Method Validation

McKinney Specialty Labs develops methods based on request and industry need. All new methods are validated in accordance with the following guidelines:

• [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

McKinney Specialty Labs participates, along with other institutions (e.g., other analytical Labs including FDA), in intra-laboratory proficiency studies for new methods and industry reference products. These proficiency studies are conducted by Cooperation Centre for Scientific Research Relative to Tobacco (CORESTA).

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