Issue link: https://read.dmtmag.com/i/1545684
50 tobaccoasia Issue 4, 2026 July / August fractional separation, and proprietary advanced purification technologies," all conducted under stringent GMP conditions. Nicobrand, in conjunction with its parent company CNT, have their own dedicated nicotine extraction facility in India, meaning that all po- tential impurities of nicotine are tightly controlled right from leaf extraction through to its final purification at its cGMP facilities in Northern Ireland and Switzerland. The technical challenge lies in the chemical similarity between nicotine and many of its impurities. As Płaska explained: "Purification cannot rely on a single step only," but demands a carefully orchestrated sequence of processes, each designed to remove specific compounds without compromising the integrity of the nicotine itself. The pursuit of purity—and its limits While pharmaceutical standards define acceptable impurity thresholds, leading manufac- turers often exceed these requirements. For example, Chemnovatic reported achiev- ing impurity levels "significantly below USP/EP limits," with total impurities in some cases falling below 0.01%. However, absolute purity is not always the ultimate goal. The more important objective is to achieve the right balance between pharmacopeial compliance, sensory performance, and batch consistency. This requires not only high-purity nicotine pro- duction to begin with, but also experience in how nicotine behaves in real formula- tions, such as e-liquids and nicotine pouches, where even trace impurities can influence sensory perception, odor profile, and overall formulation performance. According to Tomasz Płaska, this is addressed by Chemnovatic's four-step quality verification system, covering in-process laboratory analysis, finished product laboratory testing, sensory assessment of each batch and final batch release based on complete analytical and quality documentation. Alchem has taken this concept still further with its proprietary NOTES© sys- tem, which uses AI-driven analysis to evaluate and control organoleptic properties at parts-per-million (ppm) and parts-per-billion (ppb) levels. This allows the company to deliver what Balconi described as "one of the cleanest, purest, most stable and sensory- neutral nicotine available." From Nicobrand's perspective, McQuillan highlighted the benefit of having worked with stringent regulatory healthcare bodies for decades, where demands go much further than just a Certificate of Analysis, culminating in Nicobrand's/CNT's products "always falling below any detectable limits for impurities." Why purity matters across product categories The importance of pharmaceutical-grade nicotine varies depending on the end product, but its relevance is expanding across the board. In traditional nicotine replacement therapies (NRT)—such as patches, gums, lozenges, and inhalers—pharmaceutical- grade nicotine is effectively mandatory. These products are regulated as medicines, re- quiring strict adherence to pharmacopeial standards and GMP manufacturing. On the other hand, for consumer products like e-liquids, nicotine pouches, and heated tobacco, the regulatory pic- ture is more fragmented. "It depends pri- marily on the product category, not only on geography," Płaska explained. While the European Union requires "high- purity ingredients" under its Tobacco Products Directive (TPD), it does not explicitly mandate pharmaceutical-grade nicotine for all products. Nevertheless, Nicobrand's Mark McQuillan argued that the RRP industry should consider a standard at least akin to medicinal nicotine, given the wider pro- liferation of these products. "The safest pitch is to say you should use a pharma- ceutical-grade nicotine," he stated, citing the "exemplary safety record of patches, gums, and lozenges for over 30 years" - incidentally using nicotine from Nico- brand/CNT." This historical pedigree provides reassurance not only to regu- lators but also to consumers, many of whom still misunderstand nicotine's role in tobacco-related harm. Risks of lower-grade nicotine Using non-pharmaceutical-grade nicotine introduces a range of risks, from sensory inconsistencies to regulatory non-com- pliance. Alchem's Anna Balconi warned that apart from unpredictable product behavior, such materials may lead to "daily exposure to potentially harmful levels of toxic impurities." Tomasz Płaska, Chemnovatic. Credit: Chemnovatic Nicotine distillation setup at Chemnovatic. Credit: Chemnovatic