Media Formulation Parameters Predicted Observed PE ratio 0.1 N HCl Test Formulation 70 mg Internal AUClast 1605.582 1656.903 -3.1 0.97 Cmax 93.48553 85.443 9.4 1.09 Preductal® MR 35 mg Internal AUClast 570.8056 592.5588 -3.7 0.96 Cmax 65.57775 69.366 -5.5 0.95 Avg Internal AUClast 1088.194 1124.731 3.4 0.97 Cmax 79.53164 77.4045 7.4 1.03 pH 4.5 AB Test Formulation 70 mg Internal AUClast 1639.706 1656.903 -1 0.99 Cmax 71.47473 85.443 -16.3 0.84 Preductal® MR 35 mg Internal AUClast 597.2477 592.5588 0.8 1.01 Cmax 60.22211 69.366 -13.2 0.87 Avg Internal AUClast 1118.477 1124.731 0.9 0.99 Cmax 65.84842 77.4045 14.8 0.85 pH 6.8 PB Test Formulation 70 mg Internal AUClast 1638.416 1656.903 -1.1 0.99 Cmax 68.84238 85.443 -19.4 0.81 Preductal® MR 35 mg Internal AUClast 601.4235 592.5588 1.5 1.01 Cmax 60.89449 69.366 -12.2 0.88 Avg Internal AUClast 1119.92 1124.731 1.3 1 Cmax 64.86843 77.4045 15.8 0.84 Water Test Formulation 70 mg Internal AUClast 1624.774 1656.903 -1.9 0.98 Cmax 68.50113 85.443 -19.8 0.8 Preductal® MR 35 mg Internal AUClast 607.2892 592.5588 2.5 1.02 Cmax 61.58081 69.366 -11.2 0.89 Avg Internal AUClast 1116.032 1124.731 2.2 0.99 Cmax 65.04097 77.4045 15.5 0.84 AB- acetate buffer, PB-phosphate buffer

Table 4: Summary of internal validation parameters in different media.

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