Abstract: Most commercially available nicotine is the S isomer derived from tobacco. All tobacco derived nicotine (TDN) products are regulated by the FDA as drugs or tobacco products. Synthetic nicotine (SynNic) products were not previously regulated but are now regulated by the FDA as a tobacco product. Depending on the manufacturing process, SynNic can be produced as a racemic mixture of R and S nicotine or predominantly S nicotine. TDN can be differentiated from SynNic by radiocarbon dating. TDN is >99% S-isomer. The amount of S-isomer in SynNic can be used to determine if the synthetic version is equivalent to the tobacco derived version. Not all SynNic is >99% S-isomer. The SynNic from CNT is equivalent to the TDN, also being composed of >99% S- isomer and also highly exceeding all USP requirements as well as the European Pharmacopoeia (Ph. Eur.) requirements.

Ed Carmines, Bryan Burd, Kevin Burd

Affiliations: Chemular Inc, Hudson MI, USA

 

 

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