Method Validation

Enthalpy Specialty Labs develops in-house methods based on request and industry need. All developed methods are validated in accordance with guidelines set by the following guidelines and regulations:

• [1] International Conference on Harmonization (ICH), reference 6.1
• [2] US Pharmacopeia (USP), reference 6.2
• [3] International Standards Organization (ISO), reference 6.3
• [4] International Union of Pure and Applied Chemistry (IUPAC), reference 6.4
• [5] US Food & Drug Administration (FDA), reference 6.8

Future FDA Method Validation Guidance
The FDA is in the process of issuing guidance for method validation. Enthalpy submitted comments on the FDA’s draft guidance for industry on “Validation and Verification of Analytical Testing Methods used for Tobacco Products” in February of 2022. Read our full comments to Docket No. FDA-2021-D-0756

Enthalpy Specials
Some of our unique, cutting-edge methods include:

• Metals in aerosol collected via electrostatic precipitation
• Derivatized glycidol in e-liquid, aerosol, smoke, and HTP
• Synthetic nicotine determination using chiral chromatography
• Low-level volatiles collected in sorbent media in e-liquid, aerosol, and HTP
• Particle size analysis via ELPI
• Organic acids via GC-FID

Our method validations address the following criteria:

• Selectivity – Ability to measure desired analyte in a complex mixture
• Linearity – Proportionality of measured value to concentration
• Range – Concentration interval where method is precise, accurate and linear
• Accuracy – Agreement between measured and real value
• Precision – Agreement between a series of measurements
• Repeatability
• Intermediate-precision
• Reproducibility
  • Limit of Detection (LOD) – Lowest amount of analyte that can be detected
  • Limit of Quantitation (LOQ) – Lowest amount of analyte that can be measured
  • Robustness – Capacity of method to remain unaffected by small, but deliberate variations in method procedure