Quality and Safety: Laboratory Testing at Chemnovatic

Laboratory testing is a key element in the manufacturing process, as it ensures that products comply with certain quality, safety and regulatory compliance standards.

In the area of chemical and pharmaceutical production, such as in the production of nicotine, these tests not only control the quality of raw materials and finished products, but also play a fundamental role in protecting consumer health and ensuring compliance with strict standards. This article will discuss various aspects of laboratory testing, its importance in terms of quality and safety, and the guidelines that govern these processes.

Previous blog articles have addressed compliance with legal requirements and regulations, the essence of the validation procedure, or maintaining appropriate environmental parameters. Links to those articles can be found below:

• Technical documentation of chemical products – what do you need to know?
• Reliability and purity: investigating trace substances in pure nicotine
• 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

Another area worth knowing and understanding is the laboratory. Chemnovatic has its own laboratory equipped with top-quality measuring equipment. This makes it possible to control the product during the manufacturing process, as well as test the final version.

In this article you will learn:

• what is the importance of well-conducted laboratory tests?
• where does the need for testing come from?
• what types of tests are carried out?
• what are the different methods based on?
• what is the importance of accurately weighing samples in laboratory tests?
• what precautions should be taken in the laboratory?

Laboratory testing is an extremely important element in the entire production process for several reasons:

Conducting appropriate laboratory tests ensures that the highest quality products are maintained at every stage of their manufacture. These tests assess the purity of the raw materials and the final product, analyze the chemical composition and determine the physical and chemical properties, which ensures that the final product meets all required quality standards.

Testing products for contaminants and substances harmful to the body is necessary to ensure the safety of both users and workers. Regular laboratory testing can detect and eliminate potentially hazardous substances that may be present in raw materials, semi-finished or finished products.

In this way, negative health effects that may result from contact with toxic chemicals, allergens or other harmful substances can be prevented.

The manufacturing process involves not only the manufacture of the product itself, but also compliance with the stringent requirements set by pharmacopoeial standards. Conducting laboratory tests helps ensure that products meet all required quality and safety standards. The above procedure provides a guarantee that chemical products are safe for consumers.

Laboratory tests are an essential tool in improving existing products and developing new ones. They make it possible to optimize the composition and properties of products and identify potential problems.

Obtaining the desired final product requires laboratory testing during the production process. For example, during nicotine distillation, a sample is taken and tested for water content and clarity. This helps ensure that the process is occurring correctly.

Regular testing makes it possible to quickly detect and correct any deviations from the norm. As a result, they ensure high quality and that the product meets the required standards.

The need for testing stems from several aspects. On the one hand are the company’s internal regulations, which define the standards by which the production process should be carried out in order to maintain the highest quality of the product. On the other hand, there are the requirements set by pharmacopoeial standards, which strictly define what tests and how they should be carried out to ensure compliance.

The stringent quality requirements for chemicals are set by two standards: The European Pharmacopoeia (EP) and the United States Pharmacopoeia (USP). Both pharmacopoeias aim to ensure the high quality, safety and efficacy of chemicals used in pharmacy, so acting in accordance with strict requirements is key to maintaining the highest quality and safety for customers.

These documents describe in detail the testing methods used in specific laboratory tests, and all laboratory tests are carried out in accordance with these guidelines, which is particularly important in terms of proper testing.

Learn more:

• CLP Regulation Changes In 2024: What You Need To Know?
• Pharmaceutical Quality Of E-Liquids: What You Should Know?
• E-Liquid Industry Regulations: REACH and CLP
• Main Chemical Regulations in the EU

Pharmacopoeia requirements are primarily applied to testing for nicotine, since it is a substance used in the pharmaceutical industry. In contrast, these requirements do not apply to nicotine bases, which are already a secondary product. However, this does not mean that they are not tested in any way. Products not subject to pharmacopoeial regulations are tested based on the company’s internal regulations.

The samples that are tested in the laboratory come from 4 sources:

Samples from production are described in such a way that they can be uniquely identified and the route they have taken can be reconstructed, making it possible to inspect any stage of their production process in the event of a discrepancy. Each sample is properly labeled and then tested and reported. The release of a batch of product for further stages of production (in the case of raw material) or for confection (in the case of finished product) can take place only after the results have been obtained in accordance with pharmacopoeial requirements or the requirements specified by the company’s internal document.

The same is true of samples from distillation lines. These are samples of nicotine distilled from the extract. The nicotine is tested both during and after the distillation process is completed, so the entire distillation process can be controlled.

Samples from the Research and Development Department are taken from raw materials that come from new sources. Each such raw material must be scrupulously tested before it is allowed into the production process. Such measures allow optimal selection of raw materials from suppliers for further production.

Samples provided by customers are also tested. As a rule, these are nicotine products, although not necessarily. Chemnovatic Laboratory offers a wide range of laboratory tests, ensuring quality service and customer satisfaction.

Pharmacopoeial monographs precisely define the scope of tests that must be performed on collected samples. All laboratory tests are carried out according to the strict guidelines of the pharmacopoeias, and any interference with the procedure must be justified. This ensures reliability, consistency, safety and compliance with industry regulations and standards.

