Ketoconazole

Items

Specification

Results

Appearance

White or almost white crystalline powder

confirms

Identification

IR

Confirms

Melting range, °C

148.0~152.0

148.0~150.

Specific Rotation

-1.0o~+1.0o

0o

Loss on Drying, %

≤ 0.50

0.1

Residue on Ignition, %

≤ 0.10

0.06

Heavy Metals, %

≤ 0.002

< 0.002

Chromatographic purity, %

≤ 2.0

Confirms

Residue Solvent, %

Acetoacetate

≤ 0.50

0.3

Dimethyl sulfoxide

≤ 0.50

0.2

Bacteria

Not more than 10 per g

Confirms

Mold & yeast

None-detected

Confirms

Assay, %

98.0~102.0

99.2