Tibolone Description

Tibolones (CAS No.:  5630-53-5) is a synthetic hormone-type drug which is used mainly for hormone replacement therapy in post-menopausal women.  It is a synthetic steroid that has the same activity as the female sex hormones estrogen and progesterone and the androgen testosterone.  Tibolones helps restore hormonal balance in the body. 

Certificate of Analysis (COA)

TEST ITEMS

SPECIFICATION

RESULTS

Description

Light yellow or almost white crystalline powder

Light Yellow powder

Identification

IR

Positive

Assay

97.0~103.0%

99.37%

Melting Point

70~80°C

70.5~76.5°C

Specific Rotation

+22~+26°

+23.09°

Loss On Drying

0.5%max

0.25%

Residue On Ignition

0.1%max

0.05%

Heavy Metals

20PPm max

<20PPm

Organic Volatile Impurities

Meets the requirement. 

Conforms

Related Substances

Single Impurity: 1.0%max

<1.0%

Total Impurities: 2.0%max

<2.0%

Conclusion

The specification conforms to enterprise standard. 

Tibolone Application

Tibolone is used in the treatment of endometriosis and menopausal symptoms. It has similar or greater efficacy compared to older hormone replacement drugs, but shares a similar side effect profile. 

Tibolone has also been investigated as a possible treatment for female sexual dysfunction.