...a major e-liquid manufacturer needed to carry out extensive studies to support their regulatory objectives and submissions for the PMTA approval process. How did they succeed?
A major e-liquid manufacturer needed to carry out extensive studies to support their regulatory objectives and submissions for the PMTA approval process.
Recommended as a consultative problem solver with deep experience in e-liquids, Quantum Analytics Group was asked to meet with the manufacturers stakeholders to spearhead the project.
The client had real concerns about outcomes. Would the same e-liquid they produced now pass the more stringent FDA tests? Would other, more dangerous chemicals be found in the liquid?
Even though staff and equipment were readily available, the client team was unclear on the best approach to this kind of testing.
The elephant in the room was the looming deadline for FDA submission.
“In this kind of high-pitched analysis, it’s best to keep things as simple as possible…and keep the regulatory objectives in mind – always”.
For the tests, Quantum analyzed samples of each e-liquid by several compound-specific methods including gas chromatography-mass spectrometry and HPLC with UV detection.
“During the actual testing, our equipment scanned at a ppb level so that any new compounds, outside the 33 that we knew, could easily be identified - the accuracy of this tool makes it a great identifier”.
“We use the most current NIST spectral library to analyze any peaks that stood out from the GCMS analysis”.
“We knew exactly which 33 compounds we were dealing with out of the 93 that the FDA had identified as HPHCs…and we knew which methodologies would work right off the bat. That’s just pure experience”.
No additional compounds were identified from any of the tests.
A highly experienced and consultative analytical laboratory can save a manufacturing company millions.