Method Validation

The tables below present method validation data for applying IO™ fiber optic dissolution monitoring to an immediate-release product (*Hoffman-La Roche, Basel, Switzerland). The drug studied was a soft gelatin capsule containing 200mg of active substance dissolved in a mono- and diglyceride filling. Validation studies were performed in accordance with standard USP and ICH protocols. Although no excipient particles existed in this case, turbidity was still generated due to metal oxide pigments from the capsule shell.

The tables presented from this study summarize the validation experiments conducted, the acceptance criteria for the results of these measurements, and the results of the validation experiments. It was concluded that these results meet all the acceptance criteria for linearity (coefficient of correlation and y-intercept), precision, and accuracy. In addition, no significant differences (p=95%) were observed in the fiber optic data when compared to the existing reference method based on manual sampling and filtration.