PRODUCT NAME:

TESTOSTRONE UNDECANOATE

BATCH NO

1809001

MFG DATE

2018/09/02

EXP DATE

2021/09/01

TEST ITEMS

 SPECIFICATION

RESULTS

Description

White or Almost White Crystalline Powder

White Powder

Solubility

Free soluble in Chloroform,soluble in Ethanol,sparingly soluble in Methanol and Vegitable oil.insoluble in water.

Conforms

Identification

1)Sulforic acid & Ethanol Solution

Positive

2)HPLC with RS

Positive

3)IR

Positive

Assay

97.0~103.0%

99.56%

Specific Rotation

+68~+72℃

+69.9°

Loss On Drying

0.5%max

0.22%

Melting Point

60~63℃

60.5~62.5°C

Related Substances

Individual Impurity:0.5%max

0.20%

Total Impurities:2.0%max

0.70%

Testosterone:0.5%max

0.20%

Testosterone Decanoate:0.5%max

Undectable

Residual Solvents

Ethanol:5000ppm max

<500ppm

Acetone:5000ppm max

Undectable

N-Hexane:290ppm max

Undectable

Isopropyl Ether:1500ppm max

Undectable

Toluene:890ppm max

<200ppm

Pyridine:200ppm max

<100ppm

Methanol:3000ppm max

<500ppm

Conclusion

The specification conform with enterprise standard