In the case of chemicals, it is necessary to perform qualitative tests (identification, confirmation of the identity of the substance) and quantitative tests to determine such parameters as the content of the substance, the level of water and the type and content of impurities. Below is a brief description of the methods used in the Chemnovatic laboratory.

At our Chemnovatic laboratory, we place great importance on the quality and accuracy of our testing, which makes us a reliable and trusted partner in the industry. Every step of the testing process is carefully planned and executed in accordance with the latest standards and norms to ensure the highest accuracy and reliability of results. Below are the laboratory methods we use to meet these requirements and deliver the highest level of service to our customers.

This is a method used to determine the content of a given substance in a test sample. For example, it can be a test of the level of nicotine in nicotine – if the level comes out too low, it means that there are too many impurities in the sample. This method is fast, simple and does not require having an analytical standard of the substance under test. However, it does not allow the exact determination of the substances that constitute the contaminant. At the Chemnovatic laboratory, the potentiometric titration method is routinely used to determine nicotine content in nicotine salts, dilutions and e-liquids.

It is worth mentioning that when testing pure nicotine, the potentiometric titration method is not necessarily the “first choice” method when it comes to determining the content of the substance in the test sample. For example, the European Pharmacopoeia still requires the use of this method for testing the nicotine content of nicotine, while the U.S. Pharmacopoeia deleted titration from the nicotine monograph and replaced it with a chromatographic method. Because of these differences in the guidelines, both analytical methods must be used to meet the requirements of the two pharmacopoeias.

This is a titration method used to accurately determine the water content of test samples. Water is a very important element that affects the quality of the final product. Too much of it adversely affects the physicochemical properties and stability during the storage period of the product. Therefore, the water level is also checked during the distillation of nicotine, so that it can be controlled and, in case of excess, counteracted accordingly.

The process is also repeated after distillation is complete, when a sample is taken and tested using the same method to determine the water level in the final product. Determination of water content is also very important for nicotine salts, especially nicotine dihydrate, which is subject to pharmacopoeial requirements.

Gas and liquid chromatography are analytical methods that allow us to perform both qualitative and quantitative analysis. With these laboratory tests, we can not only determine the content of impurities in a substance, but also identify specific impurities. These methods are selective, meaning that the analysis separates the mixture into its individual components. As a result, we obtain a separate signal for each of these substances, which makes it possible to identify the components, as well as to calculate their content in the test sample (provided we have a suitable analytical standard).

Chromatographic methods are much more expensive and complex than potentiometric titration, while they allow the determination of substances at very low levels, down to 1 millionth of a gram per milliliter of sample (so-called trace analysis).

Pharmacopoeial guidelines also indicate that a substance must be identified. One way to identify a substance is to measure the specific rotation, that is the value of the rotation angle of the plane of polarized light. This is a characteristic of a substance under certain conditions (wavelength of light, temperature of measurement), which allows its unambiguous identification. It is not a universal method, since not all substances exhibit optical activity. In the Chemnovatic laboratory, this method is used to confirm the identity of nicotine and nicotine dihydrate.

According to pharmacopoeial guidelines, the identity of a substance must be confirmed by more than one analytical method. Chemnovatic Laboratory uses Fourier-transform infrared spectroscopy (FT-IR) for this purpose. This is a spectroscopic technique that is used to identify and characterize chemical compounds based on their spectrum in the infrared range.

The image of the spectrum is a characteristic peculiar to a substance, resulting from the type of bonds in the structure of its molecule. The collected spectrum is compared with the spectrum obtained for the pharmacopoeial standard of the substance under study, if the degree of matching (similarity) of the two spectra is high enough, we can conclude that the substance under study is identical to the standard.

The FT-IR method is used in the Chemnovatic laboratory to confirm the identity of nicotine, nicotine dihydrate, glycerol and propylene glycol.

The method of testing identity with a refractometer involves determining the refractive index of a substance or its solution. Under certain measurement conditions (temperature and light wavelength), this coefficient is characteristic of the substance. This method is used in the Chemnovatic laboratory to confirm the identity of glycerin. Thanks to the use of a modern digital refractometer, the laboratory is able to provide a result with very high accuracy in a short time.

Density is a parameter that is sometimes required pharmacopoeially, but is sometimes needed in determining the properties of dilutions. It is a test often requested by customers because density is one of the key determinants of product quality, especially in the context of dilutions and liquids. The Chemnovatic laboratory has an advanced digital densitometer that can measure density to an accuracy of one ten-thousandth of a gram per cubic centimeter. Such high measurement accuracy is essential to ensure that products meet stringent quality standards and regulatory requirements.

The pH coefficient is a crucial quality indicator for snus-type samples provided by customers. The laboratory is equipped with a modern pH meter that allows potentiometric pH measurements, resulting in very high measurement accuracy. The device is regularly calibrated using certified reagents (buffers), ensuring that the measurements meet the highest standards of accuracy.

