

Loss on Drying

≤0.5%

Sulphated Ash

≤0.1%

Assay (On Dry basis)

99.0～101.0%