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 |