TPD2/PMTA HPHC testing

We offer a full range of analytical tests to support TPD2, PMTA and HPHC submissions.

Our comprehensive suite of analytical instrumentation allows us to perform routine testing for regulatory submission such as TPD2, PMTA and HPHC but also gives us the flexibility to tackle any challenges that may arise during your production phase

Analysis of the emissions from ENDS and e-liquids provides an insight into the safety and quality of the product – the list of target analytes having been determined by regulatory bodies as compounds of concern.

To discuss your testing requirements call: 01357 524023

All of the following TPD2/PMTA HPHC testing can be carried out on aerosol and/or liquid samples unless stated otherwise.

• CML (Cartomiser Mass Loss) or ACM (Aerosol Collected Mass) (Emissions Only)
  • This test can be used to determine full depletion of a device, usually a pre-filled cartomiser, by means of weighing before and after each puff block.

• Nicotine Dose and Consistency of Dose (Emissions Only)
  • Although the concentration of nicotine in the e-liquid is known, the dose in the aerosol will vary depending on the device used to vape the e-liquid. Consistency of this dose throughout the vaping experience is paramount and is determined by means of triplicate analysis with each individual dose reported alongside the mean, SD and %RSD values.

• Major Components
  • Target analytes are:
    • Nicotine
    • Propylene glycol (PG)
    • Glycerin (VG)
    • Menthol
    • Water
  • This test will determine the amounts of these compounds in the aerosol/liquid.

• Impurities
  • Target analytes are:
    • Diethylene glycol
    • Ethylene glycol
    • Glycidol
    • Ammonia
  • Diethylene glycol and ethylene glycol are generally accepted as being present as impurities in PG and VG.
  • Glycidol may be observed as an intermediate in the production of acrolein from glycerin.
  • There is a school of thought that the addition of ammonia will increase the proportion of free nicotine in the aerosol and subsequently increase the absorption of nicotine by the user.

• Monocarbonyl Compounds
  • Target analytes are:
    • Formaldehyde
    • Acetaldehyde
    • Propionaldehyde
    • Butyraldehyde
    • Crotonaldehyde
    • Acrolein
    • Acetoin
  • These compounds may be present in their own right in the e-liquid formulation or can also be formed during the vaping experience. Regulatory bodies are particularly interested in the levels of these carbonyl compounds present in the aerosol as they may have an adverse effect on human health when inhaled at sufficient concentration.

• Dicarbonyl Compounds
  • Target analytes are:
    • 2,3-Butanedione (diacetyl)
    • 2,3-Pentanedione (acetyl proprionyl)
    • 2,3-Hexanedione
    • 2,3-Heptanedione
    • Glyoxal
    • Methyl glyoxal
  • It is generally accepted that the diketone compounds are most likely to be present as part of the formulation itself, not formed during vaping.
  • Glyoxal and methyl glyoxal may be observed as intermediates in the formation of certain monocarbonyl compounds.

• VOCs (Volatile Organic Compounds)
  • Target analytes are:
    • Acrylonitrile
    • Benzene
    • 1,3-Butadiene
    • Isoprene
    • Toluene
  • Screening analysis can also be carried out, whereby the other major components of the aerosol/liquid are reported. This data can be used to produce a toxicological evaluation of your product.

• Elemental Impurities (Metals)
  • Target analytes are those listed in the ICH Q3D Guidelines (July 2013).
  • Metals may be introduced into the aerosol and liquid in a number of ways, e.g. via hardware (coils, tanks etc), manufacturing processes and e-liquid storage containers.

• Aromatic Amines
  • Target analytes are:
    • 4-Aminobiphenyl
    • 1-Aminonaphthalene
    • 2-Aminonaphthalene
  • The FDA considers these compounds to be harmful and potentially harmful constituent (HPHCs).

• Nicotine Related Substances
  • Target analytes:
    • Anabasine
    • Anatabine
    • Cotinine
    • Myosmine
    • Nicotine-n-oxide
    • b-nicotyrine
    • Nornicotine
  • The FDA considers anabasine specifically to be a potentially harmful constituent (HPHCs). The other alkaloid compounds listed are included in this testing.

• Tobacco Specific Nitrosamines (TSNAs)
  • Target analytes:
    • N-Nitrosoanabasine (NAB)
    • N-Nitrosoanatabine (NAT)
    • 4-(Methylnitrosoamino)-1-(3-pyridyl)-1-butanone (NNK)
    • N-Nitrosonornicotine (NNN)
  • These compounds are classed as carcinogens and are formed from nicotine and related compounds.

• Benzo(a)pyrene
  • This polycyclic aromatic compound can be formed during combustion of organic matter and is classed as a carcinogen.

• Organic Acids
  • Target analytes are:
    • Acetic acid
    • Benzoic acid
    • Formic acid
    • Glycolic acid
    • Lactic acid
    • Levulinic acid
    • Oxalic acid
    • Pyruvic acid
  • These low molecular weight acids are classed as highly irritant.

Further testing on the e-liquid itself may give corroborating data to ascertain the origin of any compounds observed.

Other analytes may be targeted upon request.

In the interest of our clients product security we are keen to retain our independence however if required we work in partnership with Independent leading Toxicology and Regulatory consultants and can offer a full TPD Notification solution if required.