The accuracy of sample weighing before actual testing is essential because slight deviations can significantly affect the test results. Specialized analytical balances are used for weighing, which must be operated under appropriate conditions. These balances are sensitive to movement, drafts, temperature changes, and humidity, so they operate in a separate room where these parameters are strictly controlled. This ensures that samples are weighed with great precision, leading to accurate laboratory tests. Therefore, it is also important to regularly check the calibration and operation of the balances to ensure the highest production quality. Chemnovatic Laboratory has a balance with a reading accuracy of up to one-hundredth of a milligram.

Working in a laboratory involves constant contact with chemicals, such as pure nicotine, which can pose health or even life-threatening risks. Therefore, it is very important to follow all safety precautions to minimize the risk of potential hazards. There are several basic rules to which particular attention should be paid:

When working with chemicals, it is crucial to prevent any hazards that may be caused by these substances. It is important to remember that chemicals can enter the body in various ways, so protective clothing should provide protection against solid, liquid, and airborne substances. For this purpose, it is necessary to wear special lab coats, gloves, goggles, and masks that protect the body from the harmful effects of hazardous substances.

Maintaining proper hygiene is also essential when working in the laboratory. Thorough hand disinfection before and after work prevents the risk of contamination and excessive exposure to harmful substances. Additionally, eating and drinking are prohibited in the laboratory, as this can lead to the ingestion of harmful substances. Meals should be consumed outside the laboratory area, in designated places intended for this purpose.

Special attention must be paid to the proper storage of chemicals in the laboratory to ensure safety and avoid hazards. Chemicals should be stored in appropriate containers, labeled with information about their properties and hazards. All relevant information is available in Material Safety Data Sheets (MSDS) and technical sheets, which laboratory staff must have access to. In the event of spills or leaks, proper emergency procedures should be followed. Regular staff training and storage audits help maintain high safety standards in the laboratory.

In case of contact with hazardous substances, quick response is crucial. Knowledge of first aid procedures can save lives in emergencies before professional medical help arrives. Employees must be properly trained to handle various injuries resulting from contact with chemicals. Access to necessary personal protective equipment, such as gloves and safety goggles, should also be ensured. Regular drills and procedure updates help maintain a high level of readiness in case of an accident involving hazardous substances.

1. Well-conducted laboratory tests are crucial for ensuring the quality, safety, and compliance of chemical and pharmaceutical products.

2. The requirement to conduct tests arises from internal company regulations and pharmacopoeial standards, such as the European Pharmacopoeia (EP) and the United States Pharmacopoeia (USP), which specify testing methods and quality standards. The tests are not only compliant with pharmacopoeial standards but also with internal regulations.

3. Samples for laboratory testing come from various sources: production, the distillation line, the R&D Department, and customers.

4. Laboratory tests utilize various methods:

• Potentiometric titration: Used to determine the quantity of a substance, although not for identifying impurities.
• Karl Fischer method: For precise and accurate measurement of water content in samples.
• Gas and liquid chromatography: For qualitative and quantitative analysis, as well as impurity identification.
• Method of testing the specific rotation of polarized light: For identifying substances based on their effect on polarized light.
• FT-IR (Fourier Transform Infrared) method: For identifying chemical compounds based on their infrared spectrum.
• Refractometry method: For identifying substances by determining the refractive index of a substance or its solution.
• Density: A test often requested by customers, as density is a key quality indicator, especially in the context of dilutions and liquids.
• pH meter: pH meter testing is used for snus-type samples provided by customers

5. Accurate sample weighing is key to obtaining reliable test results. Balances must be calibrated and used under controlled conditions to avoid measurement errors.

6. Laboratory safety is ensured by using appropriate protective clothing, maintaining high hygiene standards, proper chemical storage, and knowing first aid procedures.

Conducting laboratory tests in the chemical industry is an integral part of implementing ESG strategies. These tests allow companies to monitor and reduce their environmental impact, ensure user safety and health, and support regulatory compliance and transparency. This enables companies to better manage risk, improve their environmental and social performance, and build lasting relationships with stakeholders, ultimately supporting their sustainable development and long-term success.

Don’t risk the quality and safety of your products. Take advantage of professional laboratory testing that ensures compliance with the highest industry standards. Trust the experts and ensure your products meet the highest quality. Use the services of our Chemnovatic Laboratory and entrust us with the testing of your products!

Chemnovatic has a team of qualified professionals who provide comprehensive legal support and help navigate all the guidelines and standards related to the chemical industry. Discover new growth opportunities for your business by joining our satisfied customers. Together, we will achieve success!

Learn more about our services here or contact us directly at sales@chemnovatic.com to maximize your business success.

• E-Liquid Manufacturing: Employees Safety and Well-being
• Chemical Storage Best Practices in E-Liquid Manufacturing: A Comprehensive Guide
• “We are committed to sustainable consumption”: Sustainability In The Chemical Industry
• E-Liquid Manufacturer Standards: Practical Tips For Producers And Brand Owners
• Safe Usage Of Chemicals: Chemnovatic Guide