Reliability and purity: investigating trace substances in pure nicotine

Quality assurance in the vape industry is not only a matter of selecting the best ingredients, but also ensuring that they comply with rigorous standards. In this context, the USP (United States Pharmacopeia) and EP (European Pharmacopeia) standards are becoming key documents for any business owner in this industry. They are responsible for determining not only the composition and testing methods of substances, but also provide information on their purity and safety.

In the process of distilling naturally occurring nicotine from tobacco, unfortunately, some impurities are inevitable. Nevertheless, our PureNic 99+ nicotine meets the stringent requirements set by the USP/EP, containing only a fraction of a percent of permitted foreign substances. The standards specify that the allowable water content is 0.5%, and in our PureNic 99+ nicotine it is only 0.05%. So we can confidently say that our product has almost 100% purity.

Based on the type and source of the impurity, we can divide it into two groups. These are specific impurities and non-specific impurities.

Specific impurities are also referred to as degradation impurities. These are certain by-product compounds that can be formed during the processing of a substance or the decomposition of a substance due to storage under unsuitable conditions, i.e. exposure to excessive sunlight and storage at the wrong temperature and humidity. In the case of the distillation of natural nicotine, these by-product compounds are simply its derivatives.

Non-specific impurities are otherwise known as production contaminants, which originate in the raw materials and solvents used in the production process, but also in the production apparatus and premises. They can include a variety of chemicals, dusts, microorganisms or by-products of industrial processes. Due to the fact that such contaminants come from many different places it is sometimes difficult to determine their exact source. For this reason, it is also worthwhile to ensure the cleanliness of the entire production environment to minimize the amount of non-specific pollution.

It is worth noting that impurities may have no effect on the performance of the substance being produced or may have a similar and sometimes even pharmacologically more favorable effect on the active substance. On the other hand, they may not have a harmful effect on the body.

For PureNic 99+, the specific impurities are nicotine derivatives, these are the 7 compounds listed below.

• Impurity A – Anatabin – Maximum 0.3%.
• Impurity B – Beta-nicotine – Maximum 0.3%
• Impurity C – Cotinine – Maximum 0.3 percent
• Impurity D – Myosmin – Maximum 0.3 percent
• Impurity E – Nicotin N’-oxide – Maximum 0.3 %
• Impurity F – Nornicotin – Maximum 0.3 %
• Impurity G – Anabasin – Maximum 0.3 %

On the other hand, a non-specific impurity is water, which is used as a solvent in the distillation process.

With checking the contamination level of a substance, it is worth mentioning such concepts as the limit of detection and the limit of quantification. They are crucial in performing precise laboratory testing of a substance.

The limit of detection is the smallest concentration of a test substance that can still be detected with an appropriate measuring device. Simply put, it is the point at which the test substance is barely noticeable but still detectable. Thanks to the detection limit, we know whether a pollutant is present in the sample under test, even in very low concentrations. This helps in assessing how harmful a substance may be.

The limit of quantification is the smallest amount of a substance that can be accurately measured and identified using a given analytical method. This means that once this limit is exceeded, we are able to determine exactly how much of a given substance is in the sample being tested. It is important for a quantitative indication of the level of contamination. It also gives information about whether a given analytical method is sensitive enough to accurately measure the concentration of a substance in a test sample.

Knowing the limit of detection and the limit of quantification allows a more precise and reliable assessment of the level of contaminants, which is crucial for protecting the health of those who come into contact with a substance, as well as for protecting the environment itself. It is important to remember that accurate laboratory testing of substances and raw materials used in the manufacture of tobacco products is key to ensuring the safety of individuals and the highest quality of the product.

The detection limit helps to identify the presence of contaminants and to assess the risk and decide whether to test the substance further, while the limit of quantification enables accurate reporting of the amount of contaminants, which is key to maintaining compliance with regulatory standards.

Nicotine can be extracted naturally or be synthesized from chemical components. In the case of synthetic nicotine, there are indeed no impurities, but it is a very expensive process to obtain, and its quality is not necessarily superior to that of natural nicotine.

PureNic 99+ natural nicotine is extracted by distilling high-quality extracts obtained from properly selected tobacco leaves. Ensuring an appropriate production environment, repeatability of production processes and the highest quality raw materials affect the final quality of distilled nicotine. As a result, it meets the requirements of pharmacopoeias, and its purity is 99.5%.

It is worth noting that the purity of nicotine does not mean the complete absence of impurities, only the amount of impurities that does not exceed the permitted content specified by the USP/EP guidelines. This is related to the limits of detection and quantification described earlier.

On the market, you may encounter “no impurities” terms, which may suggest that the product offered by the manufacturer is completely free of impurities. It is worth noting this and remembering that the impurities present in natural nicotine are the result of the distillation process, and although their amount is trace, to speak of their absence is somewhat misleading.

When choosing raw materials and substances for production, it is always a good idea to do some prior research and check whether they meet the appropriate standards and have quality certificates. Attention to product quality is important on both the manufacturer and customer side. The manufacturer builds reputation and customer loyalty, while the customer gains satisfaction with the product and a sense of security. This approach leads to long-term cooperation and market success.

As a company that has been involved in the production of nicotine for years, we know well how important it is to maintain the highest quality of the product. By enlisting our help in complying with the strictures of regulations and pharmacopeial standards, you will be able to provide your customers with the highest quality products.

Find out more about regulatory services here or contact us directly via sales@chemnovatic.com to ensure your company’s good reputation.

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• Pharmaceutical Quality Of E-Liquids: What You Should Know?
• Hard To Handle, Easy To Vape – A Thing About Safe Work With Nicotine
• Synthetic Nicotine vs. Tobacco Nicotine
• REACH and CLP Summary on the Example of PureNic 99+ Pure Nicotine
• Nicotine: What It Is And How Is It Classified?
• Nicotine & Vape Guides For E-Liquid Brand Owners
• Technical documentation of chemical products – what do you need to know?
• Production environment – the essence of the validation procedure in maintaining the highest quality products 
• How to maintain quality in the chemical industry: the key role of parameter control in the production environment