Electronic Nicotine Delivery Systems (ENDS)

Below are some of our specialized capabilities and services:

• HPHC
• Toxicology
• Stability Studies
• End of device or pod life (EOL)
• Particle Size Determination
• Ambient air testing
• Exhaled breath testing
• Synthetic nicotine testing

Enthalpy Specialty Labs offers a range of test methods for the collection and analysis of harmful and potentially harmful constituents (HPHCs) in electronic nicotine delivery systems (ENDS) and their associated e-liquids. Most common methods include the analysis of primary constituents (such as nicotine, propylene glycol, and vegetable glycerin), carbonyl compounds (such as diacetyl and pentanedione), and metals. Enthalpy also has fully validated methods for the full list from the 2019 PMTA ENDS guidance document.

Our labs have analyzed thousands of e-cigarette devices (including refillable tank systems, pod-based systems, and proprietary client devices) and e-liquids from hundreds of manufacturers, vendors, and consumers. Our thorough knowledge of FDA HPHCs in tobacco and smoke has allowed for quick and robust method transfer to e-cigarette products.

Enthalpy Specialty Labs operates multiple smoke labs capable of e-cigarette aerosol sample collection between its Richmond, VA and Durham, NC laboratories, allowing for redundancy and flexibility in our testing processes. We offer analysis and testing of aerosol and e-liquids for the presence of nicotine, propylene glycol, glycerin, carbonyls (ie, diacetyl, formaldehyde, etc.),

Our scientists utilize internationally recognized test methods—enhanced and adapted for our laboratories—to deliver accurate, reliable, and consistently high-quality data. All ENDS methods have been validated for quality assurance, including evaluation for linearity, recovery from the matrix, and verification of detection limits. All analytical equipment is qualified and calibrated with full documentation. Our laboratories offer testing that is internationally accredited by A2LA to the ISO 17025 standard.

• FDA (USA) HPHC Testing
• FDA (USA) Substantial Equivalence (SE) Testing
• FDA (USA) Premarket Tobacco Application (PMTA) Testing
• EU-TPD Testing

We have the capability to analyze the following constituents/chemicals from the 2019 FDA PMTA ENDS guidance document:

• 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 from any source, including total nicotine, unprotonated nicotine, and nicotine salts
• NNK (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone)
• NNN (N-nitrosonornicotine)
• Propionic acid
• Propylene glycol
• Propylene oxide
• Toluene