ITEMS

SPECIFICATION

Appearance

White To Off White Powder

Identification

A) IR Spectrum Conforms To Drospirenone RS

B) Rt HPLC Conforms To Drospirenone RS

Melting point

198-203

Specific rotation

(10mg/ml in methanol)

-186°to -196°

Water

≤0.2%

Heavy metals

≤20ppm

Chromatographic Purity

Individual impurity ≤0.1%

Total impurities ≤0.4%

Residue On Ignition

≤0.1%

Assay (HPLC)

98.0%-102%

(Calculated On The Anhydrous Basis)

Residual Solvents

1.2-dimethoxyethane≤0.2%

diisopropyl ether≤0.1%