Improper Potency and Impurities in Compounded Polidocanol

November 2019 | Volume 18 | Issue 11 | Original Article | 1124 | Copyright © November 2019

Margaret Mann MD,a Gilly S. Munavalli MD,b Lisa Amatangelo MD,c and Nick Morrison MDd

aInnova Dermatology, Hendersonville, TN bDermatology, Laser & Vein Specialists of the Carolinas, Charlotte, NC cWeill Cornell Vein Treatment Center, New York, NY dCenter for Vein Restoration, Mesa, AZ

As compounded polidocanol for the treatment of varicose veins continues to be available from several pharmacies and outsourcing facilities in the United States, the objective of this study was to obtain and analyze samples of compounded polidocanol for potency and purity.


Seven samples of polidocanol were purchased from three compounding pharmacies. Labeled concentrations of polidocanol ranged from 1.5% to 5%. Each sample was analyzed for potency of lauromacrogol 400 (polidocanol) and purity with reversed phase high pressure liquid chromatography (HPLC) with refractive index (RI) detection (Chemische Fabrik Kreussler & Co. GmbH, Wiesbaden, Germany). The results were compared with an FDA-approved polidocanol product (Asclera® Injection, Merz North America, Raleigh NC).


Results of the analysis are summarized in Table 1. Among the seven samples analyzed, six were sub-potent, containing 65.8 to 91.4% of the labeled concentration, and one was super-potent, containing 108.7% of the labeled concentration. Five contained a 10-fold excess of foreign fatty alcohol ethoxylate impurities and four exceeded the limit for unknown impurities. Overall, none of the tested samples were equivalent to the commercially marketed, FDA-approved product (Asclera) with respect to potency and purity.


Similar to previous studies,12,13 compounded polidocanol solutions did not deliver the claimed potency in six of seven tested samples and five samples contained excessive contaminants. This inconsistency poses unacceptable risks, most importantly to the patient, but also medicolegal risks to the treating physician. In contrast, clinical trials have demonstrated FDA-approved polidocanol provides effective treatment of chronic venous insufficiency with low toxicity, minimal risk and few complications.21

Contaminants found in the tested compounded polidocanol samples in several publications included foreign fatty C-14 alcohol ethoxylate impurities, excessive formaldehyde and unknown impurities. Other reported contaminants in compounded sclerosants include carbitol,12 tetradecanol, several isomers of 7-ethyl-2-methyl-undec-3/4 ene,14 chlorobutanol (trichloro-2- methyl-2-propanol), benzaldehyde, and benzyl alcohol13 (some samples contained multiple contaminants). Together, these results indicate the lack of purity of the ingredients and/or the absence of sufficient manufacturing controls used to compound these products.

In addition to frequently not meeting the labeled ingredient specifications for potency and purity, there is no requirement for compounded product labeling to include an approved shelf life. If the compounded product is not immediately used, there is no assurance that the product will remain potent and efficacious.