Product Name

KETOCONAZOLE

Batch No.

20220105

MFG. Date

Jan.05, 2022

Quantity

1kg

Exp. Date

Jan.04, 2024

ITEMS

SPECIFICATIONS

RESULTS

Appearance

Off white powder or crystalline powder

Conform

Identification

IR test

Conform

Specific rotation

-1°~ +1°

0°

Melting range

148℃-152℃

148.0℃-149.9℃

Loss on drying

≤0.5%

0.04%

Residue on ignition

≤0.1%

0.03%

Heavy metals

≤0.002%

＜0.001%

Chromatographic purity

≤2%

Conform

Assay

98.0%-102.0%

99.8%

Organic volatile impurities

A: Ethanol

≤0.5%

＜0.5%

B: Ethyl Acetate

≤0.2%

＜0.2%

C: Dichloromethane

≤0.006%

＜0.006%

Conclusion

Conform to USP 32