[60]Fullerene for Medicinal Purposes, A Purity Criterion towards Regulatory Considerations

Since the early nineties countless publications have reported promising medicinal applications for [60]fullerene (C(60)) related to its unparalleled affinity towards free radicals. Yet, until now no officially approved C(60)-based drug has reached the market, notably because of the alleged dangers of C(60). Nevertheless, since the publication of the effects of C(60) on the lifespan of rodents, a myriad of companies started selling C(60) worldwide for human consumption without any approved clinical trial. Nowadays, several independent teams have confirmed the safety of pure C(60) while demonstrating that previously observed toxicity was due to impurities present in the used samples. However, a purity criterion for C(60) samples is still lacking and there are no regulatory recommendations on this subject. In order to avoid a public health issue and for regulatory considerations, a quality-testing strategy is urgently needed. Here we have evaluated several analytical tools to verify the purity of commercially available C(60) samples. Our data clearly show that differential scanning calorimetry is the best candidate to establish a purity criterion based on the sc-fcc transition of a C(60) sample (T(onset) ≥ 258 K, ∆(sc-fcc)H ≥ 8 J g(−1)).