Nicotine Product Testing

Inter Scientific is accredited to the international standard ISO/IEC 17025:2017 for the testing of nicotine containing products. For our full range of UKAS accredited testing, please view our UKAS Certificate Customer Number 21379.

Our expertise spans vape, oral nicotine and dermal nicotine products.

Areas of work

Our nicotine product testing capabilities

Our vape product testing services

Vape Products

Vape product testing requirements differ from region to region. Our laboratory is committed to providing the highest quality of scientific data across all regulatory regions.

Harmful and Potentially Harmful Constituent (HPHC) testing

Harmful and Potentially Harmful Constituents (HPHC) are a set of key analytes identified by the Food and Drug Administration (FDA) in the United States which are believed to impact of the safety of ENDS products and therefore play a key role in the determination of the Appropriateness for the Protection of Public Health (APPH) for vape products intended for marketing in the US. Inter Scientific offers a full suite of HPHC testing in accordance with FDA guidance. Analysis is performed to ISO 17025 and is covered on the company’s scope of accreditation. It is recommended to conduct HPHC testing on three (3) batches of each product, using seven (7) replicates. Further, it is recommended to conduct testing both under reasonable and foreseeable conditions and intense conditions in order to appropriately characterise product chemical safety.

Inter Scientific has vast experience in testing e-liquids, and vapour from both open and closed systems with data submitted to FDA. The company holds a Tobacco Product Master File for all HPHC methods which clients may reference within their PMTA/MRTPA or SE applications.

Particle Size & Spread

Using laser diffraction particle size and spread can be characterised in order to better understand the site of deposition of vape /ENDS products. This information plays a key role in determining the relative safety and effectiveness of nicotine delivery, based on the principle that larger particles are deposited higher up in the airway or mouth, leading to slower absorption. The use of a USP throat allows more accurate determination of particle size and spread to aid in the scientific understanding of product performance, safety and efficacy.

Particle size is typically characterised by the 10th, 50th and 90th percentile or D10, D50 and D90 which is our standard way of reporting. Testing for particle size is covered under the company’s scope of Accreditation and performed to ISO 17025.

Consumer Product Safety Commission testing

Using bespoke testing equipment which complies with the CPSC requirements, we can test e-liquid bottles for compliance against the United States Consumer Product Safety Commission requirements for Child Safety under the 2016 Child Nicotine Poison Prevention Act.

Testing involves determining the amount of e-liquid released from an e-liquid bottle when put under a horizontal force, that mimics squeezing the bottle. Testing is typically performed in triplicate to ensure data quality and compliance.

Tobacco Products Directive (TPD)/Tobacco and Related Products Regulations (TRPR)

From nicotine dose consistency to carbonyl content in aerosol, Inter Scientific offers a full suite of TPD/TRPR compliant tests using accredited methods. The test methods are harmonised across all European testing standards such as AFNOR. This enables our clients to notify Europe-wide without the need for further testing.

Testing is performed to appropriate ISO standards for vaping and vape product testing and is covered under the companies’ scope of accreditation for ISO 17025.

Testing includes:

Nicotine Dose Consistency
Nicotine Declared Dose
Carbonyls in Aerosol
Metals in Aerosol

Additionally, where further testing may also be required for certain products to demonstrate an absence of certain analytes this can be carried out.

Emirates Authority for Standardization and Metrology (UAES 50:30)

Vape products sold in the UAE must comply with UAES 50:30, which not only includes being tested for nicotine content and metals analysis, but must also include the determination of an absence of caffeine and taurine. Analysis is typically performed in e-liquid and must be retested annually.

Inter Scientific offers testing in accordance with ISO 17025 for products seeking to apply for ESMA licensing or for annual recertification.

Stability Studies

Description Title

Inter Scientific is certified by the MHRA to GMP compliance for the QC release of investigative medicinal products (IMP). All appropriate methods are validated in accordance with GMP to support client studies and product release.

QC/Batch Testing

For manufacturers who require quality control or batch testing, Inter Scientific offer rapid-turnaround of samples at no extra cost. Whether needed for export/import compliance or to ensure product safety, Inter Scientific offers a range of fast and reliable testing services.

