Issue link: https://read.dmtmag.com/i/1545684
Tobacco Asia 49 During a separate interview with Tobacco Asia, Anna Balconi, technical and regulatory manager at Alchem NicSelect, echoed Płaska's view, emphasizing that such nicotine is "purified, standardized, and manufactured under strict GMP con- ditions," ensuring it is suitable for both pharmaceutical applications and high- quality next generation products (NGP). In addition, Mark McQuillan, man- aging director of Nicobrand, pointed out that meeting these monographs is only the beginning. "Whilst meeting the monograph might be the basic entry level, the scrutiny goes much deeper," he noted, highlighting that extensive regulatory audits, testing above and be- yond the monographs and answering de- tailed technical requests, are required for nicotine to be used in licensed medicinal products. Pharmaceutical-grade nicotine is, therefore, not just a specification—it is a system encompassing manufacturing processes, regulatory filings, and long- term safety validation. From leaf to lab: The complexity of production The journey from raw tobacco leaf to pharmaceutical-grade nicotine is any- thing but straightforward. Tobacco, as a natural material, contains a vast array of compounds beyond nicotine itself. "Nicotine extracted from tobacco is not a 'clean single compound' at the beginning of the process," said Płaska. Alongside nicotine, tobacco contains other alkaloids such as nornicotine, anaba- sine, and anatabine, together with numerous other naturally occurring compounds, including carbohydrates, proteins, phenolics, and organic acids. Płaska emphasized that, in practice, the key is not only how these impurities are removed but also how the process is designed to prevent unwanted compounds from being carried forward between stages. Alchem's Anna Balconi expanded on this complexity, noting the presence of "tobacco-specific nitrosamines (TSNAs), residual solvents, trace metals, pesticides, and volatile organic compounds." These impurities may originate from soil conditions, agricultural inputs, curing processes, and even the extraction methods used. Removing these substances requires a sophisticated, multi-stage purification pro- cess. Chemnovatic employs a "controlled, multi-stage purification approach," combining extraction, distillation, and analytical verification. Alchem similarly relies on "distillation, Anna Balconi, Alchem. Credit: Alchem Alchem's STP in action in India. Credit: Alchem Alchem's manufacturing facility in Neemrana, India. Credit: Alchem