Product name

Oxandrolone

Test Of Analysis

Standard Of Analysis

Results Of Analysis

Identification (TLC, IR)

HPLC, IR

Positive

Solubility

Practically insoluble in water;

Weakly soluble in chloroform;

Slightly soluble in ethanol.

Conforms

Melting Point

229-232 °C

230~232 °C

Loss On Drying

≤1.0%

0.32%

Residue On Ignition

≤0.2%

0.06%

Related substance

Impurity 1 2 4 5 6 8 10 ≤0.1%

Impurity 3 7 9 ≤0.3%

Impurity 11 ≤0.5%

Individual unknown impurity ≤0.1%

Total Impurities ≤1.0%

Conforms
Conforms
Conforms
Conforms
0.91%

Residual Solvents

Ethanol ≤1365 ppm

Methanol ≤3000 ppm

Conforms

Assay

98.0 ~ 102.0%

99.3%

Micronized

30 Mesh≥100%

Pass