Test Type	Analyte
Harmful and Potentially Harmful Constituents	Acetaldehyde Acetyl propionyl Acrolein Acrylonitrile Benzene Benzyl acetate Butyraldehyde Cadmium Chromium Crotonaldehyde Diacetyl Diethylene glycol Ethyl acetate Ethyl acetoacetate Ethylene glycol Formaldehyde Furfural Glycerol Glycidol Isoamyl acetate Isobutyl acetate Lead Menthol Methyl acetate N-butanol Nickel Nicotine NNK (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone) NNN (N-nitrosonornicotine) Propionic acid Propylene glycol Propylene oxide Toluene Benzaldehyde Vanillin Cinnamaldehyde
Tobacco Products Directive/Tobacco and Related Products Regulations 2016	Nicotine dose consistency Nicotine dose Carbonyls: Formaldehyde Acetaldehyde Acetone Acrolein Propionaldehyde Crotonaldehyde Methyl ethyl ketone Benzaldehyde Butyraldehyde Metals: Cd, Cadmium As, Arsenic Cr, Chromium Pb, Lead
Microbiology/Toxicology	TAMC TYMC Bile-tolerant Gram-negative bacteria Pseudomonas aeruginosa Staphylococcus aureus
End of device life or pod life	Minimum number of inhalations
Particle Size Determination	Particle Size (D10, D50 and D90)
Uniformity of delivered dose	Variation of nicotine delivery over 3 or more doses
Mean delivered dose	The average nicotine delivered per dose
Uniformity of dosage units	The average nicotine content per unit
Ratio of freebase to protonated nicotine	Determination of freebase nicotine : protonated nicotine
Chiral nicotine analysis (for synthetic nicotine)	The ratio of R:S nicotine
Water Activity	Water Activity (Aw)
Water Content	Water content in % w/w
pH in aerosol	pH
pH of e-liquid	pH
Viscosity of e-liquid	Viscosity of liquid (Centipoise)
Density of e-liquid	Density (g/cc)
Pod/Device fill volume	The extractable volume of e-liquid in a pod/device
Total Particulate Matter/EVM	Mass of aerosolised e-liquid per puff/dose
CPSC bottle testing	Compliance against CPSC requirements

Our Oral Nicotine Product testing services

Oral Nicotine Products

Oral Nicotine products, also known as Modern Oral Nicotine (MON) products are an emerging product category in Europe and the United States. Unlike traditional tobacco pouch products, oral nicotine products do not contain tobacco leaf, but rather contain nicotine held on a solid substrate. Oral Nicotine products may be pouches or solid/dissolvable lozenges.

Nicotine Dissolution

Dissolution testing of nicotine from oral nicotine products is used to determine the rate of liberation of nicotine from products ensuring nicotine release is acceptable. This testing may also help inform product design, some products seeking to deliver nicotine more rapidly, while others seek to achieve sustained release over a longer period of time. Inter Scientific has state-of-the-art Sotax dissolution apparatus which complies with United States Pharmacopoeia 4 and ICH Q4B enabling this testing.

Stability Studies

Whether supporting product development or continuing stability commitments, our in-house, ICH complaint stability storage allows Inter Scientific to conduct stability studies types of oral nicotine product in both long term storage or accelerated stability regimes. Key considerations for oral nicotine products are their stability, including microbial stability. Due to the presence of water in many products, the efficacy of preservative may be of particular importance for products safety.

Oral Nicotine Pharmaceuticals

Inter Scientific is certified by the MHRA to GMP compliance for the QC release of investigative medicinal product (IMP). All appropriate methods are validated in accordance with GMP to support client studies and product release. Testing includes both raw materials, including Nicotine USP/EP and finished product.

QC/Batch Testing

Oral nicotine product product testing suite:

Test Type	Analyte
Harmful and Potentially Harmful Constituents	Carbonyls: Formaldehyde Acetaldehyde Acetone Acrolein Propionaldehyde Crotonaldehyde Methyl ethyl ketone Benzaldehyde Butyraldehyde Diacetyl Acetyl Propionyl Nitrosamines: NNN/NNK Metals: Ag, Silver Al, Aluminium As, Arsenic Cd, Cadmium Co, Cobalt Cr, Chromium Mo, Molybdenum Ni, Nickel Pb, Lead Sb, Antimony Sn, Tin V, Vanadium Zn, Zinc
Microbiology/Toxicology	TAMC TYMC Staphylococcus aureus Pseudomonas aeruginosa Preservative efficacy testing (PET)
Uniformity of dosage units	The average nicotine content per unit
Dissolution of Nicotine	Nicotine (USP 4)
Nicotine Assay	Nicotine
Nicotine Related Substances	Nicotine n-oxide Cotinine Nornicotine Anatabine Myosmine Anabasine beta-Nicotyrine
Ratio of freebase to protonated nicotine	Determination of freebase nicotine: protonated nicotine
Chiral nicotine analysis (for synthetic nicotine)	The ratio of R:S nicotine
Water Activity	Water Activity (Aw)
Water Content	Water content in % w/w
pH	pH
Loss on drying	Mass change

Our Synthetic Nicotine product testing suite

Synthetic Nicotine Testing

Synthetic nicotine or non-tobacco derived nicotine differs from tobacco-derived in its synthesis and purification. Unlike tobacco derived nicotine, which is extracted from tobacco, synthetic nicotine may be chemically synthesised or synthesised in a biological system. When biologically produced, such as in a tobacco plant, nicotine is found as S-nicotine, which is neurochemically active.

