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PMTA Testing

Regardless of whether your products are e-cigarettes (ENDS), e-liquids (ENDS), e-vapor devices (ENDS), cigarettes, cigars, oral tobacco products, gels or tobacco free oral nicotine products, Labstat offers validated methods for all of FDA’s PMTA ENDS (Premarket Tobacco Product Application for Electronic Nicotine Delivery Systems) and HPHC (Harmful and Potentially Harmful Constituents) testing in support of PMTA (Premarket Tobacco Product Application) or Substantial Equivalence sumbmissions. Our validation process is designed to meet regulatory standards to ensure that submitted data is reliable and defensible

Do you need assistance preparing for and filing your PMTA. We can provide an end-to-end solution. Please contact us.

Premarket Tobacco Product Application for Electronic Delivery Systems Testing (PMTA ENDS)

The FDA has suggested the following compounds of interest listed in bold:

Group Instrument Analytes
Volatiles GC-MS (SIM) 1,3-butadiene, acrylonitrile, benzene, ethylbenzene, ethylene oxide, furan, isoprene, nitromethane, propylene oxide, toluene, vinyl acetate, vinyl chloride
Carbonyls GC-MS (SIM) 2,3-butanedione (diacetyl), 2,3-heptanedione, 2,3-hexanedione, 2,3-pentanedione (acetyl propionyl), 3-buten-2-one (MVK), acetaldehyde, acetoin, acetol, acetone, acrolein, butyraldehyde, crotonaldehyde, ethyl acetoacetate, formaldehyde, glycolaldehyde, glyoxal, isobutyraldehyde, methyl ethyl ketone, methylglyoxal, propionaldehyde
Metals ICP-MS aluminum, arsenic, beryllium, cadmium, chromium, cobalt, copper, iron, lead, manganese, molybdenum, nickel, selenium, silver, strontium, tin, titanium , tungsten, zinc, zirconium
Composition GC-TCD/FID diethylene glycol, ethylene glycol, glycerol, NFDAM, nicotine, propylene glycol, triacetin, water, menthol
Glycidol GC-MS (SIM) glycidol
Nitrosamines, tobacco specific LC-MS/MS 4-[methyl(nitroso)amino]-1-(3-pyridinyl)-1-butanone (NNK), N-nitrosoanabasine (NAB), N-nitrosoanatabine (NAT), N-nitrosonornicotine (NNN)
Flavourants GC-MS (SIM) 1-butanol, benzyl acetate, ethyl acetate, furfural, isoamyl acetate, isobutyl acetate, methyl acetate

For the assessment of unprotonated nicotine and nicotine salts:

Group Instrument Analytes
pH pH electrode pH
Benzoic acid HPLC-UV benzoic acid
Organic Acids HPLC-UV acetic acid, benzoic acid, formic acid, glycolic acid, lactic acid, oxalic acid
Propionic acid GC-MS (SIM) propionic acid

Compounds that also may be of interest:

Group Instrument Analytes
Gold ICP-MS gold
Nicotine Degredation Products LC-MS/MS anabasine, anatabine, cotinine, myosmine, nicotine, nicotine-N-oxide, nornicotine, β-nicotyrine
Water Activity WA water activity
Water (Karl Fisher) KF water