Nicotine

Smoking addiction and related chronic respiratory and cardiovascular diseases have become a prominent burden in the global public health field. As the core substance responsible for tobacco dependence, nicotine is also the key active pharmaceutical ingredient (API) of nicotine replacement therapy (NRT). It belongs to cholinergic alkaloids, and can bind to nicotinic acetylcholine receptors in the central nervous system to simulate the physiological effects of low-dose nicotine, alleviate withdrawal symptoms during smoking cessation, and reduce the risk of relapse. It is suitable for adult smokers with clear willingness to quit smoking, is the core component of first-line smoking cessation adjuvant drugs recommended by current clinical guidelines, and can also be used as a pesticide raw material for the preparation of agricultural insecticides.

The global nicotine API market size exceeded USD 870 million in 2023, and the compound annual growth rate from 2024 to 2030 is expected to remain at around 7.2%. The growth momentum mainly comes from the steady increase in demand for smoking cessation drugs and the rapid expansion of the supply chain of new tobacco products. At present, the global supply side presents a "dual-track pattern": the production concentration of pharmaceutical-grade nicotine is relatively high, with leading enterprises accounting for nearly 60% of the market share. India and China are the world's major nicotine producers and exporters. The domestic production approval threshold for pharmaceutical-grade nicotine is high, and the approved production capacity accounts for less than 15% of the total global production capacity, leading to a long-term gap between market supply and demand.

The original research of nicotine was first developed into a smoking cessation drug by Novartis, with the original brand name "Nicopatch". The core compound patent expired globally in 2008. At present, the main marketed dosage forms of the original research include patches (specifications: 7mg/14mg/21mg per 24 hours), chewing gums (specifications: 2mg/4mg), and lozenges (specifications: 1mg/2mg). Relevant dosage forms have been included in the FDA Reference Listed Drug Catalog and China's *Catalog of Reference Preparations for Chemical Drugs*. As of October 2024, 12 domestic enterprises have obtained CDE registration numbers (Status A) for their nicotine APIs, and domestic preparations such as nicotine chewing gums and patches have also been approved for marketing. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for nicotine API, covering all types of impurities involved in the synthesis and degradation processes. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can be directly used for API quality research, qualitative and quantitative analysis of impurities, and registration and declaration scenarios.