appearance

white or almost white powder

solubility

freely soluble in methylene chloride soluble in acetone and in methanol .sparingly soluble in hexane and in water

identification

ir

hplc

melting range

198~203℃

water

≤0.2%

residue on ignition

≤0.1%

heavy metals

≤200ppm

specific rotation

-187°~ -193°

related substance

7-hydroxymethyldrospirenone ≤0.1%

5-hydtoxydros- pirenone (at 195nm) ≤0.1%

17-ke1o drospirenone ≤0.1%

drospirenone 6-enen≤0.1%

drospirenone related compound a≤0.1%

6,7-epidrospirenone ≤0.1%

6,7-desmethylence drospirenone ≤0.1%

15-methy drospirenone ≤0.1%

7-methylence drospirenone ≤0.1%

7-methylence 17- drospirenone ≤0.1%

7-hydroxymethyl3,5(6)-diene drospirenone ≤0.1%

any unspecified impurity ≤0.1%

total impurities ≤0.4%

content

98.0%~102.0%

organic impurities

1,2-dimethoxyethane≤0.2%

disopyl other ≤0.1%

residual solvents

methanol≤3000ppm

methylene choride ≤600ppm

isopropyl ether≤1000ppm

terahydroluran≤720ppm

isopropyl scelate≤5000ppm

tnethylamine ≤320ppm

pycidine≤200ppm