Polidocanol

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Cat Number

API0232178

CAS Number

3055-99-0

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Product Detail Description Scientific Support Customer Q&A

CAS Number

3055-99-0

EINECS

221-284-4

Storage

Store at room temperature

Synonyms

Nonaethylene glycol monododecyl ether; Asclera; Aethoxy-sklerol; nonaethylene glycol monolauryl ether; VARITHENA

Molecular Formula

C30H62O10

Molecular Weight

582.8

Smiles

CCCCCCCCCCCCOCCOCCOCCOCCOCCOCCOCCOCCOCCO

Appearance

Clear oily liquid

Melting Point

41-45°C

Boiling Point

615.9±50.0°C at 760 mmHg

Relative Density

1.0±0.1

General Description

Polidocanol is a synthetic non-ionic surfactant composed of a hydrocarbon chain (lauryl alcohol) polymerized with ethylene oxide units (polyethylene glycol). Its structure is a polyethylene glycol ether of dodecanol, with an average of 9 ethylene oxide units. Polidocanol is a colorless to pale yellow viscous liquid with a mild characteristic odor and is miscible with water and organic solvents.

Mechanism of Action

Polidocanol acts as a sclerosing agent by disrupting the lipid bilayer of the endothelial cell membrane of veins upon contact, causing denaturation of proteins and cell lysis. This results in a localized inflammatory response and subsequent fibrosis, leading to obliteration of the vessel lumen. The surfactant action is concentration-dependent, with higher concentrations causing more rapid and complete endothelial damage.

Application

Polidocanol is indicated as a sclerosing agent for the treatment of varicose veins and spider veins (telangiectasia) of the lower extremities. It is also used as a local anesthetic in the form of Aethoxysklerol for endovenous procedures. The drug is effective in both liquid and foam formulations, with the foam providing better displacement of blood and greater surface contact.

In rhesus macaques and baboons, intrauterine infusion of 5% polidocanol foam (PF) produced tubal occlusion with fibrosis and collagen deposition (Col-I, Col-III, Col-IV, Col-V) in the intramural fallopian tube, with no epithelial damage in the isthmus or ampulla. Controls showed normal epithelium without Col-I staining. PF-induced tubal blockage results in lasting collagen-rich obstructions, supporting further development of PF as a nonsurgical permanent contraceptive.

Fig. 1 Photographs showing Col-I, Col-II, Col-IV and Col-V staining in rhesus macaque ampulla. (Slayden OD, et al., 2016)

References

Slayden OD, et al. Polidocanol induced tubal occlusion in nonhuman primates: immunohistochemical detection of collagen I-V. Contraception. 2016;94(5):521-526.

Does Polidocanol require protection from light and oxygen during storage?

Yes, it is sensitive to light and oxidation, which can cause peroxide formation and degradation. Store in light-resistant, airtight containers under inert gas.

What is the recommended storage temperature for Polidocanol?

Store at controlled room temperature (15-25°C). Avoid excessive heat above 30°C, which can accelerate oxidation and volatile loss.

Is Polidocanol stable in solution for sclerotherapy use?

Aqueous solutions are stable when protected from light and stored at room temperature.

How is the peroxide impurity (oxidation product) monitored?

Peroxide value is measured using a validated titrimetric method, ensuring it remains within pharmacopoeial limits.