Ultraviolet and visible absorption spectrophotometric methods of chemical analysis are routinely used in the pharmaceutical industry. A candidate method for a new application usually originates in a research and development laboratory which then transfers it to a destination laboratory such as a quality control or manufacturing support laboratory. Transfer of a validated analytical method, unfortunately, does not often proceed smoothly. The destination laboratory may discover that the transferred method is difficult to implement routinely within its own laboratory culture. If disappointing test analysis results cannot be improved to meet acceptance criteria, the analytical method may need to be rejected entirely or returned to the research and development laboratory for further refinement. Either scenario is extremely costly and unproductive from a time and budget perspective.While much of the focus during method development is on validation of the analytical method, qualification of the spectrophotometer itself seems to be weighted much less within the overall quality scheme. This presentation will describe how a metrological approach to spectrophotometer qualification can provide evidence-based criteria for the spectrophotometer to be deemed �fit for its intended purpose.'' Metrological concepts such as science-based calibration, measurement traceability and uncertainty analysis will be discussed with respect to an analytical method that can produce verifiable measurement results in the destination laboratory that have scientific validity and integrity.

Metrological qualification of spectrophotometers for successful analytical method transfer

248th National Meeting (2014)

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