Electronic Nicotine Delivery Systems (ENDS)

Enthalpy Specialty Labs is a World Leader in ENDS Testing

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

Overview

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.

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.

Testing Details

Enthalpy Specialty Lab’s ENDS Product services fulfill the requirements of:
  • FDA (USA) HPHC Testing
  • FDA (USA) Premarket Tobacco Application (PMTA) Testing
  • EU-TPD Testing

We have the capability to analyze the following constituents/chemicals from the 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
ENDS HPHC Methods for E-liquid and Aerosol
Method Description
AM-221 Selected Primary Aromatic Amines (PAAs) in E-Liquid and Aerosol by GC/MS: 1-Aminonaphthalene, 2-Aminonaphthalene, 3-Aminobiphenyl, 4-Aminobiphenyl, o-Toluidine
AM-235 Selected Metals in E-Liquid by ICP/MS: Chromium, Iron, Nickel, Copper, Zinc, Arsenic, Cadmium, Tin, Silver, Lead, Beryllium, Cobalt, Selenium
AM-238 Nicotine Degradants in E-Liquid and Aerosol by LC-MS/MS: Myosmine, Nornicotine, ß-Nicotyrine, Anatabine, Anabasine, Cotinine, Nicotine-N-oxide
AM-244 Carbonyls in E-Liquid and Aerosol by LC-MS/MS:Diacetyl, 2,3-Pentanedione, Formaldehyde, Acetaldehyde, Acrolein, Crotonaldehyde, Butyraldehyde, Furfural
AM-249 Metals in E-liquids and Aerosol by ICP-MS: Chromium, Iron, Nickel, Copper, Zinc, Arsenic, Cadmium, Tin, Silver, Lead, Beryllium, Cobalt, Selenium
ENT073 Karl Fischer Titration of Water in E-Cigarette Liquids and Aerosol
ENT184 Primary Constituents in E-Liquid by GC-FID: Nicotine, Menthol, Ethanol, Diethylene glycol, Ethylene glycol, Glycerol, Propylene glycol
ENT185 Primary Constituents in Aerosol by GC-FID: Nicotine, Menthol, Ethanol, Diethylene glycol, Ethylene glycol, Glycerol, Propylene glycol
ENT203 Glycidol in E-Liquid and Aerosol by GC/MS
ENT208A Volatile Organic Compounds in E-Liquid and Aerosol Collected on Sorbent Media (Low-Level) by GC/MS: Acrylonitrile, Benzene, Propylene oxide, Toluene
ENT209 Esters in E-liquid by GC/MS: Benzyl acetate, Ethyl acetate, Ethyl acetoacetate, Isoamyl acetate, Isobutyl acetate, Methyl acetate, N-butanol, Benzaldehyde, Cinnamaldehyde, Vanillin
ENT211 Nitrosamines in E-Liquid and Aerosol by GC/MS: NAB, NAT, NNK, NNN
ENT217 Benzo[a]pyrene in E-Liquid and Aerosol by GC/MS
ENT218 Esters in Aerosols by GC/MS: Benzyl acetate, Ethyl acetate, Ethyl acetoacetate, Isoamyl acetate, Isobutyl acetate, Methyl acetate, N-butanol, Benzaldehyde, Cinnamaldehyde, Vanillin
ENT307 Ammonia in E-Cigarette Liquid and Aerosol by HPLC/IC
ENT327 Organic Acids in E-Cigarette Liquid and Aerosol by IC: Acetic acid, Benzoic acid, Formic acid, Glycolic acid, Lactic acid, Oxalic acid, Propionic acid
ENT520 Aerosol Particle Size Analysis of ENDS via MOUDI cascade impactor
TOX-011 Total Yeast/Mold Count – FDA BAM: 8ed. Ch18 Total Aerobic Plate Count – AOAC 966.23
Physical Properties Boiling point, viscosity, coil temperature, aerosol temperature, pH, water content and activity, density