ITEMS

SPECIFICATION

RESULTS

Description

White or pale yellow powder

White powder

Identification

A:IR

B: The retention time of the major peak of the Sample solution corresponds to that the Standard solution, as obtained in the Assay.

Complies

Optical Rotation

+15.0°to +25.0°

+22.1°

Water Determination

NMT0.50%

0.28%

Organic Impurities,

Procedure 1

Dutasteride acid^a(RRT0.10)≤0.2%

N.D

Dutasteride dimethylamide^b(RRT0.11)≤0.2%

0.01%

Dutasteride methylester^C (RRT0.28)≤0.15%

0.01%

Dutasteride ethyl ester^D (RRT0.39) ≤0.2%

N.D

Dutasteride 17a-5-ene^e(RRT0.90)≤0.2%

0.02%

Dutasteride 17a-epimer(RRT0.93)≤0.3%

0.03%

Chlorodutasteride^f(RRT1.15)≤0.4%

0.03%

Dutasteride 5-ene^g (RRT1.20) ≤0.3%

N.D

Any other individual impurity ≤0.1%

0.07%

Organic Impurities

Procedure 2

Dihydrodutasteride^a(RRT1.19)≤0.15%

0.01%

Dutasteride a-dimer(RRT3.7)≤0.3%

N.D

Dutasteride β-dimer(RRT4.3)≤0.5%

N.D

Any other individual impurity≤0.1%

0.01%

Total impurities^b ≤2.0%

0.22%

Assay(based on drying)

NLT 97.0% and NMT 102.0% of dutasteride

99.9%

Residue on ignition

Max.0.1%

Complies

Residual Solvents  (GC):

Acetonitrile N.m.t.3000ppm

N.D

Ethyl acetate N.m.t.2000ppm

603PPM

Dioxane N.m.t.1000ppm

N.D

n-Heptane N.m.t.5000ppm

N.D

Pyridine N.m.t.2000ppm

N.D

Toluene N.m.t.2000ppm

N.D

Conclusion: The product complies with USP40

Storage condition: Room temperature ,in a closed container.