Electronic Nicotine Delivery Systems (ENDS)

McKinney 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

McKinney 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. McKinney Specialty Labs also has fully validated methods for the full list from the PMTA ENDS guidance document.

Our scientists utilize internationally recognized and validated test methods 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

McKinney 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-211 Nitrosamines in E-Liquid and Aerosol by LC-MS/MS: NAB, NAT, NNK, NNN
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-224 Primary Constituents in E-Liquid and Aerosol by GC/FID: Nicotine, Menthol, Propylene glycol, Ethylene glycol, Diethylene glycol, Glycerin
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
AM-253 Polycyclic Aromatic Hydrocarbons (PAHs) in E-Liquid and Aerosol by GC/MS: Benzo[c]fluorene Benz[j]aceanthrylene/benz[e]aceanthrylene, Benzo[c]phenanthrene Benzo[a]pyrene, Benzo[a]anthracene Dibenzo[a,h]anthracene, Cyclopenta[c,d]pyrene Indeno[1,2,3-c,d]pyrene, Chrysene Benzo[g,h,i]perylene, 5-Methylchrysene Dibenzo[a,l]pyrene, Benzo[b]fluoranthene Dibenzo[a,e]pyrene, Benzo[k]fluoranthene Dibenzo[a,i]pyrene, Benzo[j]fluoranthene Dibenzo[a,h]pyrene
AM-274 Glycidol in E-Liquid and Aerosol by GC/MS
AM-275 Esters in E-Liquid and Aerosol by GC/MS: Benzaldehyde, Benzyl acetate, Cinnamaldehyde, Ethyl acetate, Ethyl acetoacetate, Isoamyl acetate, Isobutyl acetate, Methyl acetate, N-butanol, Vanillin
AM-280 Particle Size Analysis of ENDS Aerosol by MOUDI cascade impactor
AM-281 Ammonia in E-Liquid and Aerosol by IC
AM-282 Organic Acids in E-Liquids and Aerosol by HPLC/IC: Acetic acid, Formic acid, Benzoic acid, Glycolic acid, Lactic acid, Propionic acid, Malic acid
AM-283 Volatile Organic Compounds in E-Liquid and Aerosol by GC/MS: 1,3-butadiene, Acrylonitrile, Benzene, Ethylene oxide, Furan, Furfurol, Isoprene, Nitromethane, Propylene oxide, Vinyl acetate, Vinyl chloride, Toluene
AM-285 Karl Fischer Titration for the Analysis of Water in E-Cigarette Liquids and Aerosol
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