In order to evaluate the potency and safety of tobacco products containing synthetic nicotine the ratio or R-nicotine to S-nicotine should be evaluated. Further, depending on the manufacturing and purification methods used, residually solvents many need to be measured. This is typically done in the nicotine as a raw material.

Synthetic Nicotine Testing Suite:

Test Type	Analyte
Identification	By UV-absorption
Specific Rotation	Tested in alcohol
Water Content	Water
Heavy Metals	Cd, Cadmium As, Arsenic Cr, Chromium Pb, Lead
Purity/Assay	Nicotine
Nicotine Related Substances	Nicotine n-oxide Cotinine Nornicotine Anatabine Myosmine Anabasine beta-Nicotyrine
Tobacco Specific Nitrosamines	NNN & NNK
Residual Solvents	Dependant on manufacturing process
Racemic Makeup	R-Nicotine : S-Nicotine

Our Nicotine Product Stability Studies service

Nicotine Product Stability Studies

Stability studies, or shelf-life studies as they are commonly referred to, are designed to ensure that a product is of appropriate quality and safety over its intended life. These studies are typically conducted on at least two (2) batches of product on a three (3) replicate basis.

Long term testing is performed, sometimes with accelerated conditions where the temperature and humidity of storage are tightly controlled. These conditions may differ from industry to industry, however ICH guidance for the pharmaceutical industry is generally accepted as best practice for vape product testing. This differs from some ISO standards for tobacco products.

Here at Inter Scientific, we have state-of-the-art stability storage onsite using Binder and Memmert chambers to ensure the strictest of control over both the temperature and humidity. Additionally, as our storage is onsite, there are no delays in the commencing of stability studies and not risk of product being lost, damaged or incurring a temperature excursion.

Study	Storage condition	Minimum time period covered by data submission
Long-term*	25 ± 2ºC/60% RH ± 5% RH or 30ºC ± 2ºC/65% RH ± 5% RH / OR / 30ºC ± 2ºC/65% RH ± 5% RH	12 months
Intermediate**	30ºC ± 2ºC/65% RH ± 5% RH	6 months
Accelerated	40ºC ± 2ºC/75% RH ± 5% RH	6 months

*It is up to the applicant to decide whether long-term stability studies are performed at 25 ± 2ºC/60% RH ± 5% RH or 30ºC ± 2ºC/65% RH ± 5% RH.

**If 30ºC ± 2ºC/65% RH ± 5% RH is the long-term condition, there is no intermediate condition.

Stability studies typically last from 12 to 24 months for nicotine containing products with several testing points over the course of storage.

Inter Scientific are world experts in the stability of nicotine products and draw on a wealth of knowledge from 15 + years of nicotine formulation development in vape, oral and transdermal products.

Stability Study Testing Suite for Nicotine Containing Products:

Test Type	Analyte
Harmful and Potentially Harmful Constituents	Dependant on product format
Microbiology/Toxicology	TAMC TYMC Bile-tolerant Gram-negative bacteria Pseudomonas aeruginosa Staphylococcus aureus
End of device life or pod life	Minimum number of inhalations
Particle Size Determination	Particle Size (D10, D50 and D90)
Uniformity of delivered dose	Variation of nicotine delivery over 3 or more doses
Mean delivered dose	The average nicotine delivered per dose
Uniformity of dosage units	The average nicotine content per unit
Ratio of freebase to protonated nicotine	Determination of freebase nicotine : protonated nicotine
Chiral nicotine analysis (for synthetic nicotine)	The ratio of R:S nicotine
Water Activity	Water Activity (Aw)
Water Content	Water content in % w/w
pH in aerosol	pH
pH of e-liquid	pH
Viscosity of e-liquid	Viscosity of liquid (Centipoise)
Density of e-liquid	Density (g/cc)
Pod/Device fill volume	The extractable volume of e-liquid in a pod/device
Total Particulate Matter/EVM	Mass of aerosolised e-liquid per puff/dose
CPSC bottle testing	Compliance against CPSC requirements
Nicotine Related Substances	Nicotine n-oxide Cotinine Nornicotine Anatabine Myosmine Anabasine beta-Nicotyrine
Tobacco Specific Nitrosamines	NNN & NNK
Racemic Makeup	R-Nicotine : S-Nicotine
Flavour measurement	Dependant on flavour compounds

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Let’s talk about your project

To discover more about how we can support you to sell your nicotine products safely and legally, fill in the form, or call to set up a meeting at 0333 344